CADN26X • California Dentists 2026

Table of Contents

CADN26X • California Dentists 2026

How to Receive Credit

NetCE 2 Hour Course #51294 • The California Dental Practice Act

51294 • The California Dental Practice Act

1. INTRODUCTION

2. DENTISTRY DEFINED: SCOPE OF PRACTICE

3. LICENSURE

4. VIOLATIONS AND PENALTIES

5. LAWS GOVERNING THE PRESCRIPTION OF DRUGS

6. REPORTING OF ABUSE AND NEGLECT

7. CONCLUSION

8. RESOURCES

Works Cited

NetCE 2 Hour Course #58584 • Infection Control for Dental Professionals: The California Requirement

58584 • Infection Control for Dental Professionals: The California Requirement

1. INTRODUCTION

2. INFECTION CONTROL REGULATIONS

3. MODES OF TRANSMISSION

4. STANDARD PRECAUTIONS

5. TRANSMISSION-BASED PRECAUTIONS

6. PROTECTING DENTAL HEALTHCARE WORKERS

7. CONCLUSION

8. DENTAL BOARD OF CALIFORNIA GENERAL PROVISIONS: SECTION 1005. MINIMUM STANDARDS FOR INFECTION CONTROL

Works Cited

NetCE 2 Hour Course #55290 • Responsibilities and Requirements of Prescribing Schedule II Opioid Drugs

55290 • Responsibilities and Requirements of Prescribing Schedule II Opioid Drugs

1. INTRODUCTION

2. SCOPE OF THE PROBLEM

3. PAIN MANAGEMENT APPROACHES IN DENTISTRY

4. CREATING A TREATMENT PLAN AND ASSESSMENT OF ADDICTION RISK

5. DENTAL OFFICE PROCEDURES FOR MANAGING VULNERABLE OR SUBSTANCE USE DISORDER PATIENTS

6. REGULATORY REQUIREMENTS FOR PRESCRIBERS AND DISPENSERS

7. CONCLUSION

8. APPENDIX: LAWS AND REGULATIONS IN CALIFORNIA

Works Cited

NetCE 5 Hour Course #51914 • Dental Care for Patients with Disabilities

51914 • Dental Care for Patients with Disabilities

1. INTRODUCTION

2. AUTOIMMUNE DISEASES

3. IMMUNOSUPPRESSIVE CONDITIONS

4. DISEASES AND CONDITIONS AFFECTING NEUROMUSCULAR COORDINATION

5. CONDITIONS CAUSING COGNITIVE IMPAIRMENT

6. CONCLUSION

Works Cited

Evidence-Based Practice Recommendations Citations

NetCE 4 Hour Course #54680 • Caries-Prone Patients: Prevention, Assessment, and Intervention

54680 • Caries-Prone Patients: Prevention, Assessment, and Intervention

1. INTRODUCTION

2. THE CARIES PROCESS

3. CARIES LESION DETECTION METHODS

4. ORAL CARE HABITS

5. CARIOUS DIETS

6. POPULATIONS AT RISK

7. CARIES PREVENTION PRODUCTS AND PROCEDURES

8. CARIES RISK ASSESSMENT

9. NUTRITIONAL COUNSELING

10. CASE SCENARIOS

11. CONCLUSION

12. RESOURCES

Works Cited

NetCE 10 Hour Course #50201 • Botulinum Toxin and Dermal Fillers for Facial Aging

50201 • Botulinum Toxin and Dermal Fillers for Facial Aging

1. INTRODUCTION

2. TERMINOLOGY

3. BACKGROUND

4. THE PROCESSES OF FACIAL AGING

5. BOTULINUM TOXIN

6. SOFT TISSUE (DERMAL) FILLERS

7. DEOXYCHOLIC ACID

8. INDIVIDUALIZED ASSESSMENT AND TREATMENT PLANNING

9. THE MINIMALLY INVASIVE TREATMENT APPROACH

10. PATIENT SELECTION AND EVALUATION

11. ADVERSE EFFECTS

12. CONCLUSION

Works Cited

Evidence-Based Practice Recommendations Citations

CADN26X • California Dentists 2026

Mark J. Szarejko, DDS, FAGD

Mark Rose, BS, MA, LP

www.netce.com

Copyright © 2026 NetCE, All rights reserved.

CADN26X • California Dentists 2026

Expiration Date: 03/31/2027

How to Receive Credit

To complete this Special Offer for continuing education credit please go to http://www.netce.com/specials in your browser.

For assistance with receiving continuing education credit, please contact us at help@netce.com.

51294 • The California Dental Practice Act

Mark J. Szarejko, DDS, FAGD

www.netce.com

Copyright © 2025 NetCE, All rights reserved.

Although its primary objective is to safeguard the public, the California Dental Practice Act is an excellent resource for dental professionals to ensure compliance with state law. The California Dental Practice Act is the body of laws in the California Business and Professions Code and the California Code of Regulations governing dental professionals, including dentists, oral and maxillofacial surgeons, orthodontists, dental assistants, and dental hygienists. The Act is intended to serve as a legal guideline for both professionals and the public regarding all aspects of dental practice.

Table of Contents

51294 • The California Dental Practice Act

Course Overview

Audience

Accreditations & Approvals

Designations of Credit

Special Approvals

Course Objective

Learning Objectives

Faculty

Faculty Disclosure

Director of Development and Academic Affairs

Director Disclosure Statement

About the Sponsor

Disclosure Statement

Implicit Bias in Health Care

1. INTRODUCTION

2. DENTISTRY DEFINED: SCOPE OF PRACTICE

DENTISTS

DENTAL ASSISTANTS (UNLICENSED)

REGISTERED DENTAL ASSISTANTS

DENTAL HYGIENISTS

3. LICENSURE

LICENSE RENEWAL

ACTS LEADING TO SUSPENSION OF A LICENSE AND IN VIOLATION OF THE DENTAL PRACTICE ACT

4. VIOLATIONS AND PENALTIES

5. LAWS GOVERNING THE PRESCRIPTION OF DRUGS

6. REPORTING OF ABUSE AND NEGLECT

CHILD ABUSE AND NEGLECT REPORTING LAW

IDENTIFYING, DOCUMENTING, AND REPORTING ABUSE AND NEGLECT

ELDER AND DEPENDENT ADULT ABUSE AND NEGLECT

INTIMATE PARTNER VIOLENCE

7. CONCLUSION

8. RESOURCES

Works Cited

51294 • The California Dental Practice Act

Education Category. Management

Release Date. 02/01/2025

Expiration Date. 01/31/2028

Course Overview

Although its primary objective is to safeguard the public, the California Dental Practice Act is an excellent resource for dental professionals to ensure compliance with state law. The California Dental Practice Act is the body of laws in the California Business and Professions Code and the California Code of Regulations governing dental professionals, including dentists, oral and maxillofacial surgeons, orthodontists, dental assistants, and dental hygienists. The Act is intended to serve as a legal guideline for both professionals and the public regarding all aspects of dental practice.

Audience

This course is designed for all California dentists, dental hygienists, and dental assistants in all practice settings.

Accreditations & Approvals

NetCE Nationally Approved PACE Program Provider for FAGD/MAGD credit. Approval does not imply acceptance by any regulatory authority or AGD endorsement. 10/1/2021 to 9/30/2027 Provider ID #217994. NetCE is an ADA CERP Recognized Provider. ADA CERP is a service of the American Dental Association to assist dental professionals in identifying quality providers of continuing dental education. ADA CERP does not approve or endorse individual courses or instructors, nor does it imply acceptance of credit hours by boards of dentistry. Concerns or complaints about a CE provider may be directed to the provider or to ADA CERP at www.ada.org/cerp. NetCE is approved as a provider of continuing education by the Florida Board of Dentistry, Provider #50-2405. NetCE is a Registered Provider with the Dental Board of California. Provider Number RP3841. Completion of this course does not constitute authorization for the attendee to perform any services that he or she is not legally authorized to perform based on his or her license or permit type. NetCE is accredited by the International Accreditors for Continuing Education and Training (IACET). NetCE complies with the ANSI/IACET Standard, which is recognized internationally as a standard of excellence in instructional practices. As a result of this accreditation, NetCE is authorized to issue the IACET CEU.

Designations of Credit

NetCE designates this activity for 2 continuing education credits. AGD Subject Code 563. This course meets the Dental Board of California's requirements for 2 unit(s) of continuing education. Dental Board of California course #02-3841-26450. NetCE is authorized by IACET to offer 0.2 CEU(s) for this program.

Special Approvals

This course fulfills the California requirement for 2 hours of Dental Practice Act education.

Course Objective

The purpose of this course is to provide California dental professionals with a working knowledge of the contents of the California Dental Practice Act, ensuring that they practice legally and safely.

Learning Objectives

Upon completion of this course, you should be able to:

1. Define the scope of practice of dental professionals in California.

2. Describe the standards of licensure of and medication prescription by dental professionals in California.

3. Identify possible victims of violence or neglect and outline the appropriate response.

Faculty

Mark J. Szarejko, DDS, FAGD, received his dental degree from the State University of New York at Buffalo in 1985. He received fellowship from the Academy of General Dentistry in 1994.

Faculty Disclosure

Contributing faculty, Mark J. Szarejko, DDS, FAGD, has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Director of Development and Academic Affairs

Sarah Campbell

Director Disclosure Statement

The Director of Development and Academic Affairs has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

About the Sponsor

The purpose of NetCE is to provide challenging curricula to assist healthcare professionals to raise their levels of expertise while fulfilling their continuing education requirements, thereby improving the quality of healthcare.

Our contributing faculty members have taken care to ensure that the information and recommendations are accurate and compatible with the standards generally accepted at the time of publication. The publisher disclaims any liability, loss or damage incurred as a consequence, directly or indirectly, of the use and application of any of the contents. Participants are cautioned about the potential risk of using limited knowledge when integrating new techniques into practice.

Disclosure Statement

It is the policy of NetCE not to accept commercial support. Furthermore, commercial interests are prohibited from distributing or providing access to this activity to learners.

Implicit Bias in Health Care

The role of implicit biases on healthcare outcomes has become a concern, as there is some evidence that implicit biases contribute to health disparities, professionals' attitudes toward and interactions with patients, quality of care, diagnoses, and treatment decisions. This may produce differences in help-seeking, diagnoses, and ultimately treatments and interventions. Implicit biases may also unwittingly produce professional behaviors, attitudes, and interactions that reduce patients' trust and comfort with their provider, leading to earlier termination of visits and/or reduced adherence and follow-up. Disadvantaged groups are marginalized in the healthcare system and vulnerable on multiple levels; health professionals' implicit biases can further exacerbate these existing disadvantages.

Interventions or strategies designed to reduce implicit bias may be categorized as change-based or control-based. Change-based interventions focus on reducing or changing cognitive associations underlying implicit biases. These interventions might include challenging stereotypes. Conversely, control-based interventions involve reducing the effects of the implicit bias on the individual's behaviors. These strategies include increasing awareness of biased thoughts and responses. The two types of interventions are not mutually exclusive and may be used synergistically.

1. INTRODUCTION

The California Dental Practice Act is the body of laws in the California Business and Professions Code (CBPC) and the California Code of Regulations (CCR) governing all dental professionals, including dentists, oral and maxillofacial surgeons, orthodontists, unlicensed dental assistants, registered dental assistants, and dental hygienists. The Act is intended to serve as a legal guideline for both professionals and the public regarding all aspects of dental practice. As defined in Section 1016.(b)1 of the CCR, continuing education on the California Dental Practice Act is required and must include instruction on utilization, scope of practice, prescribing laws, violations, citations, fines, licensure, the identification of abuse, and mandatory abuse reporting [1]. Of course, the Act is a much larger volume, so much so that it is beyond the scope of this course to elucidate every section. The Dental Practice Act is not intended to replace professional oaths and codes of ethics but does define actions and omissions that may lead to legal action and revocation of a license to practice dentistry in the State of California, the laws of which are continually evolving.

The Dental Board of California (a division of the California Department of Consumer Affairs), which consists of eight practicing dentists, one registered dental hygienist, one registered dental assistant (each practicing for at least five years), and five public members, is responsible for licensure of qualified dental health professionals, enforcement of the California Dental Practice Act, and improving the education of consumers and licensees [19]. The Board's highest priority is to protect the health and safety of the public.

In addition, the practice of dental hygiene is regulated by the Dental Hygiene Board of California, the first of its kind in the United States [20].

2. DENTISTRY DEFINED: SCOPE OF PRACTICE

According to the American Dental Association, dentistry is defined as "the evaluation, diagnosis, prevention, and treatment of diseases, disorders, and conditions of the oral cavity, the craniomaxillofacial area and the adjacent structures and their impact on the human body. This care is provided by dentists within the scope of their education, training and experience in accordance with the ethics of the profession and applicable law" [2]. The CBPC and the CCR provide specific information regarding utilization and scope of practice for dentists, unlicensed dental assistants, registered dental assistants, and registered dental hygienists, as evidenced in the following sections [1].

DENTISTS

CBPC Section 1625. Dentistry is the diagnosis or treatment, by surgery or other method, of diseases and lesions and the correction of malpositions of the human teeth, alveolar process, gums, jaws, or associated structures; and such diagnosis or treatment may include all necessary related procedures as well as the use of drugs, anesthetic agents, and physical evaluation. Without limiting the foregoing, a person practices dentistry within the meaning of this chapter who does any one or more of the following [24]:

(a) By card, circular, pamphlet, newspaper, Internet website, social media, or in any other way advertises themselves or represents themselves to be a dentist.

(b) Performs, or offers to perform, an operation or diagnosis of any kind, or treats diseases or lesions of the human teeth, alveolar process, gums, jaws, or associated structures, or corrects malposed positions thereof.

(c) In any way indicates that the person will perform by themselves or their agents or servants any operation upon the human teeth, alveolar process, gums, jaws, or associated structures, or in any way indicates that the person will construct, alter, repair, or sell any bridge, crown, denture or other prosthetic appliance or orthodontic appliance.

(d) Makes, or offers to make, an examination of, with the intent to perform or cause to be performed any operation on the human teeth, alveolar process, gums, jaws, or associated structures.

(e) Manages or conducts as manager, proprietor, conductor, lessor, or otherwise, a place where dental operations are performed.

The Board requires that dentists ensure that each patient of record receives a copy of the Dental Materials Fact Sheet (provided by the Board) prior to the placement of his or her first dental restoration [25]. The Dental Materials Fact Sheet details the comparative risks and benefits of available dental restorative materials. The patient must sign an acknowledgment of receipt of the fact sheet, and a copy of the acknowledgment must be placed in the patient's record.

DENTAL ASSISTANTS (UNLICENSED)

Although unlicensed dental assistants are not Board approved, their duties and actions are governed by the Act and they are required to complete coursework in the Dental Practice Act, infection control, and basic life support. Failure to follow the regulations set forth by California law can result in fines and/or imprisonment. As defined in CBPC Section 1750.(a), "A dental assistant is an individual who, without a license, may perform basic supportive dental procedures, as authorized by Section 1750.1 and by regulations adopted by the board, under the supervision of a licensed dentist" [1]. Basic supportive dental procedures are those procedures that have technically elementary characteristics, are completely reversible, and are unlikely to precipitate potentially hazardous conditions for the patient being treated. A licensed dentist is responsible for assuring unlicensed dental assistants' competence and ensuring that they complete required coursework (e.g., two-hour Dental Practice Act, eight-hour infection control, basic life support) and maintain certification in basic life support (if employed for longer than 120 days). Specific duties pertaining to dental assistant practice can be found in CCR Section 1085 [28]. General information regarding regulations pertaining to dental assistants is located in CBPC Sections 1740–1777; although these sections are not discussed in this course, they should be periodically reviewed to ensure self-compliance with the act. The CBPC may include additional duties for various dental assistant professions.

CCR Section 1085. Dental Assistant Duties and Settings.

(a) Unless specifically so provided by regulation, a dental assistant may not perform the following functions or any other activity which represents the practice of dentistry or requires the knowledge, skill and training of a licensed dentist:

1. Diagnosis and treatment planning;

2. Surgical or cutting procedures on hard or soft tissue;

3. Fitting and adjusting of correctional and prosthodontic appliances;

4. Prescription of medicines;

5. Placement, condensation, carving or removal of permanent restorations, including final cementation procedures;

6. Irrigation and medication of canals, try-in cones, reaming, filing or filling of root canals;

7. Taking of impressions for prosthodontic appliances, bridges or any other structures which may be worn in the mouth;

8. Administration of injectable and/or general anesthesia;

9. Oral prophylaxis procedures.

(b) A dental assistant may perform such basic supportive dental procedures as the following under the general supervision of a licensed dentist:

1. Extra-oral duties or functions specified by the supervising dentist;

2. Operation of dental radiographic equipment for the purpose of oral radiography if the dental assistant has complied with the requirements of section 1656 of the Code;

3. Examine orthodontic appliances.

(c) A dental assistant may perform such basic supportive dental procedures as the following under the direct supervision of a licensed dentist when done so pursuant to the order, control and full professional responsibility of the supervising dentist. Such procedures shall be checked and approved by the supervising dentist prior to dismissal of the patient from the office of said dentist.

1. Take impressions for diagnostic and opposing models, bleaching trays, temporary crowns and bridges, and sports guards;

2. Apply non-aerosol and non-caustic topical agents;

3. Remove post-extraction and periodontal dressings;

4. Placement of elastic orthodontic separators;

5. Remove orthodontic separators;

6. Assist in the administration of nitrous oxide analgesia or sedation; however, a dental assistant shall not start the administration of the gases and shall not adjust the flow of the gases unless instructed to do so by the dentist who shall be present at the patient's chairside at the implementation of these instructions. This regulation shall not be construed to prevent any person from taking appropriate action in the event of a medical emergency.

7. Hold anterior matrices;

8. Remove sutures;

9. Take intra-oral measurements for orthodontic procedures;

10. Seat adjusted retainers or headgears, including appropriate instructions;

11. Check for loose bands;

12. Remove arch wires;

13. Remove ligature ties;

14. Apply topical fluoride, after scaling and polishing by the supervising dentist or a registered dental hygienist;

15. Place and remove rubber dams;

16. Place, wedge and remove matrices;

17. Cure restorative or orthodontic materials in operative site with light-curing device.

For the purpose of this section, a supervising licensed dentist is defined as a dentist whose patient is receiving the services of a dental assistant in the treatment facility and is under the direct control of said licensed dentist [1]. Direct supervision is defined as supervision of dental procedures based on instructions given by a licensed dentist who must be physically present in the facility when the procedures are performed.

REGISTERED DENTAL ASSISTANTS

Registered dental assistants (RDAs) are Board-licensed professionals who may perform a greater range of duties than unlicensed dental assistants. Specific information pertaining to RDAs' scope of practice can be found in CCR Section 1086, and general information regarding regulations pertaining to RDAs is located in CBPC Sections 1740–1777, which should be reviewed periodically to ensure self-compliance with the act [28].

CCR Section 1086. RDA Duties and Settings.

(a) Unless specifically so provided by regulation, the prohibitions contained in section 1085 of these regulations apply to registered dental assistants.

(b) A registered dental assistant may perform all functions which may be performed by a dental assistant.

(c) Under general supervision, a registered dental assistant may perform the following duties:

1. Mouth-mirror inspection of the oral cavity, to include charting of obvious lesions, existing restorations and missing teeth;

2. Placement and removal of temporary sedative dressings.

(d) A registered dental assistant may perform the following procedures under the direct supervision of a licensed dentist when done so pursuant to the order, control and full professional responsibility of the supervising dentist. Such procedures shall be checked and approved by the supervising dentist prior to dismissal of the patient from the office of said dentist.

1. Obtain endodontic cultures;

2. Dry canals, previously opened by the supervising dentist, with absorbent points;

3. Test pulp vitality;

4. Place bases and liners on sound dentin;

5. Remove excess cement from supragingival surfaces of teeth with a hand instrument or floss;

6. Size stainless steel crowns, temporary crowns and bands;

7. Fabrication of temporary crowns intra-orally;

8. Temporary cementation and removal of temporary crowns and removal of orthodontic bands;

9. Placement of orthodontic separators;

10. Placement and ligation of arch wires;

11. Placement of post-extraction and periodontal dressings;

12. Apply bleaching agents;

13. Activate bleaching agents with non-laser light-curing device;

14. Take bite registrations for diagnostic models for case study only;

15. Coronal polishing (Evidence of satisfactory completion of a board-approved course of instruction in this function must be submitted to the board prior to any performance thereof).
This procedure shall not be intended or interpreted as a complete oral prophylaxis (a procedure which can be performed only by a licensed dentist or registered dental hygienist). A licensed dentist or registered dental hygienist shall determine that the teeth to be polished are free of calculus or other extraneous material prior to coronal polishing.

16. Removal of excess cement from coronal surfaces of teeth under orthodontic treatment by means of an ultrasonic scaler. (Evidence of satisfactory completion of a board-approved course of instruction or equivalent instruction in an approved RDA program in this function must be submitted to the board prior to any performance thereof.)

(e) Settings. Registered dental assistants may undertake the duties authorized by this section in a treatment facility under the jurisdiction and control of the supervising licensed dentist, or in an equivalent facility approved by the board.

Registered Dental Assistants in Extended Functions

Registered dental assistants in extended functions (RDAEFs) are Board-licensed dental professionals who have a greater breadth of permitted duties than RDAs. Specifics regarding these allowed duties can be found in CCR Section 1087 [28].

CCR Section 1087. RDAEF Duties and Settings.

(a) Unless specifically so provided by regulation, the prohibitions contained in Section 1085 apply to RDAEFs.

(b) An RDAEF may perform all duties assigned to dental assistants and registered dental assistants.

(c) An RDAEF may perform the procedures set forth below under the direct supervision of a licensed dentist when done so pursuant to the order, control and full professional responsibility of the supervising dentist. Such procedures shall be checked and approved by the supervising dentist prior to dismissal of the patient from the office of said dentist.

1. Cord retraction of gingivae for impression procedures;

2. Take impressions for cast restorations;

3. Take impressions for space maintainers, orthodontic appliances, and occlusal guards;

4. Prepare enamel by etching for bonding;

5. Formulate indirect patterns for endodontic post and core castings;

6. Fit trial endodontic filling points;

7. Apply pit and fissure sealants;

8. Remove excess cement from subgingival tooth surfaces with a hand instrument;

9. Apply etchant for bonding restorative materials.

(d) Settings. Registered dental assistants in extended functions may undertake the duties authorized by this section in a treatment facility under the jurisdiction and control of the supervising licensed dentist, or in an equivalent facility approved by the board.

In addition to the duties outlined in CCR section 1087, section 1753.5 of the CBPC states that RDAEFs may conduct preliminary evaluation of the patient's oral health, including, but not limited to, charting, intraoral and extra-oral evaluation of soft tissue, classifying occlusion, and myofunctional evaluation, and perform oral health assessments in school-based, community health project settings under the direction of a dentist, registered dental hygienist, or registered dental hygienist in alternative practice [1]. RDAEFs may hold an orthodontic assistant permit, a dental sedation assistant permit, or both.

DENTAL HYGIENISTS

Registered dental hygienists (RDHs), registered dental hygienists in extended functions (RDHEFs), and registered dental hygienists in alternative practice (RDHAPs) are Board-licensed occupations administered by the Dental Hygiene Committee of California, and the California Dental Practice Act contains the main body of laws and regulations that govern their practice.

The Dental Hygiene Committee of California was created by the Board and consists of seven governor-appointed positions: two public members, four dental hygienists, and one practicing dentist; in addition, there are two public members appointed by the Senate Committee on Rules and the Speaker of the Assembly, respectively [20]. Responsibilities of the Dental Hygiene Committee include adopting regulations; issuing, reviewing, and revoking licenses; developing and administering examinations; determining fees; and updating continuing education requirements for all dental hygiene licensure categories. The Act contains specific information regarding the permitted duties and settings of RDH practice (CCR Section 1088), RDHEF practice (CCR Section 1089), and RDHAP practice (CCR Section 1090) [28]. Additional laws and regulations pertaining specifically to dental hygiene practice are located in CBPC Sections 1900–1966.6. These sections should be periodically reviewed to ensure self-compliance with the Act.

Registered Dental Hygienists

CCR Section 1088. RDH Duties and Settings.

(a) Unless specifically so provided by regulation, the prohibition contained in Section 1085(a), subsections (1) through (8) of these regulations shall apply to duties performed by a registered dental hygienist.

(b) A registered dental hygienist may perform all duties assigned to dental assistants and registered dental assistants, under the supervision of a licensed dentist as specified in these regulations.

(c) Under general supervision, a registered dental hygienist may perform the following duties in addition to those provided by Section 1760(b) of the Code:

1. Root planing;

2. Polish and contour restorations;

3. Oral exfoliative cytology;

4. Apply pit and fissure sealants;

5. Preliminary examination, including but not limited to:

1. Periodontal charting;

2. Intra and extra-oral examination of soft tissue;

3. Charting of lesions, existing restorations and missing teeth;

4. Classifying occlusion;

5. Myofunctional evaluation.

6. Irrigate sub-gingivally with an antimicrobial and/or antibiotic liquid solution(s).

7. The following direct supervision duties of dental assistants and registered dental assistants:

1. Dental Assistant.

1. Taking impressions for diagnostic and opposing models;

2. Applying non-aerosol and non-caustic topical agents;

3. Removing post-extraction and periodontal dressings;

4. Removing sutures;

5. Taking intra-oral measurements for orthodontic procedures;

6. Checking for loose bands;

7. Removing ligature ties;

8. Applying topical fluoride;

9. Placing elastic separators.

2. Registered Dental Assistant

1. Test pulp vitality;

2. Removing excess cement from supragingival surfaces of teeth;

3. Sizing stainless steel crowns, temporary crowns and bands;

4. Temporary cementation and removal of temporary crowns and removal of orthodontic bands;

5. Placing post-extraction and periodontal dressings.

(d) A registered dental hygienist may perform the procedures set forth below under the direct supervision of a licensed dentist when done so pursuant to the order, control and full professional responsibility of the supervising dentist. Such procedures shall be checked and approved by the supervising dentist prior to dismissal of the patient from the office of said dentist.

1. Placement of antimicrobial or antibiotic medicaments which do not later have to be removed;

2. All duties so assigned to a dental assistant or a registered dental assistant, unless otherwise indicated;

3. Periodontal soft tissue curettage (Evidence of satisfactory completion of a board-approved course of instruction in this function must be submitted to the board prior to any performance thereof);

4. Administration of local anesthetic agents, infiltration and conductive, limited to the oral cavity (Evidence of satisfactory completion of a board-approved course of instruction in this function must be submitted to the board prior to any performance thereof);

5. Administration of nitrous oxide and oxygen when used as an analgesic, utilizing fail-safe type machines containing no other general anesthetic agents. (Evidence of satisfactory completion of a board-approved course of instruction in this function must be submitted to the board prior to any performance thereof.)

(e) A registered dental hygienist may undertake the duties authorized by this section in the following settings, provided the appropriate supervision requirements are met:

1. The treatment facility of a licensed dentist;

2. Licensed health facilities as defined in Section 1250 of the Health and Safety Code,

3. Licensed clinics as defined in Section 1203 of the Health and Safety Code,

4. Licensed community care facilities as defined in Section 1502 of the Health and Safety Code,

5. Schools of any grade level whether public or private,

6. Public institutions, including but not limited to federal, state and local penal and correctional facilities.

7. Mobile units operated by a public or governmental agency or a nonprofit and charitable organization approved by the board; provided, however, that the mobile unit meets the statutory and regulatory requirements for mobile units,

8. Home of a non-ambulatory patient, provided there is a written note from a physician or registered nurse stating that the patient is unable to visit a dental office.

9. Health fairs or similar non-profit community activities. Each such fair or activity shall be approved by the board.

Any other facility must be approved by the board.

Registered Dental Hygienists in Extended Functions

CCR Section 1089. RDHEF Duties and Settings.

(a) Unless specifically provided by regulation, the prohibitions contained in Section 1085(a) (1) through (8) shall apply to RDHEFs.

(b) An RDHEF may perform all duties assigned to dental assistants, registered dental assistants and registered dental hygienists.

(c) An RDHEF may perform the procedures set forth below under the direct supervision of a licensed dentist when done so pursuant to the order, control and full professional responsibility of the supervising dentist. Such procedures shall be checked and approved by the supervising dentist prior to dismissal of the patient from the office of said dentist.

1. Cord retraction of gingivae for impression procedures;

2. Take impressions for cast restorations;

3. Take impressions for space maintainers, orthodontic appliances and guards;

4. Prepare enamel by etching for bonding;

5. Formulate indirect patterns for endodontic post and core castings;

6. Fit trial endodontic filling points;

7. Apply etchant for bonding restorative materials.

(d) Settings. Registered dental hygienists in extended functions may undertake the duties authorized by this section in a treatment facility under the jurisdiction and control of the supervising licensed dentist, or an equivalent facility approved by the Board.

Registered Dental Hygienists in Alternative Practice

CCR Section 1090. RDHAP Duties and Settings.

(a) Unless specifically so provided by regulation, an RDHAP may not perform the following functions or any activity which represents the practice of dentistry or requires knowledge, skill and training of a licensed dentist:

1. Diagnosing and treatment planning;

2. Surgical or cutting procedures on hard or soft tissue;

3. Fitting and adjusting of correctional and prosthodontic appliances;

4. Prescribing medication;

5. Placing, condensing, carving or removal of permanent restorations, including final cementation procedures;

6. Irrigating and medicating canals, try-in cones, reaming, filing or filling of root canals;

7. Taking of impressions for prosthodontic appliances, bridges, or any other devices which may be worn in the mouth;

8. Administering local or general anesthesia, oral or parental conscious sedation.

(b) Under the supervision of a licensed dentist, an RDHAP may perform the duties assigned to registered dental hygienists by Section 1088, under the same levels of supervision and in the same settings as specified in that section, in addition to those duties permitted by Section 1768(b)(3).

(c) Independently and without the supervision of a licensed dentist, an RDHAP may, upon the prescription of a dentist or a physician and surgeon licensed in California, perform the duties assigned to a registered dental hygienist by Section 1088(c).

1. All prescriptions shall contain the following information:

1. The pre-printed name, address, license number, and signature of the prescribing dentist or physician and surgeon.

2. The name, address and phone number of the patient.

3. The date the services are prescribed and the expiration date of the prescription. The prescription shall be for dental hygiene services and, if necessary, include special instructions for the care of that patient.

Prior to the establishment of an independent practice, an RDHAP shall provide to the board documentation of an existing relationship with at least one dentist for referral, consultation, and emergency services [1].

3. LICENSURE

All individuals practicing dentistry in California, with the exception of unlicensed dental assistants, must hold a current, valid license issued by the Board; California does not grant reciprocity with other states or nations. The Act requires that dental professionals meet certain education requirements, submit the correct applications and fees, pass the appropriate examinations, and submit a set of fingerprints. Fingerprinting is also required for license renewal if not previously conducted by the California Department of Justice (DOJ) or if records no longer exist [21]. Fingerprinting within California must be conducted using the DOJ Live Scan system; fingerprint records from other institutions (e.g., Department of Motor Vehicles) are not suitable, although ink-on-card fingerprints made at a law enforcement agency are acceptable if unable to travel to California. The required fingerprint cards must be requested from the Dental Board by phone or email [21]. The fingerprints will be used to conduct a criminal history record check and a state and federal level criminal offender record information search.

Issuance, review, and revocation of RDH/RDHEF/RDHAP licenses and the development and administration of license examinations for these auxiliaries are handled by the Dental Hygiene Board of California. All other licensure, including that for RDAs/RDAEFs, is handled by the Dental Board (despite the existence of the Dental Assisting Council, whose purpose is to consider matters related to dental assisting practice and make recommendations to the board). Complaints, investigations, and enforcement are handled by either the Dental Hygiene Board or the Dental Board, according to profession, but the governing regulations and laws set forth in the California Dental Practice Act pertain to all dental professionals. Information about application for licensure to practice as a dentist or dental auxiliary can be found in CCR Section 1028 and CCR Sections 1076–1079.3, respectively. Specific information about the licensure application requirements and process for dentists and dental assistants can be found at https://www.dbc.ca.gov/applicants and for hygienists at https://www.dhbc.ca.gov/applicants.

Effective July 2012, application for licensure may be denied based on delinquent state tax payments [1]. Similarly, current licenses/certifications/registrations may be revoked for failure to pay taxes.

LICENSE RENEWAL

Licenses for all dental professions must be renewed every two years before the last day of the professional's birth month. Practicing without renewing after this date is considered practicing without a license [1]. It is required that dentists have completed 50 hours of continuing education and dental auxiliaries (excluding RDHAPs) have completed 25 hours of continuing education (maximum of 25 hours and 12.5 hours of home study, respectively) upon renewal submission. The continuing education requirement is 35 hours for RDHAPs. Coursework regarding the Dental Practice Act, infection control, and basic life support is mandatory every two years for all licensees. To receive credit, all courses must be from Board-approved providers. In addition, the Board has identified topics that may only constitute a portion of the full continuing education requirement or that are not acceptable at all. A complete listing of allowable and non-allowable courses is available on the Board website.

Links to information regarding license renewal for dentists and dental assistants can be found at https://www.dbc.ca.gov/licensees, and renewal information for hygienists can be found at https://www.dhbc.ca.gov/licensees/renewals.

ACTS LEADING TO SUSPENSION OF A LICENSE AND IN VIOLATION OF THE DENTAL PRACTICE ACT

Violations of the Act by Board licensees are grounds for suspension of a license/certification and are handled by the Board's Enforcement Program, which is composed of five sections: Complaint and Compliance Unit; Inspections/Probation Section; Investigation Unit: Sworn Investigators; Investigation Analysis Unit; and Discipline Coordination Unit [22]. Complaints originate from many sources, including dental professionals, healthcare providers, insurance companies, law enforcement agencies, and patients. Complaint intake specialists route these to the appropriate section; for example, an allegation of an unsafe or unsanitary office condition is routed to the inspection section, whereby Board enforcement inspectors may be sent out and are authorized to issue citations and fines. In addition to Board enforcement action, other law enforcement or regulatory agencies are involved when indicated [1]. Dental professionals placed on probation status by the Board for violations of the Act are monitored by the Enforcement Program's Probation Unit. The Board's Enforcement Unit may be contacted by phone at (916)263-2300 or by e-mail at DentalBoardComplaints@dca.ca,gov. Violations of the Act by hygienists are handled by the Hygiene Board's Complaint Unit, which operates in a similar manner and can be contacted at (866) 810-9899 or by email at DHBCEnforcement@dca.ca.gov.

According to CBPC Section 1670.1, conviction of crimes committed by dental professionals outside of the workplace may also be grounds for Board discipline and can impact licensure status if the crime is "substantially related to the qualifications, functions, or duties of a dentist or dental assistant licensed under this chapter" [1]. These vary considerably on a case-by-case basis. Various lesser convictions, for example, driving under the influence (DUI), illicit drug possession, and prescription drug diversion, may not necessarily lead to license revocation provided the proper steps are taken toward remediation (e.g., entering the Board diversion program, submitting to periodic drug testing) [23]. In general, convictions for assaults, sex crimes, multiple misdemeanors (e.g., second DUI/controlled substance charge), and other egregious violations constitute a basis for denial or revocation of licenses or certifications. In addition to violations outside the workplace, unprofessional conduct, in its many forms, is grounds for Board Enforcement action. Acts and omissions that characterize unprofessional conduct are covered extensively in CBPC Sections 1680, 1681, and 1682 and CCR Section 1018.05.

CBPC Section 1680. Unprofessional conduct by a person licensed under this chapter is defined as, but is not limited to, any one of the following:

(a) The obtaining of any fee by fraud or misrepresentation.

(b) The employment directly or indirectly of any student or suspended or unlicensed dentist to practice dentistry as defined in this chapter.

(c) The aiding or abetting of any unlicensed person to practice dentistry.

(d) The aiding or abetting of a licensed person to practice dentistry unlawfully.

(e) The committing of any act or acts of sexual abuse, misconduct, or relations with a patient that are substantially related to the practice of dentistry.

(f) The use of any false, assumed, or fictitious name, either as an individual, firm, corporation, or otherwise, or any name other than the name under which the person is licensed to practice, in advertising or in any other manner indicating that the person is practicing or will practice dentistry, except that name as is specified in a valid permit issued pursuant to Section 1701.5.

(g) The practice of accepting or receiving any commission or the rebating in any form or manner of fees for professional services, radiograms, prescriptions, or other services or articles supplied to patients.

(h) The making use by the licensee or any agent of the licensee of any advertising statements of a character tending to deceive or mislead the public.

(i) The advertising of either professional superiority or the advertising of performance of professional services in a superior manner. This subdivision shall not prohibit advertising permitted by subdivision (h) of Section 651.

(j) The employing or the making use of solicitors.

(k) The advertising in violation of Section 651.

(l) The advertising to guarantee any dental service, or to perform any dental operation painlessly. This subdivision shall not prohibit advertising permitted by Section 651.

(m) The violation of any of the provisions of law regulating the procurement, dispensing, or administration of dangerous drugs, as defined in Chapter 9 (commencing with Section 4000) or controlled substances, as defined in Division 10 (commencing with Section 11000) of the Health and Safety Code.

(n) The violation of any of the provisions of this division.

(o) The permitting of any person to operate dental radiographic equipment who has not met the requirements of Section 1656.

(p) The clearly excessive prescribing or administering of drugs or treatment, or the clearly excessive use of diagnostic procedures, or the clearly excessive use of diagnostic or treatment facilities, as determined by the customary practice and standards of the dental profession. Any person who violates this subdivision is guilty of a misdemeanor and shall be punished by a fine of not less than one hundred dollars ($100) or more than six hundred dollars ($600), or by imprisonment for a term of not less than 60 days or more than 180 days, or by both a fine and imprisonment.

(q) The use of threats or harassment against any patient or licensee for providing evidence in any possible or actual disciplinary action, or other legal action; or the discharge of an employee primarily based on the employee's attempt to comply with the provisions of this chapter or to aid in the compliance.

(r) Suspension or revocation of a license issued, or discipline imposed, by another state or territory on grounds that would be the basis of discipline in this state.

(s) The alteration of a patient's record with intent to deceive.

(t) Unsanitary or unsafe office conditions, as determined by the customary practice and standards of the dental profession.

(u) The abandonment of the patient by the licensee, without written notice to the patient that treatment is to be discontinued and before the patient has ample opportunity to secure the services of another dentist, registered dental hygienist, registered dental hygienist in alternative practice, or registered dental hygienist in extended functions and provided the health of the patient is not jeopardized.

(v) The willful misrepresentation of facts relating to a disciplinary action to the patients of a disciplined licensee.

(w) Use of fraud in the procurement of any license issued pursuant to this chapter.

(x) Any action or conduct that would have warranted the denial of the license.

(y) The aiding or abetting of a licensed dentist, dental assistant, registered dental assistant, registered dental assistant in extended functions, dental sedation assistant permitholder, orthodontic assistant permitholder, registered dental hygienist, registered dental hygienist in alternative practice, or registered dental hygienist in extended functions to practice dentistry in a negligent or incompetent manner.

(z)

1. The failure to report to the board in writing within seven days any of the following:

1. the death of the licensee's patient during the performance of any dental or dental hygiene procedure;

2. the discovery of the death of a patient whose death is related to a dental or dental hygiene procedure performed by the licensee; or

3. except for a scheduled hospitalization, the removal to a hospital or emergency center for medical treatment of any patient to whom oral conscious sedation, conscious sedation, or general anesthesia was administered, or any patient as a result of dental or dental hygiene treatment. With the exception of patients to whom oral conscious sedation, conscious sedation, or general anesthesia was administered, removal to a hospital or emergency center that is the normal or expected treatment for the underlying dental condition is not required to be reported. Upon receipt of a report pursuant to this subdivision the board may conduct an inspection of the dental office if the board finds that it is necessary. A dentist shall report to the board all deaths occurring in the licensee's practice with a copy sent to the Dental Hygiene Board of California if the death was the result of treatment by a registered dental hygienist, registered dental hygienist in alternative practice, or registered dental hygienist in extended functions. A registered dental hygienist, registered dental hygienist in alternative practice, or registered dental hygienist in extended functions shall report to the Dental Hygiene Board of California all deaths occurring as the result of dental hygiene treatment, and a copy of the notification shall be sent to the board.

2. The report required by this subdivision shall be on a form or forms approved by the board. The form or forms approved by the board shall require the licensee to include, but not be limited to, the following information for cases in which patients received anesthesia: the date of the procedure; the patient's age in years and months, weight, and sex; the patient's American Society of Anesthesiologists (ASA) physical status; the patient's primary diagnosis; the patient's coexisting diagnoses; the procedures performed; the sedation setting; the medications used; the monitoring equipment used; the category of the provider responsible for sedation oversight; the category of the provider delivering sedation; the category of the provider monitoring the patient during sedation; whether the person supervising the sedation performed one or more of the procedures; the planned airway management; the planned depth of sedation; the complications that occurred; a description of what was unexpected about the airway management; whether there was transportation of the patient during sedation; the category of the provider conducting resuscitation measures; and the resuscitation equipment utilized. Disclosure of individually identifiable patient information shall be consistent with applicable law. A report required by this subdivision shall not be admissible in any action brought by a patient of the licensee providing the report.

3. For the purposes of paragraph (2), categories of provider are: General Dentist, Pediatric Dentist, Oral Surgeon, Dentist Anesthesiologist, Physician Anesthesiologist, Dental Assistant, Registered Dental Assistant, Dental Sedation Assistant, Registered Nurse, Certified Registered Nurse Anesthetist, or Other.

4. The form shall state that this information shall not be considered an admission of guilt, but is for educational, data, or investigative purposes.

5. The board may assess a penalty on any licensee who fails to report an instance of an adverse event as required by this subdivision. The licensee may dispute the failure to file within 10 days of receiving notice that the board had assessed a penalty against the licensee.

(aa) Participating in or operating any group advertising and referral services that are in violation of Section 650.2.

(ab) The failure to use a fail-safe machine with an appropriate exhaust system in the administration of nitrous oxide. The board shall, by regulation, define what constitutes a fail-safe machine.

(ac) Engaging in the practice of dentistry with an expired license.

(ad) Except for good cause, the knowing failure to protect patients by failing to follow infection control guidelines of the board, thereby risking transmission of bloodborne infectious diseases from dentist, dental assistant, registered dental assistant, registered dental assistant in extended functions, dental sedation assistant permitholder, orthodontic assistant permitholder, registered dental hygienist, registered dental hygienist in alternative practice, or registered dental hygienist in extended functions to patient, from patient to patient, and from patient to dentist, dental assistant, registered dental assistant, registered dental assistant in extended functions, dental sedation assistant permitholder, orthodontic assistant permitholder, registered dental hygienist, registered dental hygienist in alternative practice, or registered dental hygienist in extended functions. In administering this subdivision, the board shall consider referencing the standards, regulations, and guidelines of the State Department of Public Health developed pursuant to Section 1250.11 of the Health and Safety Code and the standards, guidelines, and regulations pursuant to the California Occupational Safety and Health Act of 1973 (Part 1 (commencing with Section 6300) of Division 5 of the Labor Code) for preventing the transmission of HIV, hepatitis B, and other blood-borne pathogens in health care settings. The board shall review infection control guidelines, if necessary, on an annual basis and proposed changes shall be reviewed by the Dental Hygiene Board of California to establish a consensus. The Board shall submit any recommended changes to the infection control guidelines for review to establish a consensus. As necessary, the board shall consult with the Medical Board of California, the California Board of Podiatric Medicine, the Board of Registered Nursing, and the Board of Vocational Nursing and Psychiatric Technicians, to encourage appropriate consistency in the implementation of this subdivision.

The board shall seek to ensure that all appropriate dental personnel are informed of the responsibility to follow infection control guidelines, and of the most recent scientifically recognized safeguards for minimizing the risk of transmission of bloodborne infectious diseases.

(ae) The utilization by a licensed dentist of any person to perform the functions of any registered dental assistant, registered dental assistant in extended functions, dental sedation assistant permitholder, orthodontic assistant permitholder, registered dental hygienist, registered dental hygienist in alternative practice, or registered dental hygienist in extended functions who, at the time of initial employment, does not possess a current, valid license or permit to perform those functions.

(af) The prescribing, dispensing, or furnishing of dangerous drugs or devices, as defined in Section 4022, in violation of Section 2242.1.

(ag) Using water, or other methods used for irrigation, that are not sterile or that do not contain recognized disinfecting or antibacterial properties when performing dental procedures on exposed dental pulp.

(ah) The failure by the treating dentist, prior to the initial diagnosis and correction of malpositions of human teeth or initial use of orthodontic appliances, to perform an examination pursuant to subdivision (b) of Section 1684.5, including the review of the patient's most recent diagnostic digital or conventional radiographs or other equivalent bone imaging suitable for orthodontia. New radiographs or other equivalent bone imaging shall be ordered if deemed appropriate by the treating dentist.

Section 1681. In addition to other acts constituting unprofessional conduct within the meaning of this chapter, it is unprofessional conduct for a person licensed under this chapter to do any of the following:

(a) Obtain or possess in violation of law, or except as directed by a licensed physician and surgeon, dentist, or podiatrist, administer to himself, any controlled substance, as defined in Division 10 (commencing with Section 11000) of the Health and Safety Code, or any dangerous drug as defined in Article 8 (commencing with Section 4211) of Chapter 9.

(b) Use any controlled substance, as defined in Division 10 (commencing with Section 11000) of the Health and Safety Code, or any dangerous drug as defined in Article 8 (commencing with Section 4211) of Chapter 9, or alcoholic beverages or other intoxicating substances, to an extent or in a manner dangerous or injurious to himself, to any person, or the public to the extent that such use impairs his ability to conduct with safety to the public the practice authorized by his license.

(c) The conviction of a charge of violating any federal statute or rules, or any statute or rule of this state, regulating controlled substances, as defined in Division 10 (commencing with Section 11000) of the Health and Safety Code, or any dangerous drug, as defined in Article 8 (commencing with Section 4211) of Chapter 9, or the conviction of more than one misdemeanor, or any felony, involving the use or consumption of alcohol or drugs, if the conviction is substantially related to the practice authorized by his license. The record of conviction or certified copy thereof, certified by the clerk of the court or by the judge in whose court the conviction is had, shall be conclusive evidence of a violation of this section; a plea or verdict of guilty or a conviction following a plea of nolo contendere is deemed to be a conviction within the meaning of this section; the board may order the license suspended or revoked, or may decline to issue a license, when the time for appeal has elapsed or the judgment of conviction has been affirmed on appeal, or when an order granting probation is made suspending imposition of sentence, irrespective of a subsequent order under any provision of the Penal Code, including, but not limited to, Section 1203.4 of the Penal Code, allowing such person to withdraw his plea of guilty and to enter a plea of not guilty, or setting aside the verdict of guilty, or dismissing the accusation, information or indictment.

Section 1682. In addition to other acts constituting unprofessional conduct under this chapter, it is unprofessional conduct for:

(a) Any dentist performing dental procedures to have more than one patient undergoing moderate sedation, deep sedation, or general anesthesia on an outpatient basis at any given time unless each patient is being continuously monitored on a one-to-one ratio while sedated by either the dentist or another licensed health professional authorized by law to administer moderate sedation, deep sedation, or general anesthesia.

(b) Any dentist with patients recovering from moderate sedation, deep sedation, or general anesthesia to fail to have the patients closely monitored by licensed health professionals experienced in the care and resuscitation of patients recovering from moderate sedation, deep sedation, or general anesthesia. If one licensed professional is responsible for the recovery care of more than one patient at a time, all of the patients shall be physically in the same room to allow continuous visual contact with all patients and the patient to recovery staff ratio should not exceed three to one.

(c) Any dentist with patients who are undergoing deep sedation, general anesthesia, or moderate sedation to fail to have these patients continuously monitored during the dental procedure with a pulse oximeter or similar or superior monitoring equipment and ventilation continuously monitored using at least two of the three following methods:

1. Auscultation of breath sounds using a precordial stethoscope.

2. Monitoring for the presence of exhaled carbon dioxide with capnography.

3. Verbal communication with a patient under moderate sedation. This method shall not be used for a patient under deep sedation or general anesthesia.

(d) Any dentist with patients who are undergoing moderate sedation to have dental office personnel directly involved with the care of those patients who are not certified in basic cardiac life support (CPR) and recertified biennially.

(e)

1. Any dentist to fail to obtain the written informed consent of a patient prior to administering moderate sedation, deep sedation, general anesthesia. In the case of a minor, the consent shall be obtained from the child's parent or guardian.

2. The written informed consent for general anesthesia, in the case of a minor, shall include, but not be limited to, the following information:
"The administration and monitoring of deep sedation or general anesthesia may vary depending on the type of procedure, the type of practitioner, the age and health of the patient, and the setting in which anesthesia is provided. Risks may vary with each specific situation. You are encouraged to explore all the options available for your child's anesthesia for their dental treatment, and consult with your dentist, family physician, or pediatrician as needed."

3. Nothing in this subdivision shall be construed to establish the reasonable standard of care for administering or monitoring oral moderate sedation, moderate sedation, deep sedation, or general anesthesia.

Section 1683. (a) Every dentist, dental health professional, or other licensed health professional who performs a service on a patient in a dental office shall identify himself or herself in the patient record by signing his or her name, or an identification number and initials, next to the service performed and shall date those treatment entries in the record. Any person licensed under this chapter who owns, operates, or manages a dental office shall ensure compliance with this requirement.

(b) Repeated violations of this section constitute unprofessional conduct.

Section 1683.1 (a) Any individual, partnership, corporation, or other entity that provides dental services through telehealth shall make available the name, telephone number, practice address, and California state license number of any dentist who will be involved in the provision of services to a patient prior to the rendering of services and when requested by a patient.

(b) A violation of this section shall constitute unprofessional conduct.

Section 1684. In addition to other acts constituting unprofessional conduct under this chapter, it is unprofessional conduct for a person licensed under this chapter to perform, or hold himself or herself out as able to perform, professional services beyond the scope of his or her license and field or fields of competence as established by his or her education, experience, training, or any combination thereof. This includes, but is not limited to, the use of any instrument or device in a manner that is not in accordance with the customary standards and practices of the dental profession. This section shall not apply to research conducted by accredited dental schools or colleges, or to research conducted pursuant to an investigational device exemption issued by the United States Food and Drug Administration.

(a)

1. A licensee who fails or refuses to comply with a request for the dental records of a patient, that is accompanied by written authorization of the patient or the patient’s representative, as defined in subdivision (e) of Section 123105 of the Health and Safety Code, for release of record to the board, within 15 days of receiving the request and authorization, shall pay to the board a civil penalty of two hundred fifty dollars ($250) per day for each day that the documents have not been produced after the 15th day, up to a maximum of five thousand dollars ($5,000) unless the licensee is unable to provide the documents within this time period for good cause.

2. A health care facility shall comply with a request for the dental records of a patient that is accompanied by that patient’s written authorization for release of records to the board together with a notice citing this section and describing the penalties for failure to comply with this section. Failure to provide the patient’s dental records to the board within 30 days of receiving this request, authorization, and notice shall subject the health care facility to a civil penalty, payable to the board, of up to two hundred fifty dollars ($250) per day for each day that the documents have not been produced after the 30th day, up to a maximum of five thousand dollars ($5,000), unless the health care facility is unable to provide the documents within this time period for good cause. This paragraph shall not require health care facilities to assist the board in obtaining the patient’s authorization. The board shall pay the reasonable cost of copying the dental records.

(b)

1. A licensee who fails or refuses to comply with a court order, issued in the enforcement of a subpoena, mandating the release of records to the board shall pay to the board a civil penalty of one thousand dollars ($1,000) per day for each day that the documents have not been produced after the date by which the court order requires the documents to be produced, unless it is determined that the order is unlawful or invalid. Any statute of limitations applicable to the filing of an accusation by the board shall be tolled during the period the licensee is out of compliance with the court order and during any related appeals.

2. Any licensee who fails or refuses to comply with a court order, issued in the enforcement of a subpoena, mandating the release of records to the board is guilty of a misdemeanor punishable by a fine payable to the board not to exceed five thousand dollars ($5,000). The fine shall be added to the licensee’s renewal fee if it is not paid by the next succeeding renewal date. Any statute of limitations applicable to the filing of an accusation by the board shall be tolled during the period the licensee is out of compliance with the court order and during any related appeals.

3. A health care facility that fails or refuses to comply with a court order, issued in the enforcement of a subpoena, mandating the release of patient records to the board, that is accompanied by a notice citing this section and describing the penalties for failure to comply with this section, shall pay to the board a civil penalty of up to one thousand dollars ($1,000) per day for each day that the documents have not been produced, up to ten thousand dollars ($10,000), after the date by which the court order requires the documents to be produced, unless it is determined that the order is unlawful or invalid. Any statute of limitations applicable to the filing of an accusation by the board against a licensee shall be tolled during the period the health care facility is out of compliance with the court order and during any related appeals.

4. Any health care facility that fails or refuses to comply with a court order, issued in the enforcement of a subpoena, mandating the release of records to the board is guilty of a misdemeanor punishable by a fine payable to the board not to exceed five thousand dollars ($5,000). Any statute of limitations applicable to the filing of an accusation by the board against a licensee shall be tolled during the period the health care facility is out of compliance with the court order and during any related appeals.

(c) Multiple acts by a licensee in violation of subdivision (b) shall be punishable by a fine not to exceed five thousand dollars ($5,000) or by imprisonment in a county jail not exceeding six months, or by both that fine and imprisonment. Multiple acts by a health care facility in violation of subdivision (b) shall be punishable by a fine not to exceed five thousand dollars ($5,000) and shall be reported to the State Department of Health Care Services and shall be considered as grounds for disciplinary action with respect to licensure, including suspension or revocation of the license or certificate.

(d) A failure or refusal to comply with a court order, issued in the enforcement of a subpoena, mandating the release of records to the board constitutes unprofessional conduct and is grounds for suspension or revocation of the licensee’s license.

(e) Imposition of the civil penalties authorized by this section shall be in accordance with the Administrative Procedure Act (Chapter 5 (commencing with Section 11500) of Division 3 of Title 2 of the Government Code).

(f) For the purposes of this section, a “health care facility” means a clinic or health care facility licensed or exempt from licensure pursuant to Division 2 (commencing with Section 1200) of the Health and Safety Code.

1684.5. (a) In addition to other acts constituting unprofessional conduct under this chapter, it is unprofessional conduct for any dentist to perform or allow to be performed any treatment on a patient who is not a patient of record of that dentist. A dentist may, however, after conducting a preliminary oral examination, require or permit any dental auxiliary to perform procedures necessary for diagnostic purposes, provided that the procedures are permitted under the auxiliary's authorized scope of practice. Additionally, a dentist may require or permit a dental auxiliary to perform all of the following duties prior to any examination of the patient by the dentist, provided that the duties are authorized for the particular classification of dental auxiliary pursuant to Article 7 (commencing with Section 1740):

1. Expose emergency radiographs upon direction of the dentist.

2. If the dental auxiliary is a registered dental assistant in extended functions, a registered dental hygienist, or a registered dental hygienist in alternative practice, determine and perform radiographs for the specific purpose of aiding a dentist in completing a comprehensive diagnosis and treatment plan for a patient using telehealth, as defined by Section 2290.5, for the purpose of communication with the supervising dentist pursuant to Sections 1753.55, 1910.5, and 1926.05. A dentist is not required to review patient records or make a diagnosis using telehealth.

3. Perform extra-oral duties or functions specified by the dentist.

4. Perform mouth-mirror inspections of the oral cavity, to include charting of obvious lesions, malocclusions, existing restorations, and missing teeth.

(b) For purposes of this section, "patient of record" refers to a patient who has been examined, has had a medical and dental history completed and evaluated, and has had oral conditions diagnosed and a written plan developed by the licensed dentist.

(c) For purposes of this section, if dental treatment is provided to a patient by a registered dental assistant in extended functions, a registered dental hygienist, or a registered dental hygienist in alternative practice pursuant to the diagnosis and treatment plan authorized by a supervising dentist, at a location other than the dentist's practice location, it is the responsibility of the authorizing dentist that the patient or the patient's representative receive written notification that the care was provided at the direction of the authorizing dentist and that the notification include the authorizing dentist's name, practice location address, and telephone number. This provision shall not require patient notification for dental hygiene preventive services provided in public health programs as specified and authorized in Section 1911, or for dental hygiene care when provided as specified and authorized in Section 1926.

(d) A dentist shall not concurrently supervise more than a total of five registered dental assistants in extended functions, registered dental hygienists, or registered dental hygienists in alternative practice providing services pursuant to Sections 1753.55, 1910.5, and 1926.05.

(e) This section shall not apply to dentists providing examinations on a temporary basis outside of a dental office in settings including, but not limited to, health fairs and school screenings.

(f) This section shall not apply to fluoride mouth rinse or supplement programs administered in a school or preschool setting.

Section 1685. In addition to other acts constituting unprofessional conduct under this chapter, it is unprofessional conduct for a person licensed under this chapter to require, either directly or through an office policy, or knowingly permit the delivery of dental care that discourages necessary treatment or permits clearly excessive treatment, incompetent treatment, grossly negligent treatment, repeated negligent acts, or unnecessary treatment, as determined by the standard of practice in the community.

CCR Section 1018.05 Unprofessional Conduct Defined. In addition to those acts detailed in Business and Professions Code Sections 1670, 1680, 1681 and 1682, the following shall also constitute unprofessional conduct:

(a) Failure to provide records requested by the Board within 15 days of the date of receipt of the request or within the time specified in the request, whichever is later, unless the licensee is unable to provide the documents within this time period for good cause. For the purposes of this section, "good cause" includes physical inability to access the records in the time allowed due to illness or travel.

(b) Failure to report to the Board, within 30 days, any of the following:

1. The bringing of an indictment or information charging a felony against the licensee.

2. The conviction of the licensee, including any verdict of guilty, or pleas of guilty or no contest, of any felony or misdemeanor.

3. Any disciplinary action taken by another professional licensing entity or authority of this state or of another state or an agency of the federal government or the United States military.

4. For the purposes of this section, "conviction" means a plea or verdict of guilty or a conviction following a plea of nolo contendere or "no contest" and any conviction that has been set aside or deferred pursuant to Sections 1000 or 1203.4 of the Penal Code, including infractions, misdemeanors, and felonies. "Conviction" does not include traffic infractions with a fine of less than one thousand dollars ($1,000) unless the infraction involved alcohol or controlled substances.

4. VIOLATIONS AND PENALTIES

As discussed, various acts or omissions can be cause for revocation or suspension of a license. Violation of any section of the Dental Practice Act can also lead to civil and criminal prosecution, including [1]:

Section 1700. Any person, company, or association is guilty of a misdemeanor, and upon conviction thereof shall be punished by imprisonment in the county jail not less than 10 days nor more than one year, or by a fine of not less than one hundred dollars ($100) nor more than one thousand five hundred dollars ($1,500), or by both fine and imprisonment, who:

(a) Assumes the degree of "doctor of dental surgery," "doctor of dental science," or "doctor of dental medicine" or appends the letters "DDS," or "DDSc" or "DMD" to his or her name without having had the right to assume the title conferred upon him or her by diploma from a recognized dental college or school legally empowered to confer the same.

(b) Assumes any title, or appends any letters to his or her name, with the intent to represent falsely that he or she has received a dental degree or license.

(c) Engages in the practice of dentistry without causing to be displayed in an area that is likely to be seen by all patients who use the facility, the original or copy of the current license, permit, or registration of each person employed at the facility to practice dentistry.

(d) Within 10 days after demand is made by the executive officer of the board, fails to furnish to the board the name and address of all persons practicing or assisting in the practice of dentistry in the office of the person, company, or association, at any time within 60 days prior to the demand, together with a sworn statement showing under and by what license or authority this person, company, or association and any employees are or have been practicing dentistry. This sworn statement shall not be used in any prosecution under this section.

(e) Is under the influence of alcohol or a controlled substance while engaged in the practice of dentistry in actual attendance on patients to an extent that impairs his or her ability to conduct the practice of dentistry with safety to patients and the public.

Section 1700.5. Notwithstanding Section 1700, any person who holds a valid, unrevoked, and unsuspended certificate as a dentist under this chapter may append the letters "DDS" to his or her name, regardless of the degree conferred upon him or her by the dental college from which the licensee graduated.

Section 1701. (a) Any person is for the first offense guilty of a misdemeanor and shall be punishable by a fine of not less than two hundred dollars ($200) or more than three thousand dollars ($3,000), or by imprisonment in a county jail for not to exceed six months, or both, and for the second or a subsequent offense is guilty of a felony and upon conviction thereof shall be punished by a fine of not less than two thousand dollars ($2,000) nor more than six thousand dollars ($6,000), or by imprisonment pursuant to subdivision (h) of Section 1170 of the Penal Code, or by both such fine and imprisonment, who:

1. Sells or barters or offers to sell or barter any dental degree or any license or transcript made or purporting to be made pursuant to the laws regulating the license and registration of dentists.

2. Purchases or procures by barter any such diploma, license or transcript with intent that the same shall be used in evidence of the holder's qualification to practice dentistry, or in fraud of the laws regulating such practice.

3. With fraudulent intent, makes or attempts to make, counterfeits or alters in a material regard any such diploma, certificate or transcript.

4. Uses, attempts or causes to be used, any such diploma, certificate or transcript which has been purchased, fraudulently issued, counterfeited or materially altered, either as a license to practice dentistry, or in order to procure registration as a dentist.

5. In an affidavit, required of an applicant for examination, license or registration under this chapter, willfully makes a false statement in a material regard.

6. Practices dentistry or offers to practice dentistry as it is defined in this chapter, either without a license, or when his license has been revoked or suspended.

7. Under any false, assumed or fictitious name, either as an individual, firm, corporation or otherwise, or any name other than the name under which he is licensed, practices, advertises or in any other manner indicates that he is practicing or will practice dentistry, except such name as is specified in a valid permit issued pursuant to Section 1701.5.

(b) The board may post an administrative citation issued pursuant to Section 148 on the board's internet website for an offense described in subdivision (a).

Section 1701.1. (a) Notwithstanding Sections 1700 and 1701, a person who willfully, under circumstances or conditions that cause or create risk of bodily harm, serious physical or mental illness, or death, practices or attempts to practice, or advertises or holds himself or herself out as practicing dentistry without having at the time of so doing a valid, unrevoked, and unsuspended certificate, license, registration, or permit as provided in this chapter, or without being authorized to perform that act pursuant to a certificate, license, registration, or permit obtained in accordance with some other provision of law, is guilty of a public offense, punishable by a fine not exceeding ten thousand dollars ($10,000), by imprisonment pursuant to subdivision (h) of Section 1170 of the Penal Code, by imprisonment in a county jail not exceeding one year, or by both the fine and either imprisonment.

(b) A person who conspires with or aids and abets another to commit any act described in subdivision (a) is guilty of a public offense and subject to the punishment described in subdivision (a).

(c) The board may post an administrative citation issued pursuant to Section 148 on the board's internet website for an offense described in subdivisions (a) and (b).

(d) The remedy provided in this section shall not preclude any other remedy provided by law.

5. LAWS GOVERNING THE PRESCRIPTION OF DRUGS

The California Dental Practice Act states that only doctors of dentistry are permitted to prescribe drugs, including analgesics, sedatives, and antibiotics, although prescription of oral conscious sedation to children younger than 13 years of age requires a permit. Dental assistants and dental hygienists are not permitted to write prescriptions [1]. There are many federal and state laws and regulations pertaining to prescribing. It is the responsibility of each Drug Enforcement Administration (DEA)-registered prescriber (or those exempted) to be familiar with and maintain knowledge of all applicable laws and regulations. Pertinent citations of federal laws governing the prescription of controlled substances are included in the DEA Practitioner's Manual, available at https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-071)(EO-DEA226)_Practitioner's_Manual_(final).pdf. The California Uniform Controlled Substances Act (part of the California Health and Safety Code) can be found at https://leginfo.legislature.ca.gov/faces/codes_displayexpandedbranch.xhtml?tocCode=HSC&division=10.&title=&part=&chapter=&article. The Substances Act begins at Section 11000, and information regarding prescriptions begins in Section 11150.

There must be careful consideration when prescribing to addicts or suspected addicts, particularly when patients are requesting specific drugs. As of 2016, California legislation requires that all prescribers of controlled substances register to access CURES, the state prescription drug monitoring program database intended to aid prescribers and dispensers in identifying fraudulent activity, thereby reducing prescription drug abuse and diversion without affecting legitimate medical practice or patient care. As of October 2018, all licensees authorized to prescribe, order, administer, furnish or dispense controlled substances in California must, with some exceptions, check a patient's prescription history in CURES 2.0 before prescribing a Schedule II, III, or IV substance [27].

The following section of the California Business and Professional Code addresses unprofessional conduct related to furnishing prescription drugs and excessive prescribing.

Section 725. (a) Repeated acts of clearly excessive prescribing, furnishing, dispensing, or administering of drugs or treatment, repeated acts of clearly excessive use of diagnostic procedures, or repeated acts of clearly excessive use of diagnostic or treatment facilities as determined by the standard of the community of licensees is unprofessional conduct for a physician and surgeon, dentist, podiatrist, psychologist, physical therapist, chiropractor, optometrist, speech-language pathologist, or audiologist.

(b) Any person who engages in repeated acts of clearly excessive prescribing or administering of drugs or treatment is guilty of a misdemeanor and shall be punished by a fine of not less than one hundred dollars ($100) nor more than six hundred dollars ($600), or by imprisonment for a term of not less than 60 days nor more than 180 days, or by both that fine and imprisonment.

(c) A practitioner who has a medical basis for prescribing, furnishing, dispensing, or administering dangerous drugs or prescription controlled substances shall not be subject to disciplinary action or prosecution under this section.

(d) No physician and surgeon shall be subject to disciplinary action pursuant to this section for treating intractable pain in compliance with Section 2241.5.

The following sections of the Uniform Controlled Substances Act addresses the facilitation of abuse by prescribing practices, including the new CURES reporting requirements.

Section 11150.2. (a) Notwithstanding any other law, if cannabinoids are excluded from Schedule I of the federal Controlled Substances Act and placed on a schedule of the act other than Schedule I, or if a product composed of cannabinoids is approved by the federal Food and Drug Administration and either placed on a schedule of the act other than Schedule I, or exempted from one or more provisions of the act, so as to permit a physician, pharmacist, or other authorized healing arts licensee acting within their scope of practice, to prescribe, furnish, or dispense that product, the physician, pharmacist, or other authorized healing arts licensee who prescribes, furnishes, or dispenses that product in accordance with federal law shall be deemed to be in compliance with state law governing those acts.

(b) For purposes of this chapter, upon the effective date of one of the changes in federal law described in subdivision (a), notwithstanding any other state law, a product composed of cannabinoids may be prescribed, furnished, dispensed, transferred, transported, possessed, or used in accordance with federal law and is authorized pursuant to state law.

(c) This section does not apply to any product containing cannabinoids that is made or derived from industrial hemp, as defined in Section 11018.5 and regulated pursuant to that section.

Section 11153. (a) A prescription for a controlled substance shall only be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. Except as authorized by this division, the following are not legal prescriptions: (1) an order purporting to be a prescription which is issued not in the usual course of professional treatment or in legitimate and authorized research; or (2) an order for an addict or habitual user of controlled substances, which is issued not in the course of professional treatment or as part of an authorized narcotic treatment program, for the purpose of providing the user with controlled substances, sufficient to keep him or her comfortable by maintaining customary use.

(b) Any person who knowingly violates this section shall be punished by imprisonment pursuant to subdivision (h) of Section 1170 of the Penal Code, or in a county jail not exceeding one year, or by a fine not exceeding twenty thousand dollars ($20,000), or by both that fine and imprisonment.

(c) No provision of the amendments to this section enacted during the second year of the 1981–82 Regular Session shall be construed as expanding the scope of practice of a pharmacist.

Section 11164.1. (a)

1. Notwithstanding any other law, a prescription for a controlled substance issued by a prescriber in another state for delivery to a patient in another state may be dispensed by a California pharmacy, if the prescription conforms with the requirements for controlled substance prescriptions in the state in which the controlled substance was prescribed.

2. A prescription for Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances dispensed pursuant to this subdivision shall be reported by the dispensing pharmacy to the Department of Justice in the manner prescribed by subdivision (d) of Section 11165.

(b) A pharmacy may dispense a prescription for a Schedule III, Schedule IV, or Schedule V controlled substance from an out-of-state prescriber pursuant to Section 4005 of the Business and Professions Code and Section 1717 of Title 16 of the California Code of Regulations.

(c) This section shall become operative on January 1, 2021.

Section 11165. (a) To assist health care practitioners in their efforts to ensure appropriate prescribing, ordering, administering, furnishing, and dispensing of controlled substances, law enforcement and regulatory agencies in their efforts to control the diversion and resultant abuse of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances, and for statistical analysis, education, and research, the Department of Justice shall, contingent upon the availability of adequate funds in the CURES Fund, maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of, and Internet access to information regarding, the prescribing and dispensing of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances by all practitioners authorized to prescribe, order, administer, furnish, or dispense these controlled substances.

(b) The Department of Justice may seek and use grant funds to pay the costs incurred by the operation and maintenance of CURES. The department shall annually report to the Legislature and make available to the public the amount and source of funds it receives for support of CURES.

(c)

1. The operation of CURES shall comply with all applicable federal and state privacy and security laws and regulations.

1. CURES shall operate under existing provisions of law to safeguard the privacy and confidentiality of patients. Data obtained from CURES shall only be provided to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the department, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. Data may be provided to public or private entities, as approved by the department, for educational, peer review, statistical, or research purposes, if patient information, including information that may identify the patient, is not compromised. The University of California shall be provided access to identifiable data for research purposes if the requirements of subdivision (t) of Section 1798.24 of the Civil Code are satisfied. Further, data disclosed to an individual or agency as described in this subdivision shall not be disclosed, sold, or transferred to a third party, unless authorized by, or pursuant to, state and federal privacy and security laws and regulations. The department shall establish policies, procedures, and regulations regarding the use, access, evaluation, management, implementation, operation, storage, disclosure, and security of the information within CURES, consistent with this subdivision.

2. Notwithstanding subparagraph (A), a regulatory board whose licensees do not prescribe, order, administer, furnish, or dispense controlled substances shall not be provided data obtained from CURES.

3. The department shall, no later than January 1, 2021, adopt regulations regarding the access and use of the information within CURES. The department shall consult with all stakeholders identified by the department during the rulemaking process. The regulations shall, at a minimum, address all of the following in a manner consistent with this chapter:

1. The process for approving, denying, and disapproving individuals or entities seeking access to information in CURES.

2. The purposes for which a health care practitioner may access information in CURES.

3. The conditions under which a warrant, subpoena, or court order is required for a law enforcement agency to obtain information from CURES as part of a criminal investigation.

4. The process by which information in CURES may be provided for educational, peer review, statistical, or research purposes.

4. In accordance with federal and state privacy laws and regulations, a health care practitioner may provide a patient with a copy of the patient's CURES patient activity report as long as no additional CURES data are provided and the health care practitioner keeps a copy of the report in the patient's medical record in compliance with subdivision (d) of Section 11165.1.

(d) For each prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance, as defined in the controlled substances schedules in federal law and regulations, specifically Sections 1308.12, 1308.13, 1308.14, and 1308.15, respectively, of Title 21 of the Code of Federal Regulations, the dispensing pharmacy, clinic, or other dispenser shall report the following information to the department or contracted prescription data processing vendor as soon as reasonably possible, but not more than one working day after the date a controlled substance is released to the patient or patient's representative, in a format specified by the department:

1. Full name, address, and, if available, telephone number of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services, and the gender, and date of birth of the ultimate user.

2. The prescriber's category of licensure, license number, national provider identifier (NPI) number, if applicable, the federal controlled substance registration number, and the state medical license number of a prescriber using the federal controlled substance registration number of a government-exempt facility.

3. Pharmacy prescription number, license number, NPI number, and federal controlled substance registration number.

4. National Drug Code (NDC) number of the controlled substance dispensed.

5. Quantity of the controlled substance dispensed.

6. The International Statistical Classification of Diseases (ICD) Code contained in the most current ICD revision, or any revision deemed sufficient by the State Board of Pharmacy, if available.

7. Number of refills ordered.

8. Whether the drug was dispensed as a refill of a prescription or as a first-time request.

9. Prescribing date of the prescription.

10. Date of dispensing of the prescription.

11. The serial number for the corresponding prescription form, if applicable.

(e) The department may invite stakeholders to assist, advise, and make recommendations on the establishment of rules and regulations necessary to ensure the proper administration and enforcement of the CURES database. A prescriber or dispenser invitee shall be licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, in active practice in California, and a regular user of CURES.

(f) The department shall, prior to upgrading CURES, consult with prescribers licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, one or more of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, and any other stakeholder identified by the department, for the purpose of identifying desirable capabilities and upgrades to the CURES Prescription Drug Monitoring Program (PDMP).

(g) The department may establish a process to educate authorized subscribers of the CURES PDMP on how to access and use the CURES PDMP.

(h)

1. The department may enter into an agreement with an entity operating an interstate data sharing hub, or an agency operating a prescription drug monitoring program in another state, for purposes of interstate data sharing of prescription drug monitoring program information.

2. Data obtained from CURES may be provided to authorized users of another state's prescription drug monitoring program, as determined by the department pursuant to subdivision (c), if the entity operating the interstate data sharing hub, and the prescription drug monitoring program of that state, as applicable, have entered into an agreement with the department for interstate data sharing of prescription drug monitoring program information.

3. An agreement entered into by the department for purposes of interstate data sharing of prescription drug monitoring program information shall ensure that all access to data obtained from CURES and the handling of data contained within CURES comply with California law, including regulations, and meet the same patient privacy, audit, and data security standards employed and required for direct access to CURES.

4. For purposes of interstate data sharing of CURES information pursuant to this subdivision, an authorized user of another state's prescription drug monitoring program shall not be required to register with CURES, if the authorized user is registered and in good standing with that state's prescription drug monitoring program.

5. The department shall not enter into an agreement pursuant to this subdivision until the department has issued final regulations regarding the access and use of the information within CURES as required by paragraph (3) of subdivision (c).

(j) If the dispensing pharmacy, clinic, or other dispenser experiences a temporary technological or electrical failure, it shall, without undue delay, seek to correct any cause of the temporary technological or electrical failure that is reasonably within its control. The deadline for transmitting prescription information to the department or contracted prescription data processing vendor pursuant to subdivision (d) shall be extended until the failure is corrected. If the dispensing pharmacy, clinic, or other dispenser experiences technological limitations that are not reasonably within its control, or is impacted by a natural or manmade disaster, the deadline for transmitting prescription information to the department or contracted prescription data processing vendor shall be extended until normal operations have resumed.

Section 11165.1. (a)

1. A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 shall, upon receipt of a federal Drug Enforcement Administration (DEA) registration, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to that practitioner or their delegate the electronic history of controlled substances dispensed to an individual under the practitioner's care based on data contained in the CURES Prescription Drug Monitoring Program (PDMP).

2. A pharmacist shall, upon licensure, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the pharmacist or their delegate the electronic history of controlled substances dispensed to an individual under the pharmacist's care based on data contained in the CURES PDMP.

3. A licensed physician and surgeon who does not hold a DEA registration may submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of the patient that is maintained by the department. Upon approval, the department shall release to the physician and surgeon or their delegate the electronic history of controlled substances dispensed to a patient under their care based on data contained in the CURES PDMP.

4. The department shall implement its duties described in clauses (i), (ii), and (iii) upon completion of any technological changes to the CURES database necessary to support clauses (i), (ii), and (iii), or by October 1, 2022, whichever is sooner.

2. The department may deny an application or suspend a subscriber, for reasons that include, but are not limited to, the following:

1. Materially falsifying an application to access information contained in the CURES database.

2. Failing to maintain effective controls for access to the patient activity report.

3. Having their federal DEA registration suspended or revoked.

4. Violating a law governing controlled substances or another law for which the possession or use of a controlled substance is an element of the crime.

5. Accessing information for a reason other than to diagnose or treat a patient, or to document compliance with the law.

3. An authorized subscriber shall notify the department within 30 days of a change to the subscriber account.

4. An approved health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist pursuant to subdivision (b) of Section 209 of the Business and Professions Code may use the department's online portal or a health information technology system that meets the criteria required in subparagraph (E) to access information in the CURES database pursuant to this section. A subscriber who uses a health information technology system that meets the criteria required in subparagraph (E) to access the CURES database may submit automated queries to the CURES database that are triggered by predetermined criteria.

5. An approved health care practitioner or pharmacist may submit queries to the CURES database through a health information technology system if the entity that operates the health information technology system certifies all of the following:

1. The entity will not use or disclose data received from the CURES database for any purpose other than delivering the data to an approved health care practitioner or pharmacist or performing data processing activities that may be necessary to enable the delivery unless authorized by, and pursuant to, state and federal privacy and security laws and regulations.

2. The health information technology system will authenticate the identity of an authorized health care practitioner or pharmacist initiating queries to the CURES database and, at the time of the query to the CURES database, the health information technology system submits the following data regarding the query to CURES:

1. The date of the query.

2. The time of the query.

3. The first and last name of the patient queried.

4. The date of birth of the patient queried.

5. The identification of the CURES user for whom the system is making the query.

3. The health information technology system meets applicable patient privacy and information security requirements of state and federal law.

4. The entity has entered into a memorandum of understanding with the department that solely addresses the technical specifications of the health information technology system to ensure the security of the data in the CURES database and the secure transfer of data from the CURES database. The technical specifications shall be universal for all health information technology systems that establish a method of system integration to retrieve information from the CURES database. The memorandum of understanding shall not govern, or in any way impact or restrict, the use of data received from the CURES database or impose any additional burdens on covered entities in compliance with the regulations promulgated pursuant to the federal Health Insurance Portability and Accountability Act of 1996 found in Parts 160 and 164 of Title 45 of the Code of Federal Regulations.

6. No later than October 1, 2018, the department shall develop a programming interface or other method of system integration to allow health information technology systems that meet the requirements in subparagraph (E) to retrieve information in the CURES database on behalf of an authorized health care practitioner or pharmacist.

7. The department shall not access patient-identifiable information in an entity's health information technology system.

8. An entity that operates a health information technology system that is requesting to establish an integration with the CURES database shall pay a reasonable fee to cover the cost of establishing and maintaining integration with the CURES database.

9. The department may prohibit integration or terminate a health information technology system's ability to retrieve information in the CURES database if the health information technology system fails to meet the requirements of subparagraph (E), or the entity operating the health information technology system does not fulfill its obligation under subparagraph (H).

2. A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 or a pharmacist shall be deemed to have complied with paragraph (1) if the licensed health care practitioner or pharmacist has been approved to access the CURES database through the process developed pursuant to subdivision (a) of Section 209 of the Business and Professions Code.

(b) A request for, or release of, a controlled substance history pursuant to this section shall be made in accordance with guidelines developed by the department.

(c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances, the department may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in CURES to licensed health care practitioners, pharmacists, or both, providing care or services to the individual.

(d) The history of controlled substances dispensed to an individual based on data contained in CURES that is received by a practitioner or pharmacist from the department pursuant to this section is medical information subject to the provisions of the Confidentiality of Medical Information Act contained in Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code.

(e) Information concerning a patient's controlled substance history provided to a practitioner or pharmacist pursuant to this section shall include prescriptions for controlled substances listed in Sections 1308.12, 1308.13, 1308.14, and 1308.15 of Title 21 of the Code of Federal Regulations.

(f) A health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, is not subject to civil or administrative liability arising from false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for a resulting failure of the CURES database to accurately or timely report that information.

(g) For purposes of this section, the following terms have the following meanings:

1. "Automated basis" means using predefined criteria to trigger an automated query to the CURES database, which can be attributed to a specific health care practitioner or pharmacist.

2. "Department" means the Department of Justice.

3. "Entity" means an organization that operates, or provides or makes available, a health information technology system to a health care practitioner or pharmacist.

4. "Health information technology system" means an information processing application using hardware and software for the storage, retrieval, sharing of or use of patient data for communication, decisionmaking, coordination of care, or the quality, safety, or efficiency of the practice of medicine or delivery of health care services, including, but not limited to, electronic medical record applications, health information exchange systems, or other interoperable clinical or health care information system.

(h) This section shall become operative on July 1, 2021, or upon the date the department promulgates regulations to implement this section and posts those regulations on its Internet website, whichever date is earlier.

Section 11165.2. (a) The Department of Justice may conduct audits of the CURES Prescription Drug Monitoring Program system and its users.

(b) The Department of Justice may establish, by regulation, a system for the issuance to a CURES Prescription Drug Monitoring Program subscriber of a citation which may contain an order of abatement, or an order to pay an administrative fine assessed by the Department of Justice if the subscriber is in violation of any provision of this chapter or any regulation adopted by the Department of Justice pursuant to this chapter.

(c) The system shall contain the following provisions:

1. Citations shall be in writing and shall describe with particularity the nature of the violation, including specific reference to the provision of law or regulation of the department determined to have been violated.

2. Whenever appropriate, the citation shall contain an order of abatement establishing a reasonable time for abatement of the violation.

3. In no event shall the administrative fine assessed by the department exceed two thousand five hundred dollars ($2,500) for each violation. In assessing a fine, due consideration shall be given to the appropriateness of the amount of the fine with respect to such factors as the gravity of the violation, the good faith of the subscribers, and the history of previous violations.

4. An order of abatement or a fine assessment issued pursuant to a citation shall inform the subscriber that if the subscriber desires a hearing to contest the finding of a violation, a hearing shall be requested by written notice to the CURES Prescription Drug Monitoring Program within 30 days of the date of issuance of the citation or assessment. Hearings shall be held pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.

5. In addition to requesting a hearing, the subscriber may, within 10 days after service of the citation, request in writing an opportunity for an informal conference with the department regarding the citation. At the conclusion of the informal conference, the department may affirm, modify, or dismiss the citation, including any fine levied or order of abatement issued. The decision shall be deemed to be a final order with regard to the citation issued, including the fine levied or the order of abatement which could include permanent suspension to the system, a monetary fine, or both, depending on the gravity of the violation. However, the subscriber does not waive its right to request a hearing to contest a citation by requesting an informal conference. If the citation is affirmed, a formal hearing may be requested within 30 days of the date the citation was affirmed. If the citation is dismissed after the informal conference, the request for a hearing on the matter of the citation shall be deemed to be withdrawn. If the citation, including any fine levied or order of abatement, is modified, the citation originally issued shall be considered withdrawn and a new citation issued. If a hearing is requested for a subsequent citation, it shall be requested within 30 days of service of that subsequent citation.

6. Failure of a subscriber to pay a fine within 30 days of the date of assessment or comply with an order of abatement within the fixed time, unless the citation is being appealed, may result in disciplinary action taken by the department. If a citation is not contested and a fine is not paid, the subscriber account will be terminated:

1. A citation may be issued without the assessment of an administrative fine.

2. Assessment of administrative fines may be limited to only particular violations of law or department regulations.

(d) Notwithstanding any other provision of law, if a fine is paid to satisfy an assessment based on the finding of a violation, payment of the fine shall be represented as a satisfactory resolution of the matter for purposes of public disclosure.

(e) Administrative fines collected pursuant to this section shall be deposited in the CURES Program Special Fund, available upon appropriation by the Legislature. These special funds shall provide support for costs associated with informal and formal hearings, maintenance, and updates to the CURES Prescription Drug Monitoring Program.

(f) The sanctions authorized under this section shall be separate from, and in addition to, any other administrative, civil, or criminal remedies; however, a criminal action may not be initiated for a specific offense if a citation has been issued pursuant to this section for that offense, and a citation may not be issued pursuant to this section for a specific offense if a criminal action for that offense has been filed.

(g) Nothing in this section shall be deemed to prevent the department from serving and prosecuting an accusation to suspend or revoke a subscriber if grounds for that suspension or revocation exist.

Section 11165.4. (a)

1. A health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance shall consult the patient activity report or information from the patient activity report obtained from the CURES database to review a patient's controlled substance history for the past 12 months before prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient for the first time and at least once every six months thereafter if the prescriber renews the prescription and the substance remains part of the treatment of the patient.

2. If a health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance is not required, pursuant to an exemption described in subdivision (c), to consult the patient activity report from the CURES database the first time the health care practitioner prescribes, orders, administers, or furnishes a controlled substance to a patient, the health care practitioner shall consult the patient activity report from the CURES database to review the patient's controlled substance history before subsequently prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient and at least once every six months thereafter if the prescriber renews the prescription and the substance remains part of the treatment of the patient.

3. A health care practitioner who did not directly access the CURES database to perform the required review of the controlled substance use report shall document in the patient's medical record that they reviewed the CURES database generated report within 24 hours of the controlled substance prescription that was provided to them by another authorized user of the CURES database.

2. For purposes of this paragraph, "first time" means the initial occurrence in which a health care practitioner, in their role as a health care practitioner, intends to prescribe, order, administer, or furnish a Schedule II, Schedule III, or Schedule IV controlled substance to a patient and has not previously prescribed a controlled substance to the patient.

2. A health care practitioner shall review a patient's controlled substance history that has been obtained from the CURES database no earlier than 24 hours, or the previous business day, before the health care practitioner prescribes, orders, administers, or furnishes a Schedule II, Schedule III, or Schedule IV controlled substance to the patient.

(b) The duty to consult the CURES database, as described in subdivision (a), does not apply to veterinarians or pharmacists.

(c) The duty to consult the CURES database, as described in subdivision (a), does not apply to a health care practitioner in any of the following circumstances:

1. If a health care practitioner prescribes, orders, or furnishes a controlled substance to be administered to a patient while the patient in any of the following facilities or during an emergency transfer between any of the following facilities, or for use while on facility premises:

1. A licensed clinic, as described in Chapter 1 (commencing with Section 1200) of Division 2.

2. An outpatient setting, as described in Chapter 1.3 (commencing with Section 1248) of Division 2.

3. A health facility, as described in Chapter 2 (commencing with Section 1250) of Division 2.

4. A county medical facility, as described in Chapter 2.5 (commencing with Section 1440) of Division 2.

5. Another medical facility, including, but not limited to, an office of a health care practitioner and an imaging center.

6. A correctional clinic, as described in Section 4187 of the Business and Professions Code, or a correctional pharmacy, as described in Section 4021.5 of the Business and Professions Code.

2. If a health care practitioner prescribes, orders, administers, or furnishes a controlled substance in the emergency department of a general acute care hospital and the quantity of the controlled substance does not exceed a nonrefillable seven-day supply of the controlled substance to be used in accordance with the directions for use.

3. If a health care practitioner prescribes, orders, administers, or furnishes buprenorphine or other controlled substance containing buprenorphine in the emergency department of a general acute care hospital.

4. If a health care practitioner prescribes, orders, administers, or furnishes a controlled substance to a patient as part of the patient's treatment for a surgical, radiotherapeutic, or diagnostic procedure and the quantity of the controlled substance does not exceed a nonrefillable seven-day supply of the controlled substance to be used in accordance with the directions for use, in any of the following facilities:

1. A licensed clinic, as described in Chapter 1 (commencing with Section 1200) of Division 2.

2. An outpatient setting, as described in Chapter 1.3 (commencing with Section 1248) of Division 2.

3. A health facility, as described in Chapter 2 (commencing with Section 1250) of Division 2.

4. A county medical facility, as described in Chapter 2.5 (commencing with Section 1440) of Division 2.

5. A place of practice, as defined in Section 1658 of the Business and Professions Code.

6. Another medical facility where surgical procedures are permitted to take place, including, but not limited to, the office of a health care practitioner.

5. If a health care practitioner prescribes, orders, administers, or furnishes a controlled substance to a patient who is terminally ill, as defined in subdivision (c) of Section 11159.2.

1. If all of the following circumstances are satisfied:

1. It is not reasonably possible for a health care practitioner to access the information in the CURES database in a timely manner.

2. Another health care practitioner or designee authorized to access the CURES database is not reasonably available.

3. The quantity of controlled substance prescribed, ordered, administered, or furnished does not exceed a nonrefillable seven-day supply of the controlled substance to be used in accordance with the directions for use and no refill of the controlled substance is allowed.

2. A health care practitioner who does not consult the CURES database under subparagraph (A) shall document the reason they did not consult the database in the patient's medical record.

7. If the CURES database is not operational, as determined by the department, or cannot be accessed by a health care practitioner because of a temporary technological or electrical failure. A health care practitioner shall, without undue delay, seek to correct the cause of the temporary technological or electrical failure that is reasonably within the health care practitioner's control.

8. If the CURES database cannot be accessed because of technological limitations that are not reasonably within the control of a health care practitioner.

9. If consultation of the CURES database would, as determined by the health care practitioner, result in a patient's inability to obtain a prescription in a timely manner and thereby adversely impact the patient's medical condition, provided that the quantity of the controlled substance does not exceed a nonrefillable seven-day supply if the controlled substance were used in accordance with the directions for use.

(d)

1. A health care practitioner who fails to consult the CURES database, as described in subdivision (a), shall be referred to the appropriate state professional licensing board solely for administrative sanctions, as deemed appropriate by that board.

2. This section does not create a private cause of action against a health care practitioner. This section does not limit a health care practitioner's liability for the negligent failure to diagnose or treat a patient.

(e) All applicable state and federal privacy laws govern the duties required by this section.

(f) The provisions of this section are severable. If any provision of this section or its application is held invalid, that invalidity shall not affect other provisions or applications that can be given effect without the invalid provision or application.

(g) This section shall become operative on July 1, 2021, or upon the date the department promulgates regulations to implement this section and posts those regulations on its internet website, whichever date is earlier.

6. REPORTING OF ABUSE AND NEGLECT

In accordance with California Penal Code Section 11165.7, dentists, dental assistants, and dental hygienists are mandated reporters of child abuse and neglect [3]. Reporting suspected abuse is not only an ethical duty but is also a legal obligation.

CHILD ABUSE AND NEGLECT REPORTING LAW

Section 11164. (a) This article shall be known and may be cited as the Child Abuse and Neglect Reporting Act.

(b) The intent and purpose of this article is to protect children from abuse and neglect. In any investigation of suspected child abuse or neglect, all persons participating in the investigation of the case shall consider the needs of the child victim and shall do whatever is necessary to prevent psychological harm to the child victim.

Section 11166. (a) Except as provided in subdivision (d), and in Section 11166.05, a mandated reporter shall make a report to an agency specified in Section 11165.9 whenever the mandated reporter, in the mandated reporter's professional capacity or within the scope of the mandated reporter's employment, has knowledge of or observes a child whom the mandated reporter knows or reasonably suspects has been the victim of child abuse or neglect. The mandated reporter shall make an initial report by telephone to the agency immediately or as soon as is practicably possible, and shall prepare and send, fax, or electronically transmit a written follow-up report within 36 hours of receiving the information concerning the incident. The mandated reporter may include with the report any nonprivileged documentary evidence the mandated reporter possesses relating to the incident.

Section 11165.9. Reports of suspected child abuse or neglect shall be made by mandated reporters, or in the case of reports pursuant to Section 11166.05, may be made, to any police department or sheriff's department, not including a school district police or security department, county probation department, if designated by the county to receive mandated reports, or the county welfare department. Any of those agencies shall accept a report of suspected child abuse or neglect whether offered by a mandated reporter or another person, or referred by another agency, even if the agency to whom the report is being made lacks subject matter or geographical jurisdiction to investigate the reported case, unless the agency can immediately electronically transfer the call to an agency with proper jurisdiction. When an agency takes a report about a case of suspected child abuse or neglect in which that agency lacks jurisdiction, the agency shall immediately refer the case by telephone, fax, or electronic transmission to an agency with proper jurisdiction. Agencies that are required to receive reports of suspected child abuse or neglect may not refuse to accept a report of suspected child abuse or neglect from a mandated reporter or another person unless otherwise authorized pursuant to this section, and shall maintain a record of all reports received.

IDENTIFYING, DOCUMENTING, AND REPORTING ABUSE AND NEGLECT

Preventing serious morbidity and mortality involves intervening at the first suspicion or indication of abuse and/or neglect. Dentists and dental hygienists are often the healthcare professionals who have the most frequent interactions with children and should be attentive to any signs of neglect and physical abuse—as abusive injuries commonly involve the face, jaw, mouth, teeth, and tongue [4]. One study found that orofacial trauma was concurrent with 49% of documented cases of child physical abuse [5]. Other studies show that craniofacial and neck injuries occur in 50% to 65% of child abuse victims and that the lips are a site for abusive injury in 54% of cases [6,7].

Clinical Signs of Abuse

The American Academy of Pediatrics (AAP) Committee on Child Abuse and Neglect and the California Dental Association have published useful articles regarding the identification of the orofacial signs of abuse and particular injuries of concern. According to these sources, possible signs of abuse include [6,7,12]:

- Forced feeding injuries caused by eating utensils, bottles, hands, fingers, and other objects; scalding liquids; or caustic substances. These may be responsible for burns, contusions, or lacerations of the lips, tongue, buccal mucosa, gingival alveolar mucosa, frenum, or palate (soft and hard). Objects forced into the face/mouth may also cause facial bone and jaw fractures and avulsed, displaced, or fractured teeth.

- Mouth gagging injuries resulting in bruises, lichenification, or scarring at the corners of the mouth

- Strangulation injuries resulting in bruising, a hoarse or raspy voice, and difficulty breathing

- Discolored teeth from previous trauma

- Serious trauma (e.g., retropharyngeal abscesses, posterior pharyngeal injuries) resulting from caregivers with factitious disorder (i.e., Münchausen syndrome) by proxy

- Injury to the petechiae of the palate (particularly at the junction of soft and hard palate) resulting from forced oral sex

- Sexually transmitted oral/perioral infections (e.g., gonorrhea, human papillomavirus warts), although these can be transmitted by other means as well

- Bite marks or bruises on the head or face, strangulation marks, or black eyes

- Missing hair from hair pulling

- Welts in the shape of objects (e.g., belt buckle, clothes iron)

- Other suspicious trauma/bruises indicative of abuse (e.g., rope marks)

During examination, excessive caries, gingivitis, and oral infections/diseases should be noted as possible signs of neglect. (Parents or caretakers with an ignorance of proper oral care, who have no perceived value of oral health, with limited access to health care or insurance, and/or geographic isolation should be differentiated from those with a willful disregard for the child's health [6].) Perioral and intraoral injuries and infections in various stages of healing, especially those that seem inappropriate for the child's developmental age, should be documented. Additionally, abuse and neglect are more prevalent (up to four times more common) in individuals with developmental or physical disability [12].

Although accidental injuries are common in pediatric patients, the history of trauma, including mechanism and timing, must be weighed against the injury features. Characteristics of the injury that do not seem to match the reported history should spur suspicion of abuse. The acronym RADAR is commonly used to assist in the routine abuse screening of patients [29]:

- Routinely screen for signs and symptoms of abuse/neglect

- Ask direct, non-judgmental questions with compassion

- Document your findings

- Assess patient safety before the patient leaves the medical setting

- Review, refer, report

A parent or primary caretaker may be genuinely unaware of the abuse or injuries and may not be able to offer information relevant to the history. It is important not to make judgments of family members (either innocent or guilty), apportion blame, or attempt to personally undertake a criminal investigation. The scope of dental practice does not include these actions, and they may interfere with a law enforcement investigation. The AAP notes that the dental professional's role in a criminal investigation is to interpret medical information for nonmedical professionals in an understandable manner that accurately reflects the medical evidence [8]. Identify the medical problem, document the suspected abuse (e.g., names, photos, body map, preserve evidence), treat the injuries, and offer honest, factual medical information to parents, families, law enforcement, and justice officials.

Reporting Abuse

As noted in the California Dental Practice Act, dental healthcare professionals have a legal and ethical responsibility to report suspected child abuse to the proper authorities, not to punish perpetrators of abuse but to protect the abuse victims. One author writes, "The dentist must view himself as a child advocate. Simply treating dental and facial injuries of abused children while ignoring the social needs of the child and family is unacceptable" [9].

Nonetheless, the decision of whether or not to report suspected abuse is ethically challenging. Although healthcare professionals are obligated to report suspected abuse, suspicion of abuse is somewhat of a judgment call and certain biases may influence the decision to report. It has been noted that well-intentioned professionals in all fields are swayed by both negative and positive social biases (e.g., sex, race, socioeconomic status, physical appearance, job status), and it is advisable to challenge personal biases and weigh only the facts of the case. A 2008 prospective, observational AAP study found that, "clinicians did not report 27% of injuries considered likely or very likely caused by child abuse and 76% of injuries considered possibly caused by child abuse" because of various biases and experiences [10]. However, patients who had an injury that was not a laceration, who had more than one family risk factor, who had a serious injury, who had a child risk factor other than an inconsistent injury, who had a parental history of substance abuse, or who were unfamiliar to the clinician were more likely to be reported.

Professionally mandated reporters are protected from civil or criminal prosecution in consequence of a good-faith report of abuse, and no clinician in the aforementioned AAP study was sued for malpractice as a result of reporting abuse [7,10]. However, it is possible for dental professionals to be sued, and a state petition for up to $50,000 in recompensatory legal fees is available for dentists having to defend themselves in court [7]. On the other hand, civil or criminal penalties for willfully not reporting abuse or impeding a report when abuse has been found to have occurred include 6 months in jail and/or a fine of $1,000 or, in cases of serious injury/death following a failure to report, 12 months in jail, and/or a fine of $5,000.

ELDER AND DEPENDENT ADULT ABUSE AND NEGLECT

Abusive injuries to the mouth and oral cavity of elder or dependent (e.g., developmentally or physically disabled) adults are similar in type and causation to those sustained by pediatric patients, including trauma from forced feeding, object insertion, mouth gagging, and being slapped, hit, or strangled, but also include damage to and from prostheses. The number of new elder and dependent adult abuse cases is usually about 18,000 per month in California alone, with family members constituting two-thirds of perpetrators [11,26]. However, researchers estimate that for each incident of reported abuse there are at least five (and perhaps up to 14) unreported incidents [11]. Studies have shown that dental professionals are reluctant to report elder or dependent abuse/neglect and that they have a low index of suspicion of this category of abuse [13].

The national frequency of elder abuse is estimated at up to 10%, with some research indicating that the number may be as high as 1 in 6 [14]. The overwhelming majority of abuse and neglect occurs in domestic, rather than institutional (e.g., residential care) settings, largely due to the shift in care in the 20th century from state institutions to the home (particularly for younger disabled individuals) [12,14]. However, with an increasing aging population and longer life expectancies, it is projected that by 2030 there will be a 50% increase in the number of older adults who require nursing home care [14]. Women are the victims of elder abuse two-thirds of the time.

Elder and dependent adults are also at risk for poor oral health due to caretaker neglect. In fact, neglect is one of the most common causes of elder injury reporting [14]. These populations are also at a high risk for self-neglect, accounting for more than 500,000 additional reported cases in the United States per year. A 2010 study revealed that 40% of individuals 65 years of age or older suffer from some form of neglect [15].

Elder and Dependent Adult Abuse Laws

Laws pertaining to mandatory elder and dependent adult abuse reporting are found in the California Welfare and Institutions Code Sections 15600 to 15632 [16].

Section 15600. (a) The Legislature recognizes that elders and dependent adults may be subjected to abuse, neglect, or abandonment and that this state has a responsibility to protect these persons.

(i) Therefore, it is the intent of the Legislature in enacting this chapter to provide that adult protective services agencies, local long-term care ombudsman programs, and local law enforcement agencies shall receive referrals or complaints from public or private agencies, from any mandated reporter submitting reports pursuant to Section 15630, or from any other source having reasonable cause to know that the welfare of an elder or dependent adult is endangered, and shall take any actions considered necessary to protect the elder or dependent adult and correct the situation and ensure the individual's safety.

Section 15630. (a) Any person who has assumed full or intermittent responsibility for the care or custody of an elder or dependent adult, whether or not he or she receives compensation, including administrators, supervisors, and any licensed staff of a public or private facility that provides care or services for elder or dependent adults, or any elder or dependent adult care custodian, health practitioner, clergy member, or employee of a county adult protective services agency or a local law enforcement agency, is a mandated reporter.

(b) (1) Any mandated reporter who, in his or her professional capacity, or within the scope of his or her employment, has observed or has knowledge of an incident that reasonably appears to be physical abuse, abandonment, abduction, isolation, financial abuse, or neglect, or is told by an elder or dependent adult that he or she has experienced behavior, including an act or omission, constituting physical abuse, abandonment, abduction, isolation, financial abuse, or neglect, or reasonably suspects that abuse, shall report the known or suspected instance of abuse by telephone or through a confidential Internet reporting tool, as authorized by Section 15658, immediately or as soon as practicably possible. If reported by telephone, a written report shall be sent, or an Internet report shall be made through the confidential Internet reporting tool established in Section 15658, within two working days.

INTIMATE PARTNER VIOLENCE

Intimate partner violence is defined as violence directed at a "spouse, former spouse, cohabitant, former cohabitant, or person with whom the suspect has had a child or is having or has had a dating or engagement relationship" [7]. According to a 2016 to 2017 survey by the Centers for Disease Control and Prevention, severe physical violence by an intimate partner (including acts such as being hit with something hard, being kicked or beaten, or being burned on purpose) has been experienced by an estimated 32.5% of women and 24.6% of men during their lifetimes [17].

Dental professionals should be vigilant in recognizing signs of abuse among adolescent and adult patients. Up to 50% of abusive injuries occur to the head (particularly areas covered with hair) and neck, and facial injuries occur in 94% of intimate partner violence cases and are similar to those already discussed [7,18]. Again, dental visits may be a patient's only contact with healthcare professionals, making identification of abuse an important part of dental visits [7]. A history of intimidation, fear, isolation, and dependency is often present in victims of abuse, so it is especially important to determine the origin of orofacial or craniofacial injuries through the use of nonjudgmental questions. The Stanford School of Medicine recommends the following lines of indirect questioning for most age groups [31]:

- How are things going at home?

- What about stress levels? How are things going at work? At home?

- How do you feel about the relationships in your life?

- How does your partner treat you?

- Are you having any problems with your partner?

Alternately, lines of direct questioning may be used [31]:

- Did someone kick, hit, hurt, or threaten to hurt you? Was it your parent/caretaker or partner/husband?

- Are you in a relationship with (or do you live with) someone who hits, kicks, or threatens to hurt you?

- Have you ever been slapped, pushed, or shoved by your parent/partner?

- Have there been times when you felt afraid at home being around another person?

- Have you been hit or scared since the last time I saw you?

- Has anyone at home hit you or tried to injure you in any way?

- What kinds of experiences with violence have you had in your life?

- Do you feel controlled or isolated by your partner?

- Does your partner ever try to control you by threatening to hurt you or your family?

- Has anyone close to you ever threatened or hurt you?

- Does your partner ever hit, kick, hurt or threaten you?

- Have you ever been slapped, pushed or shoved by your partner?

- Have you ever been touched in a way that made you feel uncomfortable?

- Has anyone ever made you to do something sexual when you did not want to?

- Has your partner ever refused to practice safe sex?

It is up to the practitioner's judgment which line of questioning to employ. Remember that the objectives are to advocate for and protect the patient. The questions can be framed in a way that does not cause a patient to feel singled out [31]:

- Because unfortunately violence is so common in our society, I have started asking all of my patients about it.

- Because domestic violence has so many effects on health, I now ask all my patients about it.

- From past experience with other patients, I’m concerned that some of your medical problems may be the result of someone hurting you. Is that happening?

- I don’t know if this is a problem for you, but many of my patients are dealing with abusive relationships. Some are too afraid or uncomfortable to bring it up themselves, so I’ve started asking about it routinely.

- Violence affects many families. Violence in the home may result in physical and emotional problems for you and your child. We are offering services to anyone who may be concerned about violence in their home.

When working cross-culturally, it is helpful to learn the colloquialisms used to describe abuse. For example, in some Latino cultures "disrespected me" refers to intimate partner violence or sexual assault [30]. If abuse is suspected and there is a cultural disconnect, consider the assistance of a knowledgeable co-worker, who may be able to act as a cultural broker.

7. CONCLUSION

Although its primary objective is to safeguard the public, the California Dental Practice Act is an excellent resource for dental professionals to ensure compliance with state law. Dental professionals with a good knowledge of the Dental Practice Act and its effects on dental care will practice legally and safely.

8. RESOURCES

California Dental Practice Act

https://www.dbc.ca.gov/about_us/lawsregs/laws.shtml

California Dental Association

https://www.cda.org

Dental Hygiene Board of California

https://dhbc.ca.gov

Works Cited

1. Dental Board of California. Dental Practice Act. Available at https://www.dbc.ca.gov/about_us/lawsregs/laws.shtml. Last accessed January 7, 2025.

2. American Dental Association. High School and College Students. Available at https://www.ada.org/resources/careers/high-school-and-college-students. Last accessed January 7, 2025.

3. California Legislative Information. CA Penal Code Section 11164-11174.3. Available at https://leginfo.legislature.ca.gov/faces/codes_displayText.xhtml?lawCode=PEN&division=&title=1.&part=4.&chapter=2.&article=2.5. Last accessed January 7, 2025.

4. American Academy of Pediatrics. Oral and dental aspects of child abuse and neglect. Pediatrics. 1999;104(2 Pt 1):348-350.

5. Becker DB, Needleman HL, Kotelchuck M. Child abuse and dentistry: orofacial trauma and its recognition by dentists. J Am Dent Assoc. 1978;97(1):24-28.

6. Kellogg N, American Academy of Pediatrics Committee on Child Abuse and Neglect. Oral and dental aspects of child abuse and neglect. Pediatrics. 2005;116(6):1565-1568.

7. Spencer DE. Child abuse: dentists' recognition and involvement. J Calif Dent Assoc. 2004;32(4):299-303.

8. Christian CW, Block R, Committee on Child Abuse and Neglect, American Academy of Pediatrics. Abusive head trauma in infants and children. Pediatrics. 2009;123(5):1409-1411.

9. Bernat JE. Child abuse and neglect: dentistry's role. N Y State Dent J. 1989;55(3):34-37.

10. Flaherty EG, Sege RD, Griffith J, et al. From suspicion of physical child abuse to reporting: primary care clinician decision-making. Pediatrics. 2008;122(3):611-619.

11. California State Legislature. Assembly Bill 2435. Available at http://www.leginfo.ca.gov/pub/09-10/bill/asm/ab_2401-2450/ab_2435_cfa_20100405_092058_asm_comm.html. Last accessed January 7, 2025.

12. Glassman P, Miller C, Ingraham R, Woolford E. The extraordinary vulnerability of people with disabilities: guidelines for oral health professionals. J Calif Dent Assoc. 2004;32(5):379-386.

13. Johnson TE, Boccia AD, Strayer MS. Elder abuse and neglect: detection, reporting, and intervention. Spec Care Dentist. 2001;21(4):141-146.

14. National Center on Elder Abuse. Research: Statistics and Data. Available at https://ncea.acl.gov/researchstatisticsanddata#gsc.tab=0. Last accessed January 7, 2025.

15. Mattoo KA, Shalabh K, Khan A. Geriatric forensics: a dentist's perspective and contribution to identify existence of elder abuse among his patients. J Forensic Dent Sci. 2010;2(2):81-85.

16. California Legislative Information. California Welfare and Institutions Code. Available at https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?sectionNum=15600&lawCode=WIC. Last accessed January 7, 2025.

17. Centers for Disease Control and Prevention. The National Intimate Partner and Sexual Violence Survey: 2016/2017 Report on Intimate Partner Violence. Available at https://www.cdc.gov/nisvs/documentation/NISVSReportonIPV_2022.pdf. Last accessed Janaury 7, 2025.

18. Barkley Burnett L, Adler J. Domestic Violence: Clinical Presentation. Available at http://emedicine.medscape.com/article/805546-clinical#b4. Last accessed January 7, 2025.

19. California Legislative Code. Business and Professions Code Section 1600-1621. Available at https://leginfo.legislature.ca.gov/faces/codes_displayText.xhtml?lawCode=BPC&division=2.&title=&part=&chapter=4.&article=1. Last accessed January 7, 2025.

20. Dental Hygiene Board of California. Laws and Regulations. Available at https://dhbc.ca.gov/lawsregs/index.shtml. Last accessed January 7, 2025.

21. Dental Board of California. Fingerprint Requirement for License Renewal. Available at https://www.dbc.ca.gov/licensees/fingerprint_faq.shtml. Last accessed January 7, 2025.

22. Dental Board of California. Enforcement Program. Available at https://www.dbc.ca.gov/consumers/enforcement.shtml. Last accessed January 7, 2025.

23. Shouse Law Group. How Criminal Convictions Affect California Dental Board Licenses. Available at https://www.shouselaw.com/dentists.html. Last accessed January 7, 2025.

24. California Legislative Code. Business and Professions Code Section 1625–1636.6. http://leginfo.legislature.ca.gov/faces/codes_displayText.xhtml?lawCode=BPC&division=2.&title=&part=&chapter=4.&article=2. Last accessed January 7, 2025.

25. California Legislative Code. Business and Professions Code Section 1648.10–1648.20. Available at http://leginfo.legislature.ca.gov/faces/codes_displayText.xhtml?lawCode=BPC&division=2.&title=&part=&chapter=4.&article=2.9. Last accessed January 7, 2025.

26. California Department of Social Services. Adult Protective Services and County Block Grant Monthly Statistical Report. Available at https://www.cdss.ca.gov/inforesources/Research-and-Data/Disability-Adult-Programs-Data-Tables/SOC-242 . Last accessed January 7, 2025.

27. California Dental Association. Mandatory CURES Consultation in Effect Oct 2. Available at https://www.cda.org/Home/Practice/Practice-Support/Regulatory-Compliance/CURES-and-Opioid-Pain-Management. Last accessed January 7, 2025.

28. Westlaw. California Code of Regulations. Available at https://govt.westlaw.com/calregs/Browse/Home/California/CaliforniaCodeofRegulations?transitionType=Default&contextData=%28sc.Default%29. Last accessed January 7, 2025.

29. County of Orange Social Services Agency. RADAR: A Domestic Violence Intervention. Available at https://www.factoc.org/radar-a-domestic-violence-intervention. Last accessed January 7, 2025.

30. U.S. Department of Justice Office for Victims of Crime. Existe Ayuda (Help Exists) Toolkit. Available at https://ovc.ojp.gov/sites/g/files/xyckuh226/files/pubs/existeayuda/index.html. Last accessed January 7, 2025.

31. Stanford Medicine. Domestic Abuse: How to Ask. Available at https://domesticabuse.stanford.edu/screening/how.html. Last accessed January 7, 2025.

58584 • Infection Control for Dental Professionals: The California Requirement

Mark J. Szarejko, DDS, FAGD

www.netce.com

Copyright © 2025 NetCE, All rights reserved.

Effective infection control techniques are critical to reducing the incidence of infections in dental facilities. Antiseptic techniques and antibiotics will kill micro-organisms, while proper hand hygiene will block their transmission. Gloves, gowns, and masks remove dental professionals from the transmission cycle by protecting them from contact with micro-organisms. Contact Precautions and isolation techniques help patients avoid being vectors of transmission. Lastly, ensuring that dental professionals are immune or vaccinated can help decrease the availability of potential hosts.

Table of Contents

58584 • Infection Control for Dental Professionals: The California Requirement

Course Overview

Audience

Accreditations & Approvals

Designations of Credit

Special Approvals

Course Objective

Learning Objectives

Faculty

Faculty Disclosure

Director of Development and Academic Affairs

Director Disclosure Statement

About the Sponsor

Disclosure Statement

Implicit Bias in Health Care

1. INTRODUCTION

2. INFECTION CONTROL REGULATIONS

BLOODBORNE PATHOGENS STANDARD

CALIFORNIA AEROSOL TRANSMISSIBLE DISEASE STANDARD

3. MODES OF TRANSMISSION

DIRECT AND INDIRECT CONTACT

AEROSOLS, DROPLETS, AND SPLATTER

FOMITE TRANSMISSION

WATER TRANSMISSION

4. STANDARD PRECAUTIONS

HAND HYGIENE

PERSONAL PROTECTIVE EQUIPMENT

RESPIRATORY HYGIENE

ENGINEERING AND WORK PRACTICE CONTROLS (SHARPS SAFETY)

SAFE INJECTION PRACTICES (ASEPTIC TECHNIQUE)

STERILIZATION AND DISINFECTION OF PATIENT-CARE ITEMS AND DEVICES

CLEANING AND DISINFECTION OF ENVIRONMENTAL SURFACES

5. TRANSMISSION-BASED PRECAUTIONS

CONTACT PRECAUTIONS

DROPLET PRECAUTIONS

AIRBORNE PRECAUTIONS

6. PROTECTING DENTAL HEALTHCARE WORKERS

OCCUPATIONAL EXPOSURES

TUBERCULOSIS PREVENTION

VACCINATION

TRAINING AND EDUCATION

7. CONCLUSION

8. DENTAL BOARD OF CALIFORNIA GENERAL PROVISIONS: SECTION 1005. MINIMUM STANDARDS FOR INFECTION CONTROL

Works Cited

58584 • Infection Control for Dental Professionals: The California Requirement

Education Category. Infection Control / Internal Medicine

Release Date. 02/01/2025

Expiration Date. 01/31/2028

Course Overview

Effective infection control techniques are critical to reducing the incidence of infections in dental facilities. Antiseptic techniques and antibiotics will kill micro-organisms, while proper hand hygiene will block their transmission. Gloves, gowns, and masks remove dental professionals from the transmission cycle by protecting them from contact with micro-organisms. Contact Precautions and isolation techniques help patients avoid being vectors of transmission. Lastly, ensuring that dental professionals are immune or vaccinated can help decrease the availability of potential hosts.

Audience

This course is designed for all dentists, dental hygienists, and dental assistants in all practice settings, particularly those practicing in California.

Accreditations & Approvals

NetCE Nationally Approved PACE Program Provider for FAGD/MAGD credit. Approval does not imply acceptance by any regulatory authority or AGD endorsement. 10/1/2021 to 9/30/2027 Provider ID #217994. NetCE is an ADA CERP Recognized Provider. ADA CERP is a service of the American Dental Association to assist dental professionals in identifying quality providers of continuing dental education. ADA CERP does not approve or endorse individual courses or instructors, nor does it imply acceptance of credit hours by boards of dentistry. Concerns or complaints about a CE provider may be directed to the provider or to ADA CERP at www.ada.org/cerp. NetCE is approved as a provider of continuing education by the Florida Board of Dentistry, Provider #50-2405. NetCE is a Registered Provider with the Dental Board of California. Provider Number RP3841. Completion of this course does not constitute authorization for the attendee to perform any services that he or she is not legally authorized to perform based on his or her license or permit type. NetCE is accredited by the International Accreditors for Continuing Education and Training (IACET). NetCE complies with the ANSI/IACET Standard, which is recognized internationally as a standard of excellence in instructional practices. As a result of this accreditation, NetCE is authorized to issue the IACET CEU.

Designations of Credit

NetCE designates this activity for 2 continuing education credits. AGD Subject Code 148. This course meets the Dental Board of California's requirements for 2 unit(s) of continuing education. Dental Board of California course #02-3841-26452. NetCE is authorized by IACET to offer 0.2 CEU(s) for this program.

Special Approvals

This course fulfills the California requirement for 2 hours of infection control education.

Course Objective

The purpose of this course is to familiarize dental professionals with infection control techniques in order to minimize the risks of microbial transmission in the dental healthcare setting.

Learning Objectives

Upon completion of this course, you should be able to:

1. Outline OSHA and Cal/OSHA regulations that impact the provision of dental care.

2. Analyze potential modes of transmission and pathogens that can result in infection in dental facilities.

3. Discuss potential prevention strategies for infection control, including hand hygiene, and personal protective equipment.

4. Describe effective environmental control measures that should be applied in dental care.

5. Identify steps that should be taken to protect dental healthcare personnel, including vaccination, education, and exposure responses.

Faculty

Mark J. Szarejko, DDS, FAGD, received his dental degree from the State University of New York at Buffalo in 1985. He received fellowship from the Academy of General Dentistry in 1994.

Faculty Disclosure

Contributing faculty, Mark J. Szarejko, DDS, FAGD, has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Director of Development and Academic Affairs

Sarah Campbell

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Implicit Bias in Health Care

The role of implicit biases on healthcare outcomes has become a concern, as there is some evidence that implicit biases contribute to health disparities, professionals' attitudes toward and interactions with patients, quality of care, diagnoses, and treatment decisions. This may produce differences in help-seeking, diagnoses, and ultimately treatments and interventions. Implicit biases may also unwittingly produce professional behaviors, attitudes, and interactions that reduce patients' trust and comfort with their provider, leading to earlier termination of visits and/or reduced adherence and follow-up. Disadvantaged groups are marginalized in the healthcare system and vulnerable on multiple levels; health professionals' implicit biases can further exacerbate these existing disadvantages.

Interventions or strategies designed to reduce implicit bias may be categorized as change-based or control-based. Change-based interventions focus on reducing or changing cognitive associations underlying implicit biases. These interventions might include challenging stereotypes. Conversely, control-based interventions involve reducing the effects of the implicit bias on the individual's behaviors. These strategies include increasing awareness of biased thoughts and responses. The two types of interventions are not mutually exclusive and may be used synergistically.

1. INTRODUCTION

In 2023, there were more than 751,000 jobs in dental occupations in the United States[1]. In California alone there are approximately 104,000 dental healthcare professionals, including dentists, dental hygienists, and dental assistants [29]. Most of these dental workers come in daily contact with a variety of infectious diseases in their workplace and are at risk for both transmitting and contracting these diseases.

Universal Precautions were originally developed and recommended by the Centers for Disease Control and Prevention (CDC) in the 1980s as an infection control approach to protect healthcare professionals from bloodborne pathogens. Under Universal Precaution recommendations, all human blood and certain bodily fluids are treated as if they are infectious, regardless of patient or setting. In 1996, the CDC expanded these recommendations and introduced Standard Precautions, not only to protect healthcare workers from pathogens in human blood and body fluids but also from pathogens present in bodily fluids that are not covered under Universal Precautions, including saliva during dental procedures. Standard Precautions are the minimum standard of care applied to all patients, and include hand hygiene, use of specific types of personal protective equipment (PPE) based on anticipated exposure, safe injection practices, and management of contaminated environmental items. In addition to Standard Precautions, Transmission-Based Precautions (i.e., Contact Precautions, Droplet Precautions, and Airborne Precautions) are used to prevent transmission of an infectious agent that is not interrupted by Standard Precautions alone. The type of Transmission-Based Precaution used is based on what is known or suspected about a patient's infection.

In California, to address the issue of infection control and reduce the potential for harm, the Dental Board of California (DBC) established a requirement that licensed dental healthcare professionals in California complete a course on infection control and prevention, further expanding the requirement to all dental health personnel (DHCP), defined as [9]:

...all paid and non-paid personnel in the dental healthcare setting who might be occupationally exposed to infectious materials, including body substances and contaminated supplies, equipment, environmental surfaces, water, or air. DHCP includes dentists, dental hygienists, dental assistants, dental laboratory technicians (in-office and commercial), students and trainees, contractual personnel, and other persons not directly involved in patient care but potentially exposed to infectious agents (e.g., administrative, clerical, housekeeping, maintenance, or volunteer personnel).

The DBC Infection Control standards require that DHCP comply with and enforce the minimum precautions to minimize the transmission of pathogens in healthcare settings, as set forth by Cal/OSHA. These standards are reviewed by the DBC and Dental Hygiene Committee of California to obtain a consensus on infection control standards. A written protocol should be developed for proper instrument processing, operatory cleanliness, and management of injuries, and a copy of infection control regulations should be conspicuously posted in each dental office [9].

2. INFECTION CONTROL REGULATIONS

Legal issues first began to impact infection control practices at the beginning of the acquired immunodeficiency syndrome (AIDS) epidemic in the early 1980s. The need to protect healthcare workers from bloodborne exposures resulted in the publication of the Bloodborne Pathogens Standard by OSHA in 1991 [3].

BLOODBORNE PATHOGENS STANDARD

The OSHA Standard requires employers whose employees have exposure to blood or other potentially infectious material (OPIM) to implement safe work practices, education, and barriers to exposure. OPIM includes saliva in dental procedures and all bodily fluid in situations where it is difficult or impossible to differentiate between bodily fluids; any unfixed tissue or organ (other than intact skin) from a human (living or dead); human immunodeficiency virus (HIV)-containing cell or tissue cultures, organ culture and blood, or other tissues from experimental animals [9]

The OSHA Bloodborne Pathogens Standard requires that all DHCP who may have contact on the job with blood or other bodily fluids must receive specific annual education, which includes instruction in the basics of infection control and prevention. Training must also cover bloodborne pathogens, modes of transmission, the proper use of needles, and Transmission-Based Precautions [2,3].

CALIFORNIA AEROSOL TRANSMISSIBLE DISEASE STANDARD

In 2009, Cal/OSHA adopted the nation's first aerosol transmissible disease (ATD) standard, which remains in effect today. The standard is designed to protect healthcare workers from diseases spread by an airborne or droplet route. The ATD standard requires employers in health care to develop exposure control procedures and train employees to follow those procedures [4]. Basic exposure precautions, such as source screening, infection control, hand hygiene, and cleaning and decontamination procedures, are a fundamental part of the standard. Employees must be included in the periodic review and assessment of these procedures.

According to the California ATD Standard, California dental offices whose patients have suspected or confirmed illnesses that require Airborne or Droplet Precautions, such as tuberculosis (TB) or other respiratory illnesses, must comply with the ATD standards [4]. Key points include:

- Dental employees must be trained to screen patients for ATDs.

- The screening process must be described in a written office procedure.

- Screening must be consistently implemented.

- Elective dental treatment should be deferred until the patient is non- infectious for TB or other diseases requiring Airborne or Droplet Precautions.

A simple screening procedure can be done by the first person who comes in contact with a patient. For example, the patient may be asked "How are you feeling today?" or "Do you have any coughs, fever, or flu-like symptoms?" If the patient is not feeling well or gives a positive answer to any part of the second question, the dental treatment should be rescheduled.

Outpatient dental clinics or offices are not required to comply with this standard if they meet all of the following conditions [4,21]:

- Dental procedures are not performed on patients identified as ATD cases or suspected ATD cases (e.g., persons with TB or other respiratory illnesses).

- The clinic's injury and illness prevention program includes a written procedure for screening patients for ATDs that is consistent with the CDC guidelines for infection control in dental settings. This procedure must be followed before performing any dental work on a patient.

- Employees have been trained in the screening procedure in accordance with state law.

- Aerosol-generating dental procedures are not performed on a patient identified through the screening procedure as presenting a possible ATD exposure risk unless a licensed physician determines that the patient does not currently have an ATD.

As of 2024, California remains the only state with such a permanent standard; however, the coronavirus disease (COVID) pandemic of 2019–2022 highlighted the need for a standard addressing infectious pathogens spread by aerosols or droplets. During the pandemic, OSHA did issue interim guidance for safe workplaces, and some states issued emergency temporary standards. Experts have called for these requirements to be codified in order to ensure the safety of professions and patients, but this has not yet been accomplished [15]. Full guidance on aerosol-transmissible diseases can be found in the 2023 California Workplace Guide to Aerosol Transmissible Diseases at https://www.dir.ca.gov/dosh/dosh_publications/ATD-Guide.pdf [4].

3. MODES OF TRANSMISSION

Almost all pathogens are transmitted by being carried from one place to another. The mode or means of transmission is the weakest link in the chain of infection, and it is the only link that can be eliminated entirely. Most infection control efforts are aimed at preventing transmission of pathogens from a reservoir to a susceptible host. Both Standard and Transmission-Based Precautions are designed to interrupt the mode of transmission. Table 1 details the most common modes of infection transmission in dentistry [5,6,8].

Table 1: COMMON MODES OF INFECTION TRANSMISSION

Category

Definition

Direct contact

Person-to-person transmission of pathogens (e.g., through skin, blood, or body fluid contact)

Indirect contact

An intermediate person or item acts as a transport between the portal of exit in one person and the portal of entry to the next person (e.g., via unwashed hands, shared equipment, needlesticks)

Dropletsa

Large respiratory droplets propelled by an infected person coughing, sneezing, talking, or breathing heavily. Droplets settle rapidly within 6 feet of the individual on surfaces and in the upper airway of individuals exposed via the eyes, nose, or mouth.

Airborne (aerosols)a

Small particles or micro-droplets are released into the air by an infected person coughing, sneezing, talking, or breathing heavily. Airborne pathogens can linger for long periods of time and travel longer distances, landing on surfaces and being breathed in by other individuals into the lower airway.

Fomites

Contact with a contaminated inanimate object (e.g., used gloves, pens, used tissues, soiled laundry, keyboards, furniture).

Water

Water may be contaminated by micro-organisms in dental water unit lines, causing patient contamination as well as dispersing infected airborne particles and droplets.

aIn 2024, a global consensus was reached to replace the terms droplet, airborne, and aerosol with a general umbrella term of "through the air transmission," regardless of infected respiratory particle size and/or distance traveled.

Source: [5,6,8]

DIRECT AND INDIRECT CONTACT

The most common modes of transmission in the healthcare setting are through contact, both direct and indirect. Because it addresses the weakest link in the chain of transmission, hand hygiene is the single most important procedure for preventing the spread of infection. Items moving between patients should be cleaned and sterilized after each use to avoid indirect transmission of pathogens. Standard Precautions in conjunction with identified Contact Precautions are often used in the dental setting.

Bloodborne Pathogens

Healthcare employees can be exposed to blood through needlestick and other sharps injuries, damaged mucous membranes, and broken skin exposures. The pathogens of primary concern to dental professions are HIV, hepatitis B virus, and hepatitis C virus.

Hepatitis B Virus

Healthcare personnel who have received the hepatitis B vaccine and developed immunity to the virus are at virtually no risk for infection. For a susceptible person, the risk from a single needlestick or cut exposure to hepatitis B-infected blood ranges from 6% to 30%, depending on the hepatitis B antigen status of the source individual. While there is a risk for hepatitis B infection from exposures of mucous membranes or nonintact skin, there is no known risk for infection from exposure to intact skin [5,10].

Hepatitis C Virus

Hepatitis C is transmitted primarily through percutaneous exposure to infected blood. The average risk for infection after a needlestick or cut exposure to hepatitis C virus-infected blood is approximately 1.8%. The risk following a blood exposure to the eye, nose, or mouth is unknown but is believed to be very small; however, hepatitis C virus infection from blood splashes to the eye has been reported. There also has been a report of hepatitis C virus transmission that may have resulted from exposure to nonintact skin, but there is no known risk from exposure to intact skin. Documented transmission of hepatitis C or hepatitis B virus has resulted from using the same syringe or vial to administer medication to more than one patient, even if the needle was changed [5,10].

The prevalence of hepatitis C virus infection among dentists and surgeons is similar to that among the general population, approximately 1% to 2% [5]. No studies of transmission from hepatitis C virus-infected DHCP to patients have been reported, and the risk for such transmission appears limited [10].

HIV/AIDS

The average risk of HIV infection after a needlestick or cut exposure to HIV-infected blood is 0.3%; 99.7% of needlestick or cut exposures do not lead to infection. The risk after exposure of the eye, nose, or mouth to HIV-infected blood is estimated to be 0.1%. There have been no documented cases of HIV transmission due to an exposure involving a small amount of blood on intact skin (i.e., a few drops of blood on skin for a short period of time) [5,10].

In the United States, the risk of HIV transmission in dental settings is extremely low. According to surveillance data from 1981 to 2013, a total of 58 cases of HIV seroconversion had been documented among healthcare personnel after occupational exposure to a known HIV-infected source, but none were among dental care personnel [12].

Certain factors affect the risk of HIV transmission after an occupational exposure. Laboratory studies have determined if needles that pass through latex gloves are solid rather than hollow-bore or are of small gauge (e.g., anesthetic needles), less blood is transferred. In a retrospective, case-control study of healthcare personnel, an increased risk for HIV infection was associated with exposure to a relatively large volume of blood, as with a deep injury with a device that was visibly contaminated with the patient's blood or a procedure that involved a needle placed in a vein or artery [12]. The risk was also increased if the exposure was to blood from patients with terminal illnesses, possibly reflecting the higher titer of HIV in patients with late-stage AIDS.

AEROSOLS, DROPLETS, AND SPLATTER

Aerosols, droplets (produced by the respiratory tract), and splatter contaminated with blood and bacteria are produced during many dental procedures. Devices such as dental handpieces, ultrasonic and sonic scalers, air polishers, air-water syringes, and air abrasion units produce visible aerosol clouds and possible airborne contamination. Splatter generated by dental procedures such as drilling is a primary risk for transmission of bloodborne pathogens. In general, because of their smaller size, aerosols pose the greatest risk for airborne infection [9].

Several studies have shown that airborne or droplet nuclei may extend up to 6 feet away from the source and can remain airborne for up to 30 minutes after a procedure. Tuberculosis (TB) is of special concern because it is a large particle that can remain airborne or can dry on a surface and become airborne again as part of a dust particle.

In 2024, the World Health Organization (WHO) and the Centers for Disease Control and Prevention from the United States, China, Europe, and Africa, published a global consensus of the terminology for pathogens that transmit through the air. Key changes include [8]:

- Any infected particles that are expelled from an individual through nose or mouth are referred to as "infectious respiratory particles" (IRPs).

- IRPs exist on a spectrum of sizes and should no longer be distinguished as "small" (aerosol) or "large" (droplet).

- The descriptor "through the air transmission" should be used to characterize any transmission that involves a pathogen moving through the air or being suspended in the air. Two further descriptors can be used:

- Airborne transmission or inhalation: IRPs are expelled into the air and inhaled by another person. This can occur at short or long distances, dependent on various factors (e.g., airflow, humidity, temperature, ventilation).

- Direct deposition: IRPs are expelled into the air and directly deposited on the exposed mouth, nose, or eyes of another person.

Due to the existing research and recommendations primarily using the terms and definitions of "aerosol" and "droplet," these terms will continue to be used throughout this course, unless otherwise noted.

The American Dental Association recommends that in addition to using Universal and Standard Precautions, such as masks, gloves, and eye protection, Transmission-Based Precautions, including the proper sterilization of instruments and treatment of dental unit waterlines is necessary to reduce or eliminate this source of potentially contaminated dental aerosols. Preprocedural rinsing with an antimicrobial mouthwash such as chlorhexidine is also recommended, although it is only effective for oral bacteria found in saliva and those adhering to mucous membranes. It does not penetrate subgingivally and likely has no effect on bacteria in the nasopharynx [5,6].

Diseases known to spread by aerosols or droplet include:

- TB

- Pneumonic Yersinia pestis infection (plague)

- Influenza

- Legionellosis (Legionnaires disease)

- Measles

- Chickenpox

- Disseminated shingles

- Severe acute respiratory syndrome and coronavirus (SARS and COVID)

Procedures or equipment aimed at eliminating the means of transmission include [5,6]:

- Universal preprocedural rinses

- Dental dams for certain procedures

- High-volume evacuator (HVE) at the treatment site (An HVE can only remove airborne contamination if it removes a large volume of air. A saliva ejector does not remove enough air to be classified as an HVE.)

- High-efficiency particulate arresting and ultraviolet filters in the ventilation system

- Disposable PPE discarded after each patient (e.g., gloves, masks, gowns)

- Cleaning, disinfection, and sterilization of equipment used by more than one patient

- Environmental cleaning and disinfection, especially of high-touch surfaces

FOMITE TRANSMISSION

Devices can transmit pathogens if they are contaminated with blood or bodily fluids or are shared without cleaning, disinfecting, and sterilizing between patients; these are classified as fomites. Surgical instruments that are inadequately cleaned between patients or that have manufacturing defects that interfere with the effectiveness of reprocessing may transmit bacterial, fungal, and viral pathogens. Clothing, uniforms, laboratory coats, or gowns used as PPE may become contaminated with potential pathogens after care of a patient colonized or infected with an infectious agent [5,6,10].

WATER TRANSMISSION

Dental water units and dental unit waterlines are both potential sources of transmission and potential reservoirs. Routine cleaning and sterilization and adherence to the CDC's recommended procedures for treating dental unit waterlines have been shown to be effective in eliminating transmission of infectious organisms via these devices. Infections known to be caused by dental-related water transmission include Pseudomonas aeruginosa, Mycobacterium avium, and Legionella pneumophila [5,7].

4. STANDARD PRECAUTIONS

In 1986, California became the first state to pass a comprehensive bloodborne pathogen standard. The California standard provided a model for federal legislation, and in 1991, OSHA published its Bloodborne Pathogens Standard [3,30]. Since then, regulatory and legislative activity has focused on implementing a hierarchy of prevention and control measures to improve infection control in healthcare settings.

The gradual acceptance of various infection prevention standards has changed the way we work in the provision of dental care. The DBC defines Standard Precautions as "a group of infection prevention practices that apply to all patients, regardless of suspected or confirmed infection status, in any setting in which healthcare is delivered" [9]. The DBC mandates that Standard Precautions must be practiced in the care of all patients, and all body fluids, except sweat, are considered potentially infectious [9]. The use of Standard Precautions reduces the risk of infection to staff and patients and ensures that the right precautions are used with both known and unknown carriers of diseases due to bloodborne pathogens. Standard Precautions apply to contact with blood, intact or nonintact skin, mucous membranes, and all bodily fluids, secretions, and excretions (except sweat), regardless of whether they contain blood. A central tenet of Standard Precautions is to consider all patients to be potentially infected with a bloodborne pathogen. Saliva has always been considered a potentially infectious material in dental infection control; thus, no operational difference exists in clinical dental practice between Universal Precautions and Standard Precautions. For organisms other than bloodborne pathogens, early identification and prompt isolation are critical.

As noted, Standard Precautions are the minimum infection prevention practices that apply to all patient care, regardless of health or dental care setting, and include [5]:

- Utilization of effective hand hygiene

- Use of PPE (e.g., gloves, masks, eyewear)

- Respiratory hygiene, including cough/ sneeze etiquette

- Sharps safety (engineering and work practice controls)

- Safe injection practices (aseptic technique)

- Cleaning, sterilization, and disinfection of instruments and devices

- Cleaning and disinfection of environmental surfaces

HAND HYGIENE

Despite the simplicity and effectiveness of hand hygiene in preventing the spread of infectious disease, adherence to hand hygiene practice remains low. Adherence varies among professional categories of healthcare workers but is usually estimated at less than 50%. Healthcare providers may be required to clean their hands as many as 100 times in a 12-hour shift, depending on the number of patients and intensity of care [14,17]. For dental healthcare workers, strict adherence to proper hand hygiene is the most important prevention strategy to protect both the patient and the worker. In one study, adherence rates to hand hygiene among postgraduate-year dentists found that overall handwashing compliance rate was 34.7%, with higher rates of compliance noted in oral surgery services (92.8%) than during work in general clinical practice (34.2%) [13]. The World Health Organization has designed the guidelines 5 Moments for Hand Hygiene as a reminder of when proper hand hygiene should be completed [11]:

1. Before touching a patient

2. Before a procedure

3. After a procedure or exposure to body fluids

4. After touching a patient

5. After touching a patient's surroundings

In general, perform hand hygiene [14]:

- After contact with any bodily fluids, including your own

- Before any non-invasive or invasive procedure

- Each time you remove your gloves

- When your hands feel or look dirty

- After contact with contaminated things or environments, such as charts

- After handling used equipment or linen

- After using the bathroom

- Before contact with any portal of entry, your patient's or your own

- Before and after eating

A number of conditions restrict DHCP from participating in direct patient care. These include weeping dermatitis, exudative lesions, or any hand condition that increases the risk of disease transmission [9].

Good handwashing is difficult to practice, is rarely known or taught, and is one of the single most effective ways to prevent transmission of many diseases, including influenza. Everyone knows to wash their hands before eating and after using the restroom. However, few do little more than remove obvious dirt. Good handwashing involves removing the skin oils where organisms can remain even when the hands look clean. A quick pass under the water faucet and fast dry with a towel may remove visible dirt, but the oils and organisms remain.

To effectively remove the oils and organisms, the process should take at least 20 seconds, or the amount of time it takes to sing "Twinkle, Twinkle Little Star." The hands should be soaped and rubbed vigorously for 15 seconds to create a good lather and to assure that all parts of each hand are soaped and rubbed well. Then, the hands should be rinsed thoroughly and dried, preferably with a paper towel. The towel should be used to turn off the water faucet and then properly thrown away. However, 20 seconds is a long time in the busy life of a healthcare provider, and this 20 seconds has been identified as a major barrier to handwashing, particularly among those who consider themselves "too busy" to wash their hands. If there is no visible dirt or contamination, a waterless hand sanitizer with at least 60% alcohol can be used between patients. However, nothing is as good as washing well with soap and water. Further, some organisms are not eliminated through the use of hand sanitizers alone (e.g., Clostridioides difficile spores). Hands should be thoroughly dried before donning gloves and washed again immediately after glove removal [9].

Some mistakenly think that hot water must be used to kill the organisms. Water hot enough to kill organisms would be too hot to touch. Warm water softens oils but mainly adds to comfort and encourages better washing technique (i.e., longer duration). Careful attention to handwashing and cleansing may result in chapped skin, so the dental professional must find effective lotions to care for his/her hands [14,17].

Certain soaps contain stronger antiseptic compounds, such as chlorhexidine, and these soaps may be considered in cases in which exposure to potentially infectious material is likely. Antiseptic soaps or surgical preparation liquids have been found more effective than plain soap in removing bacteria from healthcare workers hands both pre- and postprocedure. In addition, antiseptics may be added to alcohol-based handrubs in order to achieve persistent germicidal activity. Possible side effects associated with frequent use of antiseptic hand scrubs include skin irritation, dermatitis, allergic reactions, and potential development of microbial resistances. Chlorhexidine products are considered safe for regular use in dental practice; however, if associated side effects are bothersome, they may result in decreased hand hygiene compliance [10,14].

In summary, start and end each work day using an antibacterial soap. Gloves provide a breeding ground for microbial growth, and washing before and after use is encouraged. If hands are not visibly soiled, a waterless hand sanitizer (at least 60% alcohol) may be used. For surgical procedures, wash hands with antimicrobial soap prior to gowning and gloving [5].

PERSONAL PROTECTIVE EQUIPMENT

PPE is defined as special coverings designed to protect healthcare personnel from exposure to or contact with infectious agents [18]. Cal/OSHA regulations require use of PPE in dental care settings to protect personnel from exposure to bloodborne pathogens and other OPIM [9]. Under OSHA's General Duty Clause, PPE is also required for any potential infectious disease exposure. Employers must provide their employees with appropriate PPE and ensure its proper disposal. If reusable, it must be properly cleaned or laundered, repaired, and stored after use [19]. PPE must fit the individual user, and it is up to the employer to ensure that PPE is available in sizes appropriate for all their workers. Employees are prohibited from taking PPE home to launder.

In addition to the familiar gloves, masks, and gowns, PPE includes a variety of barriers and respirators used alone or in combination to protect skin, mucous membranes, and airways from contact with infectious agents. The selection of PPE is based on the nature of the patient/provider interaction and the likely mode of transmission. Primary PPE used in oral healthcare settings includes gloves, surgical masks, respiratory devices, protective eyewear, face shields, and protective shoes and clothing.

Procedures that can generate splashes or sprays of blood, bodily fluids, secretions, excretions, or chemical agents require either a face shield (disposable or reusable) or mask and goggles. The wearing of masks, eye protection, and face shields in specified circumstances (when blood or OPIM exposures are likely to occur) is mandated by the OSHA Bloodborne Pathogens Standard. Sterile barriers for invasive procedures and masks or respirators for the prevention of droplet contamination are also required [2].

The use of PPE is not a substitute for safe work practices. Avoid contaminating yourself by keeping your hands away from your face and not touching or adjusting equipment. PPE is a potential means of transmission if not changed between patients. All PPE should be removed when leaving patient care areas.

Gloves

DHCP should wear medical exam gloves to prevent contamination of their hands when touching mucous membranes, blood, saliva, or OPIM [9]. Gloves reduce the likelihood that micro-organisms present on the hands will be transmitted to patients during surgical or other patient-care procedures. Gloves used in the healthcare setting are subject to U.S. Food and Drug Administration (FDA) evaluation and clearance. Nonsterile, disposable medical gloves made of latex or nitrile should be available for routine patient care. Dental personnel should always use gloves when [18]:

- Anticipating direct contact with blood or bodily fluids, mucous membranes, nonintact skin, and OPIM

- Engaging in direct contact with patients who are colonized or infected with pathogens transmitted by the contact route, such as vancomycin-resistant enterococci or methicillin-resistant Staphylococcus aureus (MRSA)

- Handling or touching visibly or potentially contaminated patient care equipment and environmental surfaces

Studies have repeatedly shown that vinyl gloves have higher failure rates than latex or nitrile gloves. For this reason, either latex or nitrile gloves are preferable for clinical procedures that require manual dexterity or those involving more than brief patient contact. Heavier, reusable utility gloves should be used for non-patient-care activities, such as handling or cleaning contaminated equipment or surfaces, handling chemicals, or disinfecting contaminated tools [9,18].

During dental procedures, patient examination gloves commonly contact multiple types of chemicals and materials, such as disinfectants and antiseptics, composite resins, and bonding agents, and these materials can compromise the integrity of latex, nitrile, and other synthetic glove materials. In addition, latex gloves can interfere with the setting of vinyl polysiloxane impression materials. Given the diverse selection of dental materials on the market, dental practitioners should consult glove manufacturers regarding the chemical compatibility of glove materials [5,18].

Wearing sterile surgeon's gloves during surgical procedures has a strong theoretical rationale. Sterile gloves minimize transmission of micro-organisms from the hands of surgical personnel to patients and prevent contamination of the hands of surgical personnel with the patient's blood and bodily fluids. In addition, sterile surgeon's gloves are more rigorously regulated by the FDA and may provide an increased level of protection for the provider if exposure to blood is likely [10,18].

Gloves should be removed and replaced if torn or punctured and discarded between patients to prevent transmission of infectious material. They should never be washed and reused, as micro-organisms cannot be removed reliably from glove surfaces. Glove reuse has been associated with transmission of MRSA and gram-negative bacilli [9,10].

When gloves are worn in combination with other PPE, they should be put on last. Gloves that fit snugly around the wrist are preferred for use with a gown because they will cover the gown cuff and provide a more reliable continuous barrier for the arms, wrists, and hands. Removing gloves properly also prevents hand contamination. Hand hygiene following glove removal ensures that the hands will not carry potentially infectious material that might have penetrated through unrecognized tears or contaminated the hands during glove removal. When processing contaminated sharp instruments, needles, and devices, heavy utility gloves should be used to prevent puncture injuries [10,18].

When adhering to Standard Precautions, always [5]:

- Use good hand hygiene.

- Use gloves for contact with blood, bodily fluids, nonintact skin (including rashes), mucous membranes, used equipment, linens, and trash.

- Change gloves if they become heavily soiled when working on a patient or if you must go from a potentially more infective area to a lesser one.

In addition, never:

- Wear artificial fingernails.

- Touch a second patient with the same pair of gloves used on the first patient.

- Contaminate the environment with dirty gloves.

- Wear gloves outside the treatment area unless you can say why you are wearing them.

Protective Clothing

Gowns are intended to protect the arms and exposed body areas and prevent contamination of clothing with blood, bodily fluids, and OPIM. The type of gown selected is based on the nature of the patient/provider interaction, including the anticipated degree of contact with infectious material and potential for blood and bodily fluid penetration of the barrier. General work clothes (e.g., uniforms, scrubs, laboratory coats, jackets) are not considered PPE. Dental personnel should change protective clothing when it becomes visibly soiled or as soon as possible if penetrated by blood or other possibly infectious fluid [18].

California regulations require that all DHCP wear reusable or disposable protective attire when their clothing or skin is likely to be exposed to aerosol spray or splashing or spattering of blood, OPIM, or chemicals and germicidal agents. Gowns must be changed daily or between patients if they become moist or visibly soiled. All PPE used during patient care shall be removed when leaving laboratories or areas of patient care activities. Reusable gowns should be laundered in accordance with Cal/OSHA Bloodborne Pathogens Standards. In addition, gowns should be worn for disinfection, sterilization, and housekeeping procedures involving the use of germicides or handling contaminated items [9].

Masks, Protective Eyewear, and Face Shields

In California, DHCP are required to wear surgical masks that cover both the nose and mouth, in combination with either chin-length plastic face shields or protective eyewear when there is potential for splashing or spattering of blood, droplets, chemical, or germicidal agents, or OPIM. After each patient, masks should be changed and disposed of properly. After each patient treatment, face shields and protective eyewear shall be disposed or cleaned and disinfected [9,18].

Masks should fit snugly and fully cover the nose and mouth to prevent fluid penetration. For this reason, masks that have a flexible nose piece and can be secured to the head with string ties or elastic are preferable. Surgical masks protect against micro-organisms generated by the wearer and also protect dental personnel from large-particle droplet spatter that might contain bloodborne pathogens or OPIM. If the mask becomes wet or contaminated, it should be changed between patients or even during patient treatment. For employees at increased risk of exposure to ATDs, such as those working in endemic areas (e.g., Southeast Asia) or in areas designated for isolation or quarantine, the employer must provide a respirator at least as effective as an N95 respirator.

Most surgical masks are not National Institute for Occupational Safety and Health (NIOSH)-certified as respirators, do not protect the user adequately from exposure to TB, and do not satisfy OSHA requirements for respiratory protection. However, certain surgical masks (i.e., N95 respirators) do meet the requirements and are certified by NIOSH. The level of protection a respirator provides is determined by the efficiency of the filter material for incoming air (e.g., 95% for N95) and how well the face piece fits or seals to the face. N95 respirators are required to be labeled as such on the device.

Respirators are used when treating patients with diseases requiring Airborne Precautions and should be used in the context of a complete respiratory protection program. This program should include training and fit testing to ensure an adequate seal between the edges of the respirator and the wearer's face.

Goggles with side shields provide barrier protection for the eyes and should fit snugly over and around the eyes or personal prescription lenses. Personal prescription lenses do not provide optimal eye protection and should not be used as a substitute for goggles. If goggles or face shields are reusable, they must be placed in a designated receptacle for subsequent reprocessing. If they are not reusable, they may be discarded in a designated waste receptacle.

Face shields extending from chin to crown provide better face and eye protection from splashes and sprays than goggles. Shields that wrap around the sides may reduce splashes around the edge. Removal of a face shield, goggles, and mask can be performed safely after gloves have been removed and hand hygiene performed. The ties, earpieces, or headband used to secure the equipment to the head are considered clean and therefore safe to touch with bare hands. The front of the face shield is considered contaminated [10,18].

RESPIRATORY HYGIENE

If dental clinics and offices comply with state regulations for screening of patients with ATDs, they are not required to comply with the new standards for prevention of transmission of ATDs [4]. However, because no screening process is universally effective, dental personnel should be aware of the potential dangers associated with transmission of pathogens via the airborne and droplet routes.

Respiratory droplets can transmit infection when they travel directly from the respiratory tract of the infected individual to the mucosal surfaces of the recipient, generally over short distances (i.e., 6 feet or less). Airborne transmission occurs with only a few organisms that can survive the drying of respiratory droplets. When the droplets evaporate, they leave behind droplet nuclei, which are so small they remain suspended in the air and can travel over longer distances. Respiratory droplets and droplet nuclei are generated when an infected person coughs, sneezes, or talks during procedures. Facial masks or shields generally provide direct protection from droplet transmission. Some pathogens transmitted via the airborne route (e.g., TB) require the use of an N95 respirator or better (e.g., N99, N100) due to the small particle size [5].

Measures to contain respiratory secretions in symptomatic patients and accompanying adults may include [5,18]:

- Post signs to instruct patients with known or suspected respiratory infection to cover mouth and nose when sneezing or coughing, use and properly dispose of tissues, and wash hands after sneezing or coughing.

- Provide tissues and no-touch receptacles.

- Have handwashing stations or hand sanitizer available in waiting areas.

- Offer masks to patients and accompanying adults.

- Provide ample space in waiting areas, or consider placing symptomatic patients in a separate waiting area.

ENGINEERING AND WORK PRACTICE CONTROLS (SHARPS SAFETY)

Most percutaneous injuries among DHCP involve scalers, burs, needles, wires, and sharp instruments. In 2000, the Federal Needlestick Safety and Prevention Act authorized OSHA to revise its Bloodborne Pathogens Standard to require the use of safety-engineered sharp devices in healthcare settings [2,3,16]. Guidelines on the design, implementation, and evaluation of a sharps injury prevention program have been developed by the CDC, and outline engineering controls and work practice controls as primary methods to prevent such occurrences. Engineering controls, such as sharps disposal containers, self-sheathing needles, and safer medical devices (e.g., sharps with engineered sharps injury protections and needleless systems) isolate or remove the bloodborne pathogens hazard from the workplace. On the other hand, work practice controls reduce the likelihood of exposure by specifying the manner in which a task is performed (e.g., prohibiting recapping of needles by a two-handed technique).

Engineering and work practice controls are intended to work synergistically to eliminate or minimize employee exposure. These controls must be examined and maintained or replaced on a regular basis to ensure their effectiveness. To maintain a safe workplace, employers must provide handwashing facilities that are readily accessible to employees.

Contaminated needles and other contaminated sharps should not be bent, recapped, or removed unless the employer can demonstrate that there is no alternative or that such action is required by a specific procedure. Necessary bending, recapping, or needle removal must be accomplished through the use of a mechanical device or a one-handed scoop technique. Shearing or breaking of contaminated needles is prohibited. Immediately, or as soon as possible after use, contaminated reusable sharps (e.g., scalpels, dental knives) must be placed in appropriate containers until properly reprocessed. These containers must be [9,10]:

- Puncture resistant

- Labeled or color-coded

- Leak-proof on the sides and bottom

- Maintained in accordance with OSHA requirements for reusable sharps

- Designed so personnel are not required to reach by hand into the container

- Located as close as possible to the point of use

SAFE INJECTION PRACTICES (ASEPTIC TECHNIQUE)

Safe injection practices are designed to prevent disease transmission within the healthcare setting. The absence of visible blood or other signs of contamination in a used syringe does not mean the item is free from potentially infectious agents. Bacteria and other microbes can be present without any visible evidence of contamination. All used injection supplies and materials should be considered potentially contaminated and should be discarded.

To ensure safe injection practices, use aseptic technique throughout all aspects of injection preparation and administration. Aseptic technique involves the handling, preparation, and storage of medications in a manner that prevents microbial contamination. It also applies to the handling of all supplies used for injections and infusions. To avoid contamination, medications should be drawn in a clean medication preparation area. Any item that may have come in contact with blood or OPIM should be kept separate from medications. In addition, eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses are prohibited in work areas where there is a reasonable likelihood of occupational exposure. Food and drink should not be kept in refrigerators, freezers, shelves, or cabinets or on countertops where blood or OPIM is present.

A new, sterile syringe and needle should be used to draw up medications while preventing contact between the injection materials and the nonsterile environment. Practice proper hand hygiene before handling medications, and discard medication vials upon expiration or any time there are concerns regarding the sterility of the medication [5].

Never leave a needle or other device inserted into a vial or bottle for multiple uses. This provides a direct route for micro-organisms to enter the vial and contaminate the fluid. Medications should never be combined between vials or administered from the same syringe to more than one patient, even if the needle is changed. Multidose vials should be used on a single patient whenever possible and should never enter the immediate patient treatment area [5].

Dental personnel should follow proper technique when using and handling needles, cannulae, and syringes. Whenever possible, use sharps with engineered sharps injury protections (e.g., non-needle or needle devices with built-in safety features or mechanisms that effectively reduce the risk of an exposure incident). Do not disable or circumvent the safety feature on devices [5].

Cases of bloodborne pathogen transmission as a result of improper injection practices have common themes. Often, aseptic technique and Standard Precautions were not carefully followed. Infection control programs may be lacking or responsibilities unclear. In several instances, failure to recognize an infection control breach has led to prolonged transmission and a growing number of infected patients. In all cases, investigations were time-consuming and costly and required the notification, testing, and counseling of hundreds and sometimes thousands of patients [5,16].

STERILIZATION AND DISINFECTION OF PATIENT-CARE ITEMS AND DEVICES

Application of accepted infection control principles helps maintain a safe environment for both patients and dental care workers. This includes proper use of Standard Precautions and application of approved techniques for cleaning, disinfection, sterilization, and reprocessing of dental equipment. Healthcare policies must identify—primarily on the basis of an item's intended use—whether cleaning and disinfection or sterilization is indicated (Table 2) [9,10,21].

Table 2: METHODS FOR STERILIZING AND DISINFECTING PATIENT-CARE ITEMS AND ENVIRONMENTAL SURFACES

Process

Result

Method

Examples

Patient Care Items

Environmental Surfaces

Sterilization

Destroys all forms of viable micro-organisms, including bacterial spores.

Heat-automated, high temperature

Steam, dry heat, unsaturated chemical vapor

Heat-tolerant critical and semicritical

NA

Heat-automated, low temperature

Ethylene oxide gas, plasma sterilization

Heat-sensitive critical and semicritical

Liquid immersiona

Glutaraldehyde, glutaraldehydes with phenols, hydrogen peroxide, hydrogen peroxide with peracetic acid, peracetic acid

High-level disinfection

Destroys all micro-organisms, but not necessarily high numbers of bacterial spores.

Heat-automated

Washer disinfector

Heat-sensitive semicritical

NA

Liquid immersiona

Glutaraldehyde, glutaraldehydes with phenols, hydrogen peroxide, hydrogen peroxide with peracetic acid, ortho-phthalaldehyde

Intermediate-level disinfection

Destroys vegetative bacteria and most fungi and viruses. Inactivates Mycobacterium bovisb. Not necessarily capable of killing bacterial spores.

Liquid contact

EPA-registered hospital disinfectant with label claim of tuberculocidal activity (e.g., chlorine-containing products, quaternary ammonium compounds with alcohol, phenolics, bromides, iodophors, EPA-registered chlorine-based product)

Noncritical with visible blood

Clinical contact surfaces, blood spills on housekeeping surfaces

Low-level disinfection

Destroys most vegetative bacteria and certain fungi and viruses. Does not inactivate Mycobacterium bovis.

Liquid contact

EPA-registered hospital disinfectant with no label claim regarding tuberculocidal activity. OSHA also requires label claim of HIV and HBV potency for use of low-level disinfectant for use on clinical contact surfaces (e.g., quaternary ammonium compounds, some phenolics, some iodophors)

Noncritical without visible blood

Clinical contact surfaces, housekeeping surfaces

aContact time is the single critical variable distinguishing the sterilization process from high-level disinfection with FDA-cleared liquid chemical sterilants. High-level disinfection uses shorter submersion times.

bInactivation of the more resistant Mycobacterium bovis is used as a benchmark to measure germicidal potency.

Source: [9,10,21]

Cleaning is defined as the removal of visible soil (organic and inorganic material) debris and OPIM from objects and surfaces; normally, it is accomplished manually or mechanically using water with detergents or enzymatic products [9]. Cleaning must precede any disinfection or sterilization process.

Decontamination reduces the number of pathogenic micro-organisms on objects, usually with a 0.5% chlorine solution [21]. Thorough cleaning and decontamination are essential before high-level disinfection and sterilization because inorganic and organic materials that remain on the surfaces of instruments interfere with the effectiveness of these processes.

Disinfection is a process that eliminates many or all pathogenic micro-organisms, except bacterial spores, on inanimate objects. In healthcare settings, objects are usually disinfected using liquid chemicals or wet pasteurization (i.e., the use of hot water to destroy micro-organisms). There are three levels of disinfection [9,10]:

- High-level disinfection: Used to disinfect patient-care equipment that touches mucous membranes or blood.

- Intermediate-level disinfection: Used mainly to disinfect items that have contact with intact skin, but is appropriate for certain semicritical items (e.g., chair arms).

- Low-level disinfection: Used to disinfect the healthcare environment or items that touch intact skin.

Surface disinfection is an important part of environmental cleaning. Most bacteria and mycobacteria (e.g., TB) survive for several months on dry surfaces [20]. Respiratory viruses, such as coxsackie or influenza, can persist on surfaces for a few days. Hepatitis viruses and HIV can persist for more than one week, and herpes viruses have been shown to persist from only a few hours up to seven days [20]. All surfaces in patient care areas should be cleaned then disinfected according to the manufacturer's instructions and allowed to dry completely.

Sterilization is a process that destroys or eliminates all forms of microbial life and is carried out in healthcare facilities by physical or chemical methods. Sterile and nonsterile are absolute concepts. If a sterile item is touched by anything nonsterile, the formerly sterile item is contaminated.

The sterilization area should be separate from any patient care or staff break areas. The sterilization section of the processing area should include the sterilizers and related supplies, with adequate space for loading, unloading, and cool down [10]. The area can also include incubators for analyzing spore tests and enclosed storage for sterile items and single-use items. Manufacturer and local building code specifications will determine placement and room ventilation requirements.

According to the CDC guideline, heat-tolerant dental instruments usually are sterilized by steam under pressure (autoclaving), dry heat, or unsaturated chemical vapor [10]. All sterilization should be performed by using medical sterilization equipment cleared by the FDA. The sterilization times, temperatures, and other operating parameters recommended by the manufacturer of the equipment used, as well as instructions for correct use of containers, wraps, and chemical or biological indicators, should always be followed [10]. Sterilization most often fails due to overloading.

Devices being sterilized should first be cleaned, as debris interferes with the sterilization process. If an ultrasonic unit is utilized, it should be covered while actively in use. Instruments should be fully dry prior to packaging and storage.

Storage practices for wrapped sterilized instruments can be either date- or event-related. Packages containing sterile supplies should be inspected before use to verify barrier integrity and dryness. Although some facilities continue to date every sterilized package and use shelf-life practices, other facilities have switched to event-related practices [10]. This approach recognizes that the product should remain sterile indefinitely, unless an event causes it to become contaminated (e.g., torn or wet packaging). Even for event-related packaging, the date of sterilization should be placed on the package, and if multiple sterilizers are used in the facility, the sterilizer used should be indicated on the outside of the packaging material to facilitate the retrieval of processed items in the event of a sterilization failure [10]. If packaging is compromised, the instruments should be re-cleaned, sterilized again, and packaged in new wrap.

Categorizing Patient-Care Items

Patient-care items (e.g., dental instruments, devices, and equipment) are categorized using the Spaulding classification system as critical, semicritical, or noncritical, depending on the potential risk for infection associated with their intended use.

Critical items are those items that enter sterile spaces, such as soft tissue or bone, or items that come into contact with the bloodstream. These items pose the greatest risk of transmitting infection and require sterilization. Examples of critical dental instruments include surgical instruments, periodontal scalers, scalpel blades, and surgical dental burs [9,10]. Critical instruments, items, and devices should be discarded or pre-cleaned, packaged or wrapped, and sterilized after each use. Methods of sterilization include steam under pressure (autoclaving), chemical vapor, and dry heat. If a critical item is heat-sensitive, it should, at minimum, be processed with high-level disinfection and packaged or wrapped after disinfection. These instruments, items, and devices shall remain sealed and stored in a manner so as to prevent contamination and shall be labeled with the date of sterilization and the specific sterilizer used if more than one sterilizer is utilized in the facility [9].

Semicritical items touch intact mucous membranes or nonintact skin and have a lower risk of transmission. Examples of semicritical dental instruments include mouth mirrors, amalgam condensers, reusable dental impression trays, and dental handpieces. Because the majority of semicritical items in dentistry are heat-tolerant, they should be sterilized using heat. If a semicritical item is heat-sensitive, it should, at a minimum, be processed with high-level disinfection, which kills all microbial life except spores [9,10,21]. Semi-critical instruments, items, and devices should be pre-cleaned, packaged or wrapped, and sterilized after each use. Methods of sterilization include autoclaving, chemical vapor, and dry heat. If a semi-critical item is heat sensitive, it should, at minimum, be processed with high-level disinfection and packaged or wrapped upon completion of the disinfection process. These packages or containers shall remain sealed, shall be stored in a manner so as to prevent contamination, and shall be labeled with the date of sterilization and the specific sterilizer used if more than one sterilizer is utilized in the facility [9].

Noncritical items pose the least risk of transmission of infection and include devices, equipment, and surfaces that come in contact with soil, debris, saliva, blood, OPIM, and intact skin, but not mucous membranes [9]. Noncritical items include radiograph heads/cones, blood pressure cuffs, facebows, and pulse oximeters. In the majority of cases, cleaning and disinfection with a California Environmental Protection Agency (CalEPA)-registered hospital low-level disinfectant labeled effective against HBV and HIV is adequate. When the item is visibly contaminated with blood or OPIM, a CalEPA-registered hospital intermediate-level disinfectant with a tuberculocidal claim (i.e., intermediate-level disinfectant) should be used [9,10].

High-speed dental hand pieces, low-speed hand pieces, rotary components and dental unit attachments (e.g., reusable air or water syringe tips and ultrasonic scaler tips) shall be packaged and heat-sterilized in a manner consistent with the same sterilization practices as a semi-critical instrument or item [9]. Single-use disposable items such as prophylaxis angles, cups, brushes, tips for high-speed evacuators, saliva ejectors, air and water syringe tips, and gloves must be used for one patient only and discarded. California requires proper functioning of the sterilization cycle of all sterilization devices be verified at least weekly through the use of a biologic indicator (such as a spore testing monitor). Test results should be documented and maintained for 12 months [9]. Studies have demonstrated variability among dental practices in meeting sterilization standards. In one study, 49% of respondents did not challenge autoclaves with biological indicators. Other studies using biologic indicators found a high proportion (15% to 65%) of positive spore tests after assessing the efficacy of sterilizers used in dental offices [21].

Laboratory Areas

According to California regulations, splash shields and equipment guards should be used on dental laboratory lathes. Fresh pumice and a sterilized or new ragwheel should be used for each patient. Devices used to polish, trim, or adjust contaminated intraoral devices must be disinfected or sterilized and stored in a manner so as to prevent contamination [9].

All intraoral items, such as impressions, bite registrations, and prosthetic or orthodontic appliances, must be cleaned and disinfected with an intermediate-level disinfectant before manipulation in the laboratory and before placement in the patient's mouth. Such items should be thoroughly rinsed prior to placement in the patient's mouth [9].

Reprocessing Reusable Medical Equipment

Reusable instruments, medical devices, and equipment should be managed and reprocessed according to recommended and appropriate methods. Industry guidelines as well as equipment and chemical manufacturer recommendations should be used to develop and update reprocessing policies and procedures. Written instructions should be available for each instrument, medical device, and equipment reprocessed. The FDA has issued guidance on ensuring the safety of reusable medical devices [23].

All procedures involving blood or OPIM must be performed in such a manner as to minimize splashing, spraying, spattering, and generation of droplets of these substances. Splatter shields should be used on medical equipment associated with risk-prone procedures.

Equipment that may become contaminated with blood or OPIM must be examined before servicing or shipping and should be decontaminated as necessary, unless the employer can demonstrate that decontamination of such equipment or portions of such equipment is not feasible. A readily observable label should be attached to the equipment stating which portions remain contaminated. The employer must ensure that this information is conveyed to all affected employees, the servicing representative, and the manufacturer before handling, servicing, or shipping, so appropriate precautions may be taken.

Single-Use Devices

A single-use device is a device that is intended for use on a single patient during a single procedure. An unused single-use device is referred to as an original device. A reprocessed single-use device is an original device that has previously been used on a patient and has been subjected to additional processing and manufacturing for the purpose of an additional single use on a patient [22].

Dental Unit Waterlines, Biofilm, and Water Quality

Studies have shown that dental unit waterlines, such as narrow-bore plastic tubing that carries water to high-speed handpieces, air/water syringes, and ultrasonic scalers, can become colonized with micro-organisms, including bacteria, fungi, and protozoa. Protected by a polysaccharide layer known as a glycocalyx, these micro-organisms colonize and replicate on the interior surfaces of the tubing and form a biofilm. This biofilm serves as a reservoir that can increase the number of micro-organisms in the water used during dental treatment [10].

California regulations require that dental unit water lines be anti-retractive, to prevent patient material, such as oral micro-organisms, blood, and saliva, from entering a dental water system during treatment. These dental unit lines and devices should be purged with air or flushed with water at the beginning of the clinic day for at least two minutes prior to attaching handpieces, scalers, air water syringe tips, or other devices [9]. The dental unit lines and devices should be flushed between each patient for a minimum of 20 seconds [9]. Commercial devices and procedures shown to improve the quality of water used in dental treatment include self-contained water systems with chemical treatment, in-line microfilters, and combinations of these treatments. Simply using tap, distilled, or sterile water will not eliminate bacterial contamination in treatment water if biofilms in the system are not controlled. Microbial load should be less than or equal to 500 colony-forming units of heterotrophic bacteria per milliliter (≤500 CFU/mL) of water, the standard set for drinking water by the EPA [7]. Removal or inactivation of dental waterline biofilms requires use of chemical germicides. California law defines "germicide" as a chemical agent that can be used to disinfect items and surfaces based on the level of contamination. All germicides must be used in accordance with intended use and label instructions [9].

Regarding irrigation, if a surgical procedure involves soft tissue or bone, California regulations require the use of sterile coolants or irrigants, delivered using a sterile delivery system [9]. In addition, a new infection control standard that took effect in 2019, requires that water or other methods for irrigation must be sterile or contain recognized disinfecting or antibacterial properties when performing procedures on exposed dental pulp. Appropriate oral irrigants include chlorhexidine, BioPure MTAD, and sodium hypochlorite [33]. This requirement was in response to a 2016 outbreak of mycobacterial infection from a Southern California dental clinic that led to the hospitalization of more than 60 children. The cause was determined to be bacteria introduced through water during pulpotomies [33].

CLEANING AND DISINFECTION OF ENVIRONMENTAL SURFACES

As discussed, contaminated surfaces and objects can serve as the means of transmission for potential pathogens. The transfer of a micro-organism from an environmental surface to a patient is largely via hand contact with the surface. Although hand hygiene is important to minimize the impact of this transfer, cleaning and disinfecting environmental surfaces is fundamental in reducing their potential contribution to the incidence of infections [10].

All work areas, including contact surfaces and barriers, must be maintained in a clean and sanitary condition. Employers are required to determine and implement a written schedule for cleaning and disinfection based on the location, type of surface to be cleaned, type of soil present, and tasks or procedures being performed. All equipment and environmental and working surfaces must be properly cleaned and disinfected after contact with blood or OPIM.

If non-critical items or surfaces likely to be contaminated are manufactured in a manner preventing cleaning and disinfection, they should be protected with disposable impervious barriers. Disposable barriers should be changed when visibly soiled or damaged and between patients. Products used to clean items or surfaces prior to disinfection procedures shall be clearly labeled and follow all material safety data sheet (MSDS) handling and storage instructions. Clean and disinfect all clinical contact surfaces that are not protected by impervious barriers using a CalEPA-registered, hospital grade low- to intermediate-level disinfectant after each patient. The low-level disinfectants used must be labeled effective against hepatitis B virus and HIV. Use disinfectants in accordance with the manufacturer's instructions. Clean all housekeeping surfaces (e.g., floors, walls, sinks) with a detergent and water or a CalEPA-registered, hospital-grade disinfectant. Chemical-resistant utility gloves should be worn when handling hazardous chemicals [9].

Medical Waste Management

Federal, state, and local guidelines and regulations specify the categories of medical waste subject to regulation and outline the requirements associated with treatment and disposal [9]. Regulated medical waste is defined as [10]:

- Liquid or semi-liquid blood or OPIM

- Contaminated items that would release blood or OPIM in a liquid or semi- liquid state if compressed

- Items that are caked with dried blood or OPIM capable of releasing these materials during handling

- Contaminated sharps (e.g., needles, burs, scalpel blades, endodontic files)

- Pathologic and microbiologic wastes containing blood or OPIM

Regulated medical waste accounts for only 9% to 15% of total waste in hospitals and 1% to 2% of total waste in dental offices [10]. Examples of regulated waste found in dental practice settings are solid waste soaked or saturated with blood or saliva (e.g., gauze saturated with blood after surgery), extracted teeth, surgically removed hard and soft tissues, and contaminated sharp items, such as needles, scalpel blades, and wires [10]. General medical waste, including used gloves, masks, gowns, and lightly soiled gauze or cotton rolls, may be disposed of with ordinary waste.

Regulated medical waste requires careful disposal and containment before collection and consolidation for treatment. A single, leak-resistant biohazard bag is usually adequate for containment of regulated medical wastes, provided the bag is sturdy and the waste can be discarded without contaminating the bag's exterior. Contamination or puncturing of the bag requires placement into a second biohazard bag. All bags should be securely closed for disposal.

Medical waste requiring storage should be kept in labeled, leak-proof, puncture-resistant containers under conditions that minimize or prevent foul odors. The storage area should be well-ventilated and inaccessible to pests. Any facility that generates regulated medical waste should have a regulated medical waste management plan to ensure health and environmental safety in accordance with federal, state, and local regulations [10,21].

5. TRANSMISSION-BASED PRECAUTIONS

As discussed, Transmission-Based Precautions are used in addition to Standard Precautions for patients that require additional precautions to prevent infection transmission. The three categories of Transmission-Based Precautions are Contact, Droplet, and Airborne Precautions; these categories may overlap, and more than one category may be used at a time [25].

CONTACT PRECAUTIONS

Contact Precautions are utilized for patients with known or suspected infections that represent an increased risk for contact transmission. Contact Precautions require that practitioners [24]:

- Ensure appropriate patient placement to lessen risk for other patients or employees.

- Use PPE appropriately, including gloves and a gown. Donning PPE upon room entry and properly discarding before exiting the patient room is recommended to contain pathogens.

- Use disposable or dedicated patient-care equipment such as blood pressure cuffs. If common equipment must be used for multiple patients, thoroughly clean and disinfect.

- Prioritize cleaning and disinfection of patient rooms and contact surfaces, focusing on frequently touched surfaces and equipment and objects in the immediate vicinity of the patient.

DROPLET PRECAUTIONS

Use Droplet Precautions for patients that are known or suspected to be infected with pathogens transmitted by respiratory droplets. Droplet Precautions requires that one [24]:

- Source control by putting a mask on the patient to prevent respiratory droplets from spreading.

- Ensure appropriate patient placement to lessen risk for other patients or employees.

- Use PPE appropriately, including gloves and a gown. Donning PPE upon rom entry and properly discarding before exiting the patient room is recommended to contain pathogens.

- Limit transport and movement of patients outside of the room, and if movement is necessary, instruct patient to wear a mask and follow Respiratory Hygiene/Cough Etiquette.

AIRBORNE PRECAUTIONS

Airborne Precautions are used when patients are known or suspected to be infected with pathogens transmitted by airborne or aerosol route. Airborne pathogens include TB, measles, chickenpox, and herpes zoster. Airborne Precautions require [24]:

- Source control by putting a mask on the patient to prevent respiratory droplets from spreading.

- Ensure appropriate patient placement in an airborne infection isolation room (AIIR) constructed according to the CDC's Guideline for Isolation Precautions. In settings where Airborne Precautions cannot be implemented due to limited engineering resources, masking the patient and placing the patient in a private room with the door closed will reduce the likelihood of airborne transmission until the patient is either transferred to a facility with an AIIR or returned home.

- Restrict susceptible healthcare personnel from entering the room of patients known or suspected to have measles, chickenpox, disseminated zoster, or smallpox if other immune healthcare personnel are available.

- Use PPE appropriately, including a fit- tested NIOSH-approved N95 or higher level respirator for healthcare personnel.

- Limit transport and movement of patients outside of the room, and if movement is necessary, instruct patient to wear a surgical mask and observe Respiratory Hygiene/Cough Etiquette. Healthcare personnel transporting patients who are on Airborne Precautions do not need to wear a mask or respirator during transport if the patient is wearing a mask and infectious skin lesions are covered.

- Immunize susceptible persons as soon as possible following unprotected contact with vaccine-preventable infections (e.g., measles, varicella, or smallpox).

6. PROTECTING DENTAL HEALTHCARE WORKERS

Protecting DHCP is an integral part of every dental organization's general program for infection prevention and control. The objectives usually include [5]:

- Educating personnel about the principles of infection control and emphasizing individual responsibility

- Providing care to personnel for work-related illnesses or exposures

- Identifying work-related infection risks and implementing appropriate preventive measures

- Containing costs by preventing infectious diseases that result in absenteeism and disability

OCCUPATIONAL EXPOSURES

An occupational exposure is defined as a percutaneous injury or contact of mucous membrane or nonintact skin with blood, tissue, or OPIM, most commonly a needlestick injury. The risk of infection depends on several factors, including [27]:

- Whether the exposure was from a hollow-bore needle or other sharp instrument

- Whether the exposure was to non- intact skin or mucous membranes

- The amount of blood involved

- The amount of contagion present in the source person's blood

If a sharps injury occurs, wash the exposed area with soap and water. Do not "milk" or squeeze the wound. There is no evidence that using antiseptics will reduce the risk of transmission for any bloodborne pathogens; however, the use of antiseptics is not contraindicated. In the event that the wound needs suturing, emergency treatment should be obtained. The risk of contracting HIV from this type of exposure is extremely rare. There are no documented cases of a dental healthcare professional contracting HIV from an occupational exposure.

OSHA requires dental employers of an individual with an occupational exposure to a bloodborne pathogen to arrange a confidential medical evaluation and follow-up for any employee reporting an exposure incident [3]. An exposure incident is any eye, mouth, mucous membrane, nonintact skin, or other parenteral contact with blood or OPIM. Saliva in dental procedures is treated as potentially infectious material.

Following an exposure, the dental employer must refer the exposed employee to a licensed healthcare professional who can provide information and counseling and discuss how to prevent further spread of a potential infection. The exposed employee is entitled to appropriate follow-up and evaluation of any reported illness to determine if the symptoms may be related to HIV or hepatitis B or C infection [27].

Prompt response is necessary whenever an occupational exposure occurs. If possible, the patient should be interviewed to determine if any risk factors or bloodborne pathogens not previously disclosed are present. The patient may be tested along with the employee, if he or she agrees, in order to obtain the most information possible. Testing and postexposure prophylaxis may be conducted at an occupational injury clinic. All events leading up to and after the exposure should be documented in a written report [27].

Postexposure Prophylaxis

Postexposure prophylaxis (PEP) involves the provision of medications to someone who has had a substantial exposure, usually to blood, in order to reduce the likelihood of infection. PEP is available for HIV and hepatitis B virus. Although there is no PEP recommended for hepatitis C virus, limited data indicate that antiviral therapy might be beneficial when started early in the course of infection [28]. For employees who have not received the hepatitis B vaccine series, the vaccine (and in some circumstances hepatitis B immunoglobulin) should be offered as soon as possible (within seven days) after the exposure incident. The effectiveness of hepatitis B immunoglobulin administered more than seven days after exposure is unknown. PEP has been the standard of care for healthcare providers with substantial occupational exposures since 1996 and must be provided in accordance with the recommendations of the U.S. Public Health Service [28].

TUBERCULOSIS PREVENTION

California has one of the highest incidence rates of TB in the country, primarily because of its large population of persons born outside of the United States [31]. In 2023, the TB infection rate in California was 13 times higher among non-U.S.-born individuals than among those born in the United States. The rates of TB among Asian and Black individuals born outside the United States were 43 and 28 times higher, respectively, than that of U.S.-born White persons [31].

To prevent the transmission of Mycobacterium tuberculosis in dental care settings, infection-control policies should be developed based on the community TB risk assessment and reviewed annually. The policies should include appropriate screening for latent or active TB disease in dental care providers, education about the risk for TB transmission, and provisions for detection and management of patients who have suspected or confirmed TB disease.

The CDC recommends that all dental care providers be screened for TB upon hire, using either a tuberculin skin test or blood test [10]. The California Department of Public Health recommends an initial skin or blood test; positive reactions or results should be followed up by chest x-ray. Annual testing thereafter is recommended for dental personnel, although local and/or employer policies and methods of testing (e.g., questionnaire or skin or blood test) may differ [32].

Patients with symptoms of TB should be identified by screening; dental treatment should be deferred until active TB has been ruled out or the patient is no longer infectious following treatment. The potentially active TB patient should be promptly referred to an appropriate medical setting for evaluation of possible infectiousness and should be kept in the dental care setting only long enough to arrange for referral. Standard Precautions are not sufficient to prevent transmission of active TB [24].

A diagnosis of active respiratory TB should be considered for any patient with the following symptoms:

- Coughing for more than three weeks

- Loss of appetite

- Unexplained weight loss

- Night sweats

- Bloody sputum or hemoptysis

- Hoarseness

- Fever

- Fatigue

- Chest pain

A person with latent TB (positive skin test and no symptoms) can be treated in a dental office using standard infection control precautions [26]. This person has no symptoms and cannot transmit TB to others as there are no spores in his or her sputum.

The American Dental Association recommends that all patients be asked about any history of TB or exposure to TB, including signs and symptoms and medical conditions that increase their risk for TB disease. The Health History Form, developed by the U.S. Department of Health and Human Services, can be used to ask these questions.

If a patient with suspected or confirmed infectious TB disease requires urgent dental care, that care should be provided in a setting that meets the requirements for California ATD standards and airborne infection isolation. Respiratory protection (with a fitted N95 disposable respirator) should be used while performing procedures on such patients. Standard surgical masks are not designed to protect against TB transmission [4,26].

VACCINATION

Due to increased risk of occupational exposure, the CDC strongly recommends that all healthcare workers, including dental care providers, receive immunizations as a preventive measure. While these are the recommendations from the CDC, state and local legislation and workplace regulations may or may not require these immunizations.

Hepatitis B

Cal/OSHA guidelines require that healthcare workers who perform tasks that may involve exposure to blood or bodily fluids must have hepatitis B vaccination made available to them within 10 working days of initial assignment. The employee must also be given free information about the efficacy, safety, and benefits of vaccination [30].

The hepatitis B vaccine is given in a series of three injections at 0, 1, and 6 months. If one of the injections is missed, the series does not need to be restarted. The CDC recommends if the series is interrupted, the second or third dose should be administered as soon as possible; the second and third doses should be separated by an interval of at least eight weeks [24]. No booster is necessary. Follow-up serologic testing two months after vaccination (to ensure efficacy) is recommended. The provision of employer-supplied hepatitis B vaccination may be delayed until after probable exposure for employees whose sole exposure risk is the provision of first aid.

The high risk of hepatitis B virus exposure among healthcare personnel makes it imperative that clinical dental personnel be vaccinated. Vaccination can protect both workers and patients from hepatitis B virus infection and, whenever possible, should be completed when dentists or other dental care personnel are in training [10].

Influenza

Influenza is primarily transmitted from person to person via large, virus-laden droplets generated when infected persons cough or sneeze. These large droplets can settle on the mucosal surfaces of the upper respiratory tracts of susceptible persons who are within 3 feet of infected persons. Transmission may also occur through direct contact or indirect contact with respiratory secretions, such as when touching surfaces contaminated with influenza virus and then touching the eyes, nose, or mouth. The CDC strongly recommends that all healthcare personnel, especially those who have contact with patients at high risk, who have high-risk medical conditions, or who are older than 50 years of age, receive an annual (seasonal) influenza vaccination [24].

Measles, Mumps, and Rubella (MMR)

Vaccination for measles, mumps, and rubella is typically given in a single combination vaccine. The CDC notes that, regardless of birth year, individuals should receive two doses of measles, two doses of mumps, and one dose of rubella live-virus vaccine to be considered protected. MMR is given in a series of two injections, at least 28 days apart. Because the vaccine is often combination, most individuals will receive two doses of rubella-containing vaccine, with no adverse effect [24].

Tetanus and Diphtheria (Toxoids) and Acellular Pertussis (Tdap)

Vaccination for tetanus is recommended for all DHCP, regardless of age. The CDC recommends receiving the vaccine as soon as feasible if Tdap has not already been received, and regardless of interval from the last tetanus and diphtheria (Td) immunization. Routine boosters are recommended every 10 years thereafter [24].

Varicella

The varicella-zoster virus is responsible for chickenpox and shingles. The CDC recommends the varicella-zoster vaccine for all DHCP who do not have evidence of immunity, defined as: written documentation of two doses of varicella vaccine; laboratory evidence of immunity or confirmation of disease; diagnosis or verification of acute disease by a health-care provider; or diagnosis or verification of herpes zoster by a healthcare provider. While the varicella vaccine is recommended, the CDC does note that serologic testing before vaccination is likely to be cost-effective, as 71% to 93% of adults without a history of varicella are immune [24]. Immunization is considered complete after a series of two doses, spaced four to eight weeks apart [24].

TRAINING AND EDUCATION

Dental personnel should also fulfill all federal and state requirements for infection control training. New employees, or employees being transferred into jobs involving tasks or activities with potential exposure to blood or OPIM, must receive bloodborne pathogen training before assignment to tasks in which an occupational exposure may occur. Retraining is required annually or when changes in procedures or tasks affecting occupational exposure occur. Employees should be provided access to a qualified trainer to answer questions during the training session [9,10].

7. CONCLUSION

Effective infection control techniques are critical to reducing the incidence of infections in dental facilities. Antiseptic techniques and antibiotics will kill micro-organisms, while proper hand hygiene will block their transmission. Gloves, gowns, and masks remove DHCP from the transmission cycle by protecting them from contact with micro-organisms. Transmission-Based Precautions and isolation techniques help patients avoid being vectors of transmission. Engineering controls help to make the workplace safer, while administrative controls ensure that written protocols are in place and followed. Lastly, ensuring that all DHCP are immune or vaccinated can help decrease the availability of potential hosts.

8. DENTAL BOARD OF CALIFORNIA GENERAL PROVISIONS: SECTION 1005. MINIMUM STANDARDS FOR INFECTION CONTROL

The Dental Board of California General Provisions: Section 1005. Minimum Standards for Infection Control is available online at https://govt.westlaw.com/calregs/Document/IDB85BD734C8111EC89E5000D3A7C4BC3.

Works Cited

1. U.S. Bureau of Labor Statistics. Occupational Outlook Handbook: Dentists and Similar Occupations. Available at https://www.bls.gov/ooh/healthcare/dentists.htm. Last accessed December 15, 2024.

2. Occupational Safety and Health Administration. Worker Protections Against Occupational Exposure to Infectious Diseases. Available at https://www.osha.gov/bloodborne-pathogens/worker-protections. Last accessed December 15, 2024.

3. Occupational Safety and Health Administration. Standard 1910.1030: Bloodborne Pathogens. Available athttps://www.osha.gov/ laws-regs/regulations/standardnumber/1910/1910.1030. Last accessed December 15, 2024.

4. California Department of Industrial Relations. The California Workplace Guide to Aerosol Transmissible Diseases. Available at https://www.dir.ca.gov/dosh/dosh_publications/ATD-Guide.pdf. Last accessed December 15, 2024.

5. Centers for Disease Control and Prevention. Summary of Infection Prevention Practices in Dental Settings: Basic Expectations for Safe Care. Available at https://www.cdc.gov/dental-infection-control/hcp/summary/index.html. Last accessed December 15, 2024.

6. Centers for Disease Control and Prevention. Infection Control Basics. Available at https://www.cdc.gov/infection-control/hcp/ basics/index.html. Last accessed December 15, 2024.

7. Mills SE, Porteous N, Zawada J. Dental unit water quality: Organization for Safety, Asepsis and Prevention white paper and recommendations. 2018;(1)1:1-27.

8. World Health Organization. Global Technical Consultation Report on Proposed Terminology for Pathogens that Transmit Through the Air. Geneva: World Health Organization; 2024.

9. 9.California Code of Regulations. Section 1005: Minimum Standards for Infection Control. Available at https://govt.westlaw.com/calregs/Document/IDB85BD734C8111EC89E5000D3A7C4BC3. Last accessed December 15, 2024.

10. Centers for Disease Control and Prevention. Guidelines for infection control in dental health-care settings—2003. MMWR. 2003;52(RR17):1-72.

11. World Health Organization. Five Moments for Hand Hygiene. Available at https://www.who.int/publications/m/item/five-moments-for-hand-hygiene. Last accessed December 15, 2024.

12. Centers for Disease Control and Prevention. Occupationally acquired HIV infection among health care workers–United States, 1985–2013. MMWR. 2015;63(53):1245-246.

13. Cheng HC, Peng BY, Lin ML, Chen SL. Hand hygiene compliance and accuracy in a university dental teaching hospital. J Int Med Res. 2019;47(3):1195-1201.

14. Centers for Disease Control and Prevention. Clinical Safety: Hand Hygiene for Healthcare Workers. Available at https://www.cdc.gov/handhygiene/science. Last accessed December 15, 2024.

15. Boles C, Parker J, Hallett L, Henshaw J. Current understanding and future directions for an occupational infectious disease standard. Toxicology and Industrial Health. 2020;36(9):703-710.

16. Occupational Safety and Health Administration. Bloodborne Pathogens and Needlestick Prevention: General Guidance. Available at https://www.osha.gov/bloodborne-pathogens/general. Last accessed December 15, 2024.

17. Armstrong-Novak J, Juan HY, Cooper K, et al. Healthcare personnel hand hygiene compliance: are we there yet? Curr Infect Dis Rep. 2023;25:23-129.

18. Centers for Disease Control and Prevention. Dental Infection Prevention and Control: Best Practices for Personal Protective Equipment. Available at https://www.cdc.gov/dental-infection-control/hcp/dental-ipc-faqs/personal-protective-equipment.html. Last accessed December 15, 2024.

19. United States Department of Labor. Occupational Safety and Health Administration. 1910.132—General Requirements, Personal Protective Equipment. Available at https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.132. Last accessed December 15, 2024.

20. Porter L, Sultan O, Mitchell B, Kiernan M, et al. How long do nosocomial pathogens persist on inanimate surfaces? A scoping review. J Hosp Infect. 2024;147:25-31.

21. Rutala WA, Weber DJ, the Healthcare Infection Control Practices Advisory Committee. Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 (Update: June 2024). Available at https://www.cdc.gov/infection-control/media/pdfs/Guideline-Disinfection-H.pdf. Last accessed December 15, 2024.

22. U.S. Food and Drug Administration. Reprocessing of Single-Use Devices. Available at https://www.fda.gov/medical-devices/products-and-medical-procedures/reprocessing-single-use-medical-devices-information-health-care-facilities. Last accessed December 15, 2024.

23. U.S. Food and Drug Administration. Reprocessing of Reusable Medical Devices in Health Care Settings. Available at https://www.fda.gov/medical-devices/products-and-medical-procedures/reprocessing-reusable-medical-devices. Last accessed December 15, 2024.

24. Shefer A, Atkinson W, Friedman C, et al. Immunization of health-care personnel: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2011:60(RR07):1-45.

25. Centers for Disease Control and Prevention. Transmission-Based Precautions. Available at https://www.cdc.gov/infection-control/hcp/basics/transmission-based-precautions.html. Last accessed December 15, 2024.

26. American Dental Association. Tuberculosis. Available at https://www.ada.org/resources/ada-library/oral-health-topics/tuberculosis-overview-and-dental-treatment-conside. Last accessed December 15, 2024.

27. Centers for Disease Control and Prevention. Best Practices for Occupational Exposure to Blood. Available at https://www.cdc.gov/dental-infection-control/hcp/dental-ipc-faqs/occupational-exposure.html. Last accessed December 15, 2024.

28. U.S. Public Health Service. Updated U.S. Public Health Service guidelines for the management of occupational exposures to HBV, HCV, and HIV and recommendations for postexposure prophylaxis. MMWR. 2001;50(RR11):1-52.

29. Dental Board of California. Dental Board of California. Available at https://www.dbc.ca.gov. Last accessed January 1, 2025.

30. California Department of Industrial Relations. California Code of Regulations: Title 8, Subchapter 7.16.109, Section 5193. Bloodborne Pathogens. Available at https://www.dir.ca.gov/title8/5193.html. Last accessed January 1, 2025.

31. California Department of Public Health. TB in California: 2023 Snapshot. Available at https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/TB-in-California-2023-Snapshot.aspx. Last accessed January 1, 2025.

32. California Department of Public Health. California Tuberculosis (TB) Testing Regulations for Health Care Facilities. Available at https://www.cdph.ca.gov/Programs/CHCQ/LCP/Pages/California-TB-Testing-Regulations.aspx#. Last accessed January 1, 2025.

33. California Dental Association. New Infection Control Standard for Procedures that Expose Dental Pulp. Available at https://www.cda.org/newsroom/newsroom-archives/new-infection-control-standard-for-procedures-that-expose-dental-pulp/. Last accessed January 1, 2025.

55290 • Responsibilities and Requirements of Prescribing Schedule II Opioid Drugs

Mark Rose, BS, MA, LP

www.netce.com

Copyright © 2024 NetCE, All rights reserved.

Opioid analgesic medications can bring substantial relief to patients suffering from pain. However, the inappropriate use, abuse, and diversion of prescription drugs in America, particularly prescription opioids, has increased dramatically in recent years and has been identified as a national public health epidemic. A set of clinical tools, guidelines, and recommendations are now available for prescribers who treat pain patients with opioids. By implementing these tools, clinicians can effectively address issues related to the clinical management of opioid prescribing, opioid risk management, regulations surrounding the prescribing of opioids, and problematic opioid use by patients. In doing so, healthcare professionals are more likely to achieve a balance between the benefits and risks of opioid prescribing, optimize patient attainment of therapeutic goals, and avoid the risk to patient outcome, public health, and viability of their own practice imposed by deficits in knowledge.

Table of Contents

55290 • Responsibilities and Requirements of Prescribing Schedule II Opioid Drugs

Course Overview

Audience

Accreditations & Approvals

Designations of Credit

Special Approvals

Course Objective

Learning Objectives

Faculty

Faculty Disclosure

Division Planner

Division Planner Disclosure

Director of Development and Academic Affairs

Director Disclosure Statement

About the Sponsor

Disclosure Statement

Implicit Bias in Health Care

1. INTRODUCTION

2. SCOPE OF THE PROBLEM

3. PAIN MANAGEMENT APPROACHES IN DENTISTRY

ACUTE PAIN

CHRONIC PAIN

4. CREATING A TREATMENT PLAN AND ASSESSMENT OF ADDICTION RISK

RISK ASSESSMENT TOOLS

INFORMED CONSENT AND TREATMENT AGREEMENTS

PERIODIC REVIEW AND MONITORING

CONCURRENT USE OF BENZODIAZEPINES

CONSULTATION AND REFERRAL

DOCUMENTATION

PATIENT EDUCATION ON THE USE AND DISPOSAL OF OPIOIDS

DISCONTINUING OPIOID THERAPY

5. DENTAL OFFICE PROCEDURES FOR MANAGING VULNERABLE OR SUBSTANCE USE DISORDER PATIENTS

IDENTIFICATION OF DRUG DIVERSION/SEEKING BEHAVIORS

INTERVENTIONS FOR SUSPECTED OR KNOWN ADDICTION OR DRUG DIVERSION

CONSIDERATIONS FOR PATIENTS UNDERGOING TREATMENT FOR OPIOID USE DISORDER

6. REGULATORY REQUIREMENTS FOR PRESCRIBERS AND DISPENSERS

COMPLIANCE WITH STATE AND FEDERAL LAWS

CONTROLLED SUBSTANCES LAWS/RULES

STATE-SPECIFIC LAWS AND RULES

7. CONCLUSION

8. APPENDIX: LAWS AND REGULATIONS IN CALIFORNIA

HEALTH AND SAFETY CODE

DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT

CALIFORNIA BUSINESS AND PROFESSIONS CODE

DIVISION 2. HEALING ARTS

Works Cited

55290 • Responsibilities and Requirements of Prescribing Schedule II Opioid Drugs

Education Category. Pharmacology

Release Date. 02/01/2024

Expiration Date. 01/31/2027

Course Overview

Opioid analgesic medications can bring substantial relief to patients suffering from pain. However, the inappropriate use, abuse, and diversion of prescription drugs in America, particularly prescription opioids, has increased dramatically in recent years and has been identified as a national public health epidemic. A set of clinical tools, guidelines, and recommendations are now available for prescribers who treat pain patients with opioids. By implementing these tools, clinicians can effectively address issues related to the clinical management of opioid prescribing, opioid risk management, regulations surrounding the prescribing of opioids, and problematic opioid use by patients. In doing so, healthcare professionals are more likely to achieve a balance between the benefits and risks of opioid prescribing, optimize patient attainment of therapeutic goals, and avoid the risk to patient outcome, public health, and viability of their own practice imposed by deficits in knowledge.

Audience

This course is designed for dental professionals who may alter prescribing practices or intervene to prevent drug diversion and inappropriate opioid use.

Accreditations & Approvals

NetCE Nationally Approved PACE Program Provider for FAGD/MAGD credit. Approval does not imply acceptance by any regulatory authority or AGD endorsement. 10/1/2021 to 9/30/2027 Provider ID #217994. NetCE is an ADA CERP Recognized Provider. ADA CERP is a service of the American Dental Association to assist dental professionals in identifying quality providers of continuing dental education. ADA CERP does not approve or endorse individual courses or instructors, nor does it imply acceptance of credit hours by boards of dentistry. Concerns or complaints about a CE provider may be directed to the provider or to ADA CERP at www.ada.org/cerp. NetCE is approved as a provider of continuing education by the Florida Board of Dentistry, Provider #50-2405. NetCE is a Registered Provider with the Dental Board of California. Provider Number RP3841. Completion of this course does not constitute authorization for the attendee to perform any services that he or she is not legally authorized to perform based on his or her license or permit type. NetCE is accredited by the International Accreditors for Continuing Education and Training (IACET). NetCE complies with the ANSI/IACET Standard, which is recognized internationally as a standard of excellence in instructional practices. As a result of this accreditation, NetCE is authorized to issue the IACET CEU.

Designations of Credit

NetCE designates this activity for 2 continuing education credits. AGD Subject Code 346. This course meets the Dental Board of California's requirements for 2 unit(s) of continuing education. Dental Board of California course #02-3841-26409. NetCE is authorized by IACET to offer 0.2 CEU(s) for this program.

Special Approvals

This course fulfills the California requirement for 2 hours of education on responsibilities and requirements of prescribing Schedule II opioids.

Course Objective

The purpose of this course is to provide dental professionals who prescribe or distribute opioids with an appreciation for the complexities of opioid prescribing and the dual risks of litigation due to inadequate pain control and drug diversion or misuse in order to provide the best possible patient care and to prevent a growing social problem.

Learning Objectives

Upon completion of this course, you should be able to:

1. Apply epidemiologic trends in opioid use and misuse to current practice so at-risk patient populations can be more easily identified, assessed, and treated.

2. Outline practices for pain management in dentistry.

3. Evaluate behaviors that may indicate drug seeking or diverting as well as approaches for patients suspected of misusing opioids.

4. Discuss the regulatory requirements for prescribers and dispensers.

5. Describe the dental office procedures for managing vulnerable or substance use disorder patients.

Faculty

Mark Rose, BS, MA, LP, is a licensed psychologist in the State of Minnesota with a private consulting practice and a medical research analyst with a biomedical communications firm. Earlier healthcare technology assessment work led to medical device and pharmaceutical sector experience in new product development involving cancer ablative devices and pain therapeutics. Along with substantial experience in addiction research, Mr. Rose has contributed to the authorship of numerous papers on CNS, oncology, and other medical disorders. He is the lead author of papers published in peer-reviewed addiction, psychiatry, and pain medicine journals and has written books on prescription opioids and alcoholism published by the Hazelden Foundation. He also serves as an Expert Advisor and Expert Witness to law firms that represent disability claimants or criminal defendants on cases related to chronic pain, psychiatric/substance use disorders, and acute pharmacologic/toxicologic effects. Mr. Rose is on the Board of Directors of the Minneapolis-based International Institute of Anti-Aging Medicine and is a member of several professional organizations.

Faculty Disclosure

Contributing faculty, Mark Rose, BS, MA, LP, has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Division Planner

Mark J. Szarejko, DDS, FAGD

Division Planner Disclosure

The division planner has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Director of Development and Academic Affairs

Sarah Campbell

Director Disclosure Statement

The Director of Development and Academic Affairs has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

About the Sponsor

The purpose of NetCE is to provide challenging curricula to assist healthcare professionals to raise their levels of expertise while fulfilling their continuing education requirements, thereby improving the quality of healthcare.

Our contributing faculty members have taken care to ensure that the information and recommendations are accurate and compatible with the standards generally accepted at the time of publication. The publisher disclaims any liability, loss or damage incurred as a consequence, directly or indirectly, of the use and application of any of the contents. Participants are cautioned about the potential risk of using limited knowledge when integrating new techniques into practice.

Disclosure Statement

It is the policy of NetCE not to accept commercial support. Furthermore, commercial interests are prohibited from distributing or providing access to this activity to learners.

Implicit Bias in Health Care

The role of implicit biases on healthcare outcomes has become a concern, as there is some evidence that implicit biases contribute to health disparities, professionals' attitudes toward and interactions with patients, quality of care, diagnoses, and treatment decisions. This may produce differences in help-seeking, diagnoses, and ultimately treatments and interventions. Implicit biases may also unwittingly produce professional behaviors, attitudes, and interactions that reduce patients' trust and comfort with their provider, leading to earlier termination of visits and/or reduced adherence and follow-up. Disadvantaged groups are marginalized in the healthcare system and vulnerable on multiple levels; health professionals' implicit biases can further exacerbate these existing disadvantages.

Interventions or strategies designed to reduce implicit bias may be categorized as change-based or control-based. Change-based interventions focus on reducing or changing cognitive associations underlying implicit biases. These interventions might include challenging stereotypes. Conversely, control-based interventions involve reducing the effects of the implicit bias on the individual's behaviors. These strategies include increasing awareness of biased thoughts and responses. The two types of interventions are not mutually exclusive and may be used synergistically.

1. INTRODUCTION

Pain is the leading reason for seeking medical care, and pain management is a large part of many dental professionals' practice. Opioid analgesics are approved by the U.S. Food and Drug Administration (FDA) for moderate and severe pain and are broadly accepted in acute pain, cancer pain, and end-of-life care, but are controversial in chronic noncancer pain. In response to the long-standing neglect of severe pain, indications for opioid analgesic prescribing were expanded in the 1990s, followed by inappropriate prescribing and increasing abuse, addiction, diversion, and overdose through the 2000s. In tandem with the continued under-treatment of pain, these practice patterns led to needless suffering from uncontrolled pain, opioid analgesic addiction, and overdose. Opioid analgesic prescribing and associated overdose peaked in 2011 with both now in multi-year decline.

Patients show substantial opioid response variations in analgesia and tolerability and may exhibit a range of psychological, emotional, and behavioral responses that reflect inadequate pain control, an emerging opioid use problem, or both. Clinician delivery of best possible care to patients with pain requires appreciation of the complexities of opioid prescribing and the dual risks of inadequate pain control and inappropriate use, drug diversion, or overdose. A foundation for appropriate opioid prescribing is the understanding of factual data that clarify the prevalence, causality, and prevention of serious safety concerns with opioid prescribing.

2. SCOPE OF THE PROBLEM

Inappropriate opioid analgesic prescribing for pain is defined as the non-prescribing, inadequate prescribing, excessive prescribing, or continued prescribing despite evidence of ineffectiveness of opioids [1]. Appropriate opioid prescribing is essential to achieve pain control; to minimize patient risk of abuse, addiction, and fatal toxicity; and to minimize societal harms from diversion. The foundation of appropriate opioid prescribing is thorough patient assessment, treatment planning, and follow-up and monitoring. Essential for proper patient assessment and treatment planning is comprehension of the clinical concepts of opioid abuse and addiction, their behavioral manifestations in patients with pain, and how these potentially problematic behavioral responses to opioids both resemble and differ from physical dependence and pseudo-dependence. Prescriber knowledge deficit has been identified as a key obstacle to appropriate opioid prescribing and, along with gaps in policy, treatment, attitudes, and research, contributes to widespread inadequate treatment of pain [2].

The extent of opioid analgesic use in the United States in the 2000s was unprecedented in the country's history and unparalleled anywhere in the world. Before 1990, physicians in the United States were skeptical of prescribing opioids for chronic noncancer pain. In 2017, 20% of adults are prescribed an opioid such as oxycodone and hydrocodone for chronic pain, and sales of opioid analgesics totaled approximately $7 billion in 2016 [10,33].

Worldwide consumption of opioid analgesics has increased dramatically in the past few decades, with the United States driving a substantial proportion of this increase. For example, the 1990 global consumption of hydrocodone was 4 tons (3,628 kg), compared with the 2009 consumption of 39 tons (35,380 kg); 99% of this was consumed in the United States. Similarly, 3 tons (2,722 kg) of oxycodone were consumed globally in 1990, versus 77 tons (69,853 kg) in 2009, of which 62 tons (56,245 kg or 81%) were consumed in the United States [3]. With only 4.5% of the world's population, the United States annually consumes more than 80% of all opioid supplies, including [4]:

- 99% of all hydrocodone

- 80% of all oxycodone

- 58% of all methadone

- 54% of all hydromorphone

- 49% of all fentanyl

- 43% of all meperidine

This disproportionate rate of opioid consumption reflects sociocultural and economic factors and standards of clinical medicine.

Before it was halted in 2011, the Drug Abuse Warning Network (DAWN) provided estimates of the health consequences of nonmedical use of individual drugs, including opioid medications [6]. DAWN indicates that opioid abuse is a growing problem in the United States. In 2005 and 2011, hydrocodone and its combinations accounted for 51,225 and 97,183 emergency department visits, respectively. Oxycodone and its combinations resulted in 42,810 visits to the emergency department in 2005; this number increased to 175,229 visits in 2011 [7,8]. Visits for nonmedical use of all opioids increased from 217,594 to 420,040 during the six-year period. In 2016–2017, there were 127,101 nonmedical opioid emergency department visits [39]. While this number is an improvement from previous years, nonmedical use accounts for 47.6% of all emergency department visits related to opioids [39].

A 2018 study found that dentists prescribe 8.6% of all opioids in the United States [5]. Dentists and other oral health practitioners have a key role in effectively managing acute pain conditions, including mild postoperative pain resulting from a simple dental extraction, in addition to chronic maxillofacial pain.

3. PAIN MANAGEMENT APPROACHES IN DENTISTRY

Dental professionals should know the best clinical practices in opioid prescribing, including the associated risks of opioids, approaches to the assessment of pain and function, and pain management modalities. Pharmacologic and nonpharmacologic approaches should be used on the basis of current knowledge in the evidence base or best clinical practices. Patients with moderate-to-severe chronic pain who have been assessed and treated, over a period of time, with non-opioid therapy or nonpharmacologic pain therapy without adequate pain relief, are considered to be candidates for a trial of opioid therapy [9,10]. Initial treatment should always be considered individually determined and as a trial of therapy, not a definitive course of treatment [11].

In 2022, the CDC published an updated guideline for the prescription of opioids to manage all types of pain [34]. The updated clinical practice guideline is intended to achieve improved communication between clinicians and patients about the risks and benefits of pain treatment, including opioid therapy for pain; improved safety and effectiveness for pain treatment, resulting in improved function and quality of life for patients experiencing pain; and a reduction in the risks associated with long-term opioid therapy, including opioid use disorder, overdose, and death [34]. It is important to remember that inappropriately limiting necessary opioid medications to address patients' pain can be damaging and should be avoided.

ACUTE PAIN

Long-term opioid use often begins with treatment of acute pain. Many acute pain conditions can be managed most effectively with nonopioid medications. Nonsteroidal anti-inflammatory drugs (NSAIDs) have been found to be more effective than opioids for surgical dental pain, and the American Dental Association recommends NSAIDs as first-line treatment for acute dental pain management [5].

When opioids are used for acute pain, dentists should prescribe the lowest effective dose of immediate-release opioids in a quantity no greater than that needed for the expected duration of severe pain. In most cases, three days or less will be sufficient; more than seven days will rarely be needed [10]. However, it is important to note that this guideline is based on emergency department prescribing guidelines for non-traumatic non-surgical pain [12]. It may be necessary to prescribe for longer periods in patients with acute severe pain.

With postoperative, acute, or intermittent pain, analgesia often requires frequent titration, and the two- to four-hour analgesic duration with short-acting hydrocodone, morphine, and oxycodone is more effective than extended-release formulations. Short-acting opioids are also recommended in patients who are medically unstable or with highly variable pain intensity [13,14,15].

CHRONIC PAIN

If opioids are used, they should be combined with nonpharmacologic therapy and non-opioid pharmacologic therapy, as appropriate. Clinicians should consider opioid therapy only if expected benefits for pain and function are anticipated to outweigh risks to the patient [10].

Opioid therapy for chronic pain should be presented as a trial for a pre-defined period (e.g., ≤30 days). The goals of treatment should be established with all patients prior to the initiation of opioid therapy, including reasonable improvements in pain, function, depression, anxiety, and avoidance of unnecessary or excessive medication use [1,10]. The treatment plan should describe therapy selection, measures of progress, and other diagnostic evaluations, consultations, referrals, and therapies.

The need for frequent progress and benefit/risk assessments during the trial should be included in patient education. Patients should also have full knowledge of the warning signs and symptoms of respiratory depression. Prescribers should carefully reassess evidence of benefits and risks when increasing the dosage to ≥50 mg morphine equivalent dose (MED) per day. Decisions to titrate dose to ≥90 mg MED/day should be avoided or carefully justified [10,40].

Prescribers should be knowledgeable of federal and state opioid prescribing regulations. Issues of equianalgesic dosing, close patient monitoring during all dose changes, and cross-tolerance with opioid conversion should be considered. If necessary, treatment may be augmented, with preference for nonopioids and immediate-release opioids over long-acting/extended-release opioids. Taper opioid dose when no longer needed [16].

4. CREATING A TREATMENT PLAN AND ASSESSMENT OF ADDICTION RISK

Information obtained by patient history, physical examination, and interview, from family members, a spouse, or state prescription drug monitoring program (PDMP), and from the use of screening and assessment tools can help the clinician to stratify the patient according to level of risk for developing problematic opioid behavioral responses (Table 1[17,28]. Low-risk patients receive the standard level of monitoring, vigilance, and care. Moderate-risk patients should be considered for an additional level of monitoring and provider contact, and high-risk patients are likely to require intensive and structured monitoring and follow-up contact, additional consultation with psychiatric and addiction medicine specialists, and limited supplies of short-acting opioid formulations [10,26].

Table 1: RISK STRATIFICATION FOR PATIENTS PRESCRIBED OPIOIDS

Low Risk

Definable physical pathology with objective signs and reliable symptoms

Clinical correlation with diagnostic testing, including MRI, physical examination, and interventional diagnostic techniques

With or without mild psychological comorbidity

With or without minor medical comorbidity

No or well-defined and controlled personal or family history of alcoholism or substance abuse

Age 45 years or older

High levels of pain acceptance and active coping strategies

High motivation and willingness to participate in multimodal therapy and attempting to function at normal levels

Medium Risk

Significant pain problems with objective signs and symptoms confirmed by radiologic evaluation, physical examination, or diagnostic interventions

Moderate psychological problems, well controlled by therapy

Moderate coexisting medical disorders that are well controlled by medical therapy and are not affected by chronic opioid therapy (e.g., central sleep apnea)

Develops mild tolerance but not hyperalgesia without physical dependence or addiction

History of personal or family history of alcoholism or substance abuse

Pain involving more than three regions of the body

Defined pathology with moderate levels of pain acceptance and coping strategies

Willing to participate in multimodal therapy, attempting to function in normal daily life

High Risk

Widespread pain without objective signs and symptoms

Pain involving more than three regions of the body

Aberrant drug-related behavior

History of alcoholism or drug misuse, abuse, addiction, diversion, dependency, tolerance, or hyperalgesia

Major psychological disorders

Age younger than 45 years

HIV-related pain

High levels of pain exacerbation and low levels of coping strategies

Unwilling to participate in multimodal therapy, not functioning close to a near normal lifestyle

HIV = human immunodeficiency syndrome, MRI = magnetic resonance imaging.

Source: [17,28]

Before deciding to prescribe an opioid analgesic, clinicians should perform and document a detailed patient assessment that includes [1]:

- Pain indications for opioid therapy

- Nature and intensity of pain

- Past and current pain treatments and patient response

- Comorbid conditions

- Pain impact on physical and psychological function

- Social support, housing, and employment

- Home environment (i.e., stressful or supportive)

- Pain impact on sleep, mood, work, relationships, leisure, and substance use

- Patient history of physical, emotional, or sexual abuse

Evidence Based Practice Recommendation

Despite limited evidence for reliability and accuracy, screening for opioid use is recommended by the American Society of Interventional Pain Physicians, as it will identify opioid abusers and reduce opioid abuse.

https://painphysicianjournal.com/2012/july/2012;%2015;S67-S116.pdf

Last Accessed: January 24, 2024

Level of Evidence: Limited (Evidence is insufficient to assess effects on health outcomes because of limited number or power of studies, large and unexplained inconsistency between higher-quality trials, important flaws in trial design or conduct, gaps in the chain of evidence, or lack of information on important health outcomes.)

If substance abuse is active, in remission, or in the patient's history, consult an addiction specialist before starting opioids [1]. In active substance abuse, do not prescribe opioids until the patient is engaged in treatment/recovery program or other arrangement made, such as addiction professional co-management and additional monitoring. When considering an opioid analgesic (particularly those that are extended-release or long-acting), one must always weigh the benefits against the risks of overdose, abuse, addiction, physical dependence and tolerance, adverse drug interactions, and accidental exposure by children [10,16].

Screening and assessment tools can help guide patient stratification according to risk level and inform the appropriate degree of structure and monitoring in the treatment plan. It should be noted that despite widespread endorsement of screening tools used to help determine patient risk level, most tools have not been extensively evaluated, validated, or compared to each other, and evidence of their reliability is poor [17,28].

RISK ASSESSMENT TOOLS

Opioid Risk Tool (ORT)

The Opioid Risk Tool (ORT) is a five-item, patient-administered assessment to help predict aberrant drug-related behavior. The ORT is also used to establish patient risk level through categorization into low, medium, or high levels of risk for aberrant drug-related behaviors based on responses to questions of previous alcohol/drug abuse, psychological disorders, and other risk factors [18].

Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R)

The Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R) is a patient-administered, 24-item screen with questions addressing history of alcohol/substance use, psychological status, mood, cravings, and stress. Like the ORT, the SOAPP-R helps assess risk level of aberrant drug-related behaviors and the appropriate extent of monitoring [18,19].

Screening Instrument or Substance Abuse Potential (SISAP)

The Screening Instrument or Substance Abuse Potential (SISAP) tool is a self-administered, five-item questionnaire addressing history developed used to predict the risk of opioid misuse. The SISAP is used to identify patients with a history of alcohol/substance abuse and improve pain management by facilitating focus on the appropriate use of opioid analgesics and therapeutic outcomes in the majority of patients who are not at risk of opioid abuse, while carefully monitoring those who may be at greater risk [18].

CAGE and CAGE-AID

The original CAGE (Cut down, Annoyed, Guilty, and Eye-opener) Questionnaire consisted of four questions designed to help clinicians determine the likelihood that a patient was misusing or abusing alcohol. These same four questions were modified to create the CAGE-AID (adapted to include drugs), revised to assess the likelihood of current substance abuse [20].

Diagnosis, Intractability, Risk, and Efficacy (DIRE) Score

The Diagnosis, Intractability, Risk, and Efficacy (DIRE) risk assessment score is a clinician-rated questionnaire that is used to predict patient compliance with long-term opioid therapy [18,21]. Patients scoring lower on the DIRE tool are poor candidates for long-term opioid analgesia.

INFORMED CONSENT AND TREATMENT AGREEMENTS

The initial opioid prescription is preceded by a written informed consent or "treatment agreement" [1]. This agreement should address potential side effects, tolerance and/or physical dependence, drug interactions, motor skill impairment, limited evidence of long-term benefit, misuse, dependence, addiction, and overdose. Informed consent documents should include information regarding the risk/benefit profile for the drug(s) being prescribed. The prescribing policies should be clearly delineated, including the number/frequency of refills, early refills, and procedures for lost or stolen medications.

The treatment agreement also outlines joint physician and patient responsibilities. The patient agrees to using medications safely, refraining from "doctor shopping," and consenting to routine urine drug testing (UDT). The prescriber's responsibility is to address unforeseen problems and prescribe scheduled refills. Reasons for opioid therapy change or discontinuation should be listed. Agreements can also include sections related to follow-up visits, monitoring, and safe storage and disposal of unused drugs.

PERIODIC REVIEW AND MONITORING

When implementing a chronic pain treatment plan that involves the use of opioids, the patient should be frequently reassessed for changes in pain origin, health, and function [1]. This can include input from family members and/or the state PDMP. During the initiation phase and during any changes to the dosage or agent used, patient contact should be increased. At every visit, chronic opioid response may be monitored according to the "5 A's" [1,23]:

- Analgesia

- Activities of daily living

- Adverse or side effects

- Aberrant drug-related behaviors

- Affect (i.e., patient mood)

Signs and symptoms that, if present, may suggest a problematic response to the opioid and interference with the goal of functional improvement include [24,29]:

- Excessive sleeping or days and nights turned around

- Diminished appetite

- Short attention span or inability to concentrate

- Mood volatility, especially irritability

- Lack of involvement with others

- Impaired functioning due to drug effects

- Use of the opioid to regress instead of re-engaging in life

- Lack of attention to hygiene and appearance

The decision to continue, change, or terminate opioid therapy is based on progress toward treatment objectives and absence of adverse effects and risks of overdose or diversion [1]. Satisfactory therapy is indicated by improvements in pain, function, and quality of life. Brief assessment tools to assess pain and function may be useful, as may UDTs. Treatment plans may include periodic pill counts to confirm adherence and minimize diversion.

Assessment Tools

VIGIL

VIGIL is the acronym for a five-step risk management strategy designed to empower clinicians to appropriately prescribe opioids for pain by reducing regulatory concerns and to give pharmacists a framework for resolving ambiguous opioid analgesic prescriptions in a manner that preserves legitimate patient need while potentially deterring diverters. The components of VIGIL are:

- Verification: Is this a responsible opioid user?

- Identification: Is the identity of this patient verifiable?

- Generalization: Do we agree on mutual responsibilities and expectations?

- Interpretation: Do I feel comfortable allowing this person to have controlled substances?

- Legalization: Am I acting legally and responsibly?

The foundation of VIGIL is a collaborative physician/pharmacist relationship [25].

Current Opioid Misuse Measure (COMM)

The Current Opioid Misuse Measure (COMM) is a 17-item patient self-report assessment designed to help clinicians identify misuse or abuse in patients being treated for chronic pain. Unlike the ORT and the SOAPP-R, the COMM identifies aberrant behaviors associated with opioid misuse in patients already receiving long-term opioid therapy [26]. Sample questions include: In the past 30 days, how often have you had to take more of your medication than prescribed? In the past 30 days, how much of your time was spent thinking about opioid medications (e.g., having enough, taking them, dosing schedule)?

Pain Assessment and Documentation Tool (PADT)

Guidelines by the CDC, the Federation of State Medical Boards (FSMB), and the Joint Commission stress the importance of documentation from both a healthcare quality and medicolegal perspective. Research has found widespread deficits in chart notes and progress documentation with patients with chronic pain receiving opioid therapy, and the Pain Assessment and Documentation Tool (PADT) was designed to address these shortcomings [46]. The PADT is a clinician-directed interview, with most sections (e.g., analgesia, activities of daily living, adverse events) consisting of questions asked of the patient. However, the potential aberrant drug-related behavior section must be completed by the physician based on his or her observations of the patient.

The Brief Intervention Tool

The Brief Intervention Tool is a 26-item, "yes-no," patient-administered questionnaire used to identify early signs of opioid abuse or addiction. The items assess the extent of problems related to drug use in several areas, including drug use-related functional impairment [22].

CONCURRENT USE OF BENZODIAZEPINES

Patients who are unable to undergo dental treatment due to excessive fear, anxiety, or phobias and who do not respond to dental behavior modification techniques require pharmacotherapy. In many cases, this involves the use of benzodiazepines, such as diazepam, triazolam, and lorazepam. However, in patients who are also prescribed opioids, there are risks. In 2019, 16% of persons who died of an opioid overdose also tested positive for benzodiazepines [44]. Combining benzodiazepines with opioids is unsafe because both classes of drug cause central nervous system depression and sedation and can decrease respiratory drive—the usual cause of overdose fatality. Both classes have the potential for drug dependence and addiction. The CDC recommends that dentists avoid prescribing benzodiazepines concurrently with opioids whenever possible [10].

CONSULTATION AND REFERRAL

It is important to seek consultation or patient referral when input or care from a pain, psychiatry, addiction, or mental health specialist is necessary. Dentists who prescribe opioids should become familiar with opioid addiction treatment options (including licensed opioid treatment programs for methadone and office-based opioid treatment for buprenorphine) if referral is needed [1].

Ideally, providers should be able to refer patients with active substance abuse who require pain treatment to an addiction professional or specialized program. In reality, these specialized resources are scarce or non-existent in many areas [1]. Therefore, each provider will need to decide whether the risks of continuing opioid treatment while a patient is using illicit drugs outweigh the benefits to the patient in terms of pain control and improved function [48].

DOCUMENTATION

As noted, documentation is a necessary aspect of all patient care, but it is of particular importance when opioid prescribing is involved. All clinicians should maintain accurate, complete, and up-to-date medical records, including all written or telephoned prescription orders for opioid analgesics and other controlled substances, all written instructions to the patient for medication use, and the name, telephone number, and address of the patient's pharmacy [1]. Good records demonstrate that a service was provided to the patient and that the service was medically necessary. Regardless of the treatment outcome, thorough medical records protect the prescriber.

PATIENT EDUCATION ON THE USE AND DISPOSAL OF OPIOIDS

Patients and caregivers should be counseled regarding the safe use and disposal of opioids. As part of its mandatory Risk Evaluation and Mitigation Strategy (REMS) for extended-release/long-acting opioids, the U.S. Food and Drug Administration (FDA) has developed a patient counseling document with information on the patient's specific medications, instructions for emergency situations and incomplete pain control, and warnings not to share medications or take them unprescribed [16]. A copy of this form may be accessed online at https://www.fda.gov/media/114694/download.

When prescribing opioids, clinicians should provide patients with the following information [16]:

- Product-specific information

- Taking the opioid as prescribed

- Importance of dosing regimen adherence, managing missed doses, and prescriber contact if pain is not controlled

- Warning and rationale to never break or chew/crush tablets or cut or tear patches prior to use

- Warning and rationale to avoid other central nervous system depressants, such as sedative-hypnotics, anxiolytics, alcohol, or illicit drugs

- Warning not to abruptly halt or reduce the opioid without physician oversight of safe tapering when discontinuing

- The potential of serious side effects or death

- Risk factors, signs, and symptoms of overdose and opioid-induced respiratory depression, gastrointestinal obstruction, and allergic reactions

- The risks of falls, using heavy machinery, and driving

- Warning and rationale to never share an opioid analgesic

- Rationale for secure opioid storage

- Warning to protect opioids from theft

- Instructions for disposal of unneeded opioids, based on product-specific disposal information

There are no universal recommendations for the proper disposal of unused opioids, and patients are rarely advised of what to do with unused or expired medications [49]. According to the FDA, most medications that are no longer necessary or have expired should be removed from their containers, mixed with undesirable substances (e.g., cat litter, used coffee grounds), and put into an impermeable, nondescript container (e.g., disposable container with a lid or a sealed bag) before throwing in the trash [50]. Any personal information should be obscured or destroyed. The FDA recommends that certain medications, including oxycodone/acetaminophen (Percocet), oxycodone (OxyContin tablets), and transdermal fentanyl (Duragesic Transdermal System), be flushed down the toilet instead of thrown in the trash [31,50]. The FDA provides a free toolkit of materials (e.g., social media images, fact sheets, posters) to raise awareness of the serious dangers of keeping unused opioid pain medicines in the home and with information about safe disposal of these medicines. The Remove the Risk Outreach toolkit is updated regularly and can be found at https://www.fda.gov/drugs/ensuring-safe-use-medicine/safe-opioid-disposal-remove-risk-outreach-toolkit[31]. Patients should be advised to flush prescription drugs down the toilet only if the label or accompanying patient information specifically instructs doing so.

The American College of Preventive Medicine has established best practices to avoid diversion of unused drugs and educate patients regarding drug disposal [49]:

- Consider writing prescriptions in smaller amounts.

- Educate patients about safe storing and disposal practices.

- Give drug-specific information to patients about the temperature at which they should store their medications. Generally, the bathroom is not the best storage place. It is damp and moist, potentially resulting in potency decrements, and accessible to many people, including children and teens, resulting in potential theft or safety issues.

- Ask patients not to advertise that they are taking these types of medications and to keep their medications secure.

- Refer patients to community "take back" services overseen by law enforcement that collect controlled substances, seal them in plastic bags, and store them in a secure location until they can be incinerated. Contact your state law enforcement agency or visit https://www.dea.gov to determine if a program is available in your area.

DISCONTINUING OPIOID THERAPY

The decision to continue or end opioid prescribing should be based on a physician-patient discussion of the anticipated benefits and risks. An opioid should be discontinued with resolution of the pain condition, intolerable side effects, inadequate analgesia, lack of improvement in quality of life despite dose titration, deteriorating function, or significant aberrant medication use [1,10].

Clinicians should provide patients physically dependent on opioids with a safely structured tapering protocol. Withdrawal is managed by the prescribing physician or referral to an addiction specialist. Patients should be reassured that opioid discontinuation is not the end of treatment; continuation of pain management will be undertaken with other modalities through direct care or referral.

As a side note, cannabis use by patients with chronic pain receiving opioid therapy has traditionally been viewed as a treatment agreement violation that is grounds for termination of opioid therapy. However, some now argue against cannabis use as a rationale for termination or substantial treatment and monitoring changes, especially considering the increasing legalization of medical use at the state level [48].

5. DENTAL OFFICE PROCEDURES FOR MANAGING VULNERABLE OR SUBSTANCE USE DISORDER PATIENTS

IDENTIFICATION OF DRUG DIVERSION/SEEKING BEHAVIORS

Research has more closely defined the location of prescribed opioid diversion into illicit use in the supply chain from the manufacturer to the distributor, retailer, and the end user (the pain patient). This information carries with it substantial public policy and regulatory implications. The 2019 National Survey on Drug Use and Health asked non-medical users of prescription opioids how they obtained their most recently used drugs [51]. Among persons 12 years of age or older, 38.6% obtained their prescription opioids from a friend or relative for free, 34.7% got them through a prescription from one doctor (vs. 17.3% in 2009–2010), 9.5% bought them from a friend or relative, and 3.2% took them from a friend or relative without asking [51]. Less frequent sources included a drug dealer or other stranger (6.5%); multiple doctors (2.0%); and theft from a doctor's office, clinic, hospital, or pharmacy (0.9%) (vs. 0.2% in 2009–2010) [51].

There are certain behaviors that are suggestive of an emerging opioid use disorder. The most suggestive behaviors are [45,47,48]:

- Selling medications

- Prescription forgery or alteration

- Injecting medications meant for oral use

- Obtaining medications from nonmedical sources

- Resisting medication change despite worsening function or significant negative effects

- Loss of control over alcohol use

- Using illegal drugs or non-prescribed controlled substances

- Recurrent episodes of:

- Prescription loss or theft

- Obtaining opioids from other providers in violation of a treatment agreement

- Unsanctioned dose escalation
−Running out of medication and requesting early refills

Behaviors with a lower level of evidence for their association with opioid misuse include [45,47,48]:

- Aggressive demands for more drug

- Asking for specific medications

- Stockpiling medications during times when pain is less severe

- Using pain medications to treat other symptoms

- Reluctance to decrease opioid dosing once stable

- In the earlier stages of treatment:

- Increasing medication dosing without provider permission

- Obtaining prescriptions from sources other than the pain provider

- Sharing or borrowing similar medications from friends/family

INTERVENTIONS FOR SUSPECTED OR KNOWN ADDICTION OR DRUG DIVERSION

There are a number of actions that prescribers and dispensers can take to prevent or intervene in cases of drug diversion. These actions can be generally categorized based on the various mechanisms of drug diversion.

Prevention is the best approach to addressing drug diversion. As noted, the most common source of nonmedical use of prescribed opioids is from a family member or friend, through sharing, buying, or stealing. To avoid drug sharing among patients, healthcare professionals should educate patients on the dangers of sharing opioids and stress that "doing prescription drugs" is the same as "using street drugs" [49]. In addition, patients should be aware of the many options available to treat chronic pain aside from opioids. To prevent theft, patients should be advised to keep medications in a private place and to refrain from telling others about the medications being used.

Communication among providers and pharmacies can help to avoid inappropriate attainment of prescription drugs through "doctor shopping." Prescribers should keep complete and up-to-date records for all controlled substance prescribing. When possible, electronic medical records should be integrated between pharmacies, hospitals, and managed care organizations [49]. If available, it is also best practice to periodically request a report from the state's prescription reporting program to evaluate the prescribing of opioids to your patients by other providers [49].

When dealing with patients suspected of drug seeking/diversion, first inquire about prescription, over-the-counter, and illicit drug use and perform a thorough examination [43,49]. Pill counting and/or UDT may be necessary to investigate possible drug misuse. Photo identification or other form of identification and social security number may be required prior to dispensing the drug, with proof of identity documented fully. If a patient is displaying suspicious behaviors, consider prescribing for limited quantities [43].

If a patient is found to be abusing prescribed opioids, this is considered a violation of the treatment agreement and the clinician must make the decision whether or not to continue the therapeutic relationship. While dentists have the option of withdrawing from a case, they should notify the patient (or authorized decision maker) long enough in advance to permit the patient to secure another care provider and facilitate transfer of care, when appropriate [42]. Patients may also be given resources and/or recommendations to help them locate a new dentist.

Patients with chronic pain found to have an ongoing substance abuse problem or addiction should be referred to a pain specialist for continued treatment. Theft or loss of controlled substances is reported to the DEA. If drug diversion has occurred, the activity should be documented and a report to law enforcement should be made [38].

CONSIDERATIONS FOR PATIENTS UNDERGOING TREATMENT FOR OPIOID USE DISORDER

Medication-assisted therapy for the treatment of opioid use disorder often includes the use of buprenorphine, which reduces withdrawal symptoms and the desire to use opioids without causing the cycle of highs and lows associated with opioid misuse. The comprehensive approach of buprenorphine combined with counseling and other behavioral therapies is often one of the most effective ways to treat opioid use disorder [27].

However, buprenorphine is highly acidic, and dental problems have been reported with orally dissolving buprenorphine-containing formulations, including increased risk for tooth decay, cavities, oral infections, and loss of teeth. These complications can be serious and have been reported even in patients with no history of dental issues. Despite these risks, buprenorphine is an important treatment option for opioid use disorder and pain, and the benefits of these medicines clearly outweigh the risks.

The American Dental Association recommends instructing patients taking oral buprenorphine therapy should be instructed to rinse their mouths 30 minutes after use of a strip/tab [30]. After one hour, patients should brush their teeth. These patients should also be instructed to adhere to good oral hygiene practices and to drink more water to combat potential xerostomia. Sugary beverages and smoking/vaping should be limited or avoided, if possible. Prescription fluoride toothpaste or trays should be considered [30].

It is also essential to consider the impact of medication-assistant opioid use disorder treatment on dental pain management. Naltrexone is an opioid antagonist and will block the action of opioids used to manage dental pain. In addition, buprenorphine/methadone therapy increases patients' tolerance for other opioids. Any dental pain management plans should take these potential issues into account.

6. REGULATORY REQUIREMENTS FOR PRESCRIBERS AND DISPENSERS

COMPLIANCE WITH STATE AND FEDERAL LAWS

In response to the rising incidence in prescription opioid abuse, addiction, diversion, and overdose since the late 1990s, the FDA has mandated opioid-specific REMS to reduce the potential negative patient and societal effects of prescribed opioids. Other elements of opioid risk mitigation include FDA partnering with other governmental agencies, state professional licensing boards, and societies of healthcare professionals to help improve prescriber knowledge of appropriate and safe opioid prescribing and safe home storage and disposal of unused medication [24].

Several regulations and programs at the state level have been enacted in an effort to reduce prescription opioid abuse, diversion, and overdose, including [37]:

- Physical examination required prior to prescribing

- Tamper-resistant prescription forms

- Pain clinic regulatory oversight

- Prescription limits

- Prohibition from obtaining controlled substance prescriptions from multiple providers

- Patient identification required before dispensing

- Immunity from prosecution or mitigation at sentencing for individuals seeking assistance during an overdose

CONTROLLED SUBSTANCES LAWS/RULES

The U.S. Drug Enforcement Administration (DEA) is responsible for formulating federal standards for the handling of controlled substances. In 2011, the DEA began requiring every state to implement electronic databases that track prescribing habits, referred to as PDMPs. Specific policies regarding controlled substances are administered at the state level [36].

According to the DEA, drugs, substances, and certain chemicals used to make drugs are classified into five distinct categories or schedules depending upon the drug's acceptable medical use and the drug's abuse or dependency potential [35]. The abuse rate is a determinate factor in the scheduling of the drug; for example, Schedule I drugs are considered the most dangerous class of drugs with a high potential for abuse and potentially severe psychological and/or physical dependence.

STATE-SPECIFIC LAWS AND RULES

Most states have established laws and rules governing the prescribing and dispensing of opioid analgesics. It is each prescriber's responsibility to have knowledge of and adhere to the laws and rules of the state in which he or she prescribes.

7. CONCLUSION

Opioid analgesic medications can bring substantial relief to patients suffering from pain. However, the inappropriate use, abuse, and diversion of prescription drugs in America, particularly prescription opioids, has increased dramatically in recent years and has been identified as a national public health epidemic. A set of clinical tools, guidelines, and recommendations are now available for prescribers who treat patients with opioids. By implementing these tools, the clinician can effectively address issues related to the clinical management of opioid prescribing, opioid risk management, regulations surrounding the prescribing of opioids, and problematic opioid use by patients. In doing so, healthcare professionals are more likely to achieve a balance between the benefits and risks of opioid prescribing, optimize patient attainment of therapeutic goals, and avoid the risk to patient outcome, public health, and viability of their own practice imposed by deficits in knowledge.

8. APPENDIX: LAWS AND REGULATIONS IN CALIFORNIA

HEALTH AND SAFETY CODE

DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT

CHAPTER 4. Prescriptions

ARTICLE 1. Requirements of Prescriptions

§11165.4.

1. A health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance shall consult the patient activity report or information from the patient activity report obtained from the CURES database to review a patient's controlled substance history for the past 12 months before prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient for the first time and at least once every six months thereafter if the prescriber renews the prescription and the substance remains part of the treatment of the patient.

2. If a health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance is not required, pursuant to an exemption described in subdivision (c), to consult the patient activity report from the CURES database the first time the health care practitioner prescribes, orders, administers, or furnishes a controlled substance to a patient, the health care practitioner shall consult the patient activity report from the CURES database to review the patient's controlled substance history before subsequently prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient and at least once every six months thereafter if the prescriber renews the prescription and the substance remains part of the treatment of the patient.

3. A health care practitioner who did not directly access the CURES database to perform the required review of the controlled substance use report shall document in the patient's medical record that they reviewed the CURES database generated report within 24 hours of the controlled substance prescription that was provided to them by another authorized user of the CURES database.

2. For purposes of this paragraph, "first time" means the initial occurrence in which a health care practitioner, in their role as a health care practitioner, intends to prescribe, order, administer, or furnish a Schedule II, Schedule III, or Schedule IV controlled substance to a patient and has not previously prescribed a controlled substance to the patient.

2. A health care practitioner shall review a patient's controlled substance history that has been obtained from the CURES database no earlier than 24 hours, or the previous business day, before the health care practitioner prescribes, orders, administers, or furnishes a Schedule II, Schedule III, or Schedule IV controlled substance to the patient.

2. The duty to consult the CURES database, as described in subdivision (a), does not apply to veterinarians or pharmacists.

3. The duty to consult the CURES database, as described in subdivision (a), does not apply to a health care practitioner in any of the following circumstances:

1. If a health care practitioner prescribes, orders, or furnishes a controlled substance to be administered to a patient in any of the following facilities or during a transfer between any of the following facilities, or for use while on facility premises:

1. A licensed clinic, as described in Chapter 1 (commencing with Section 1200) of Division 2.

2. An outpatient setting, as described in Chapter 1.3 (commencing with Section 1248) of Division 2.

3. A health facility, as described in Chapter 2 (commencing with Section 1250) of Division 2.

4. A county medical facility, as described in Chapter 2.5 (commencing with Section 1440) of Division 2.

5. Another medical facility, including, but not limited to, an office of a health care practitioner and an imaging center.

6. A correctional clinic, as described in Section 4187 of the Business and Professions Code, or a correctional pharmacy, as described in Section 4021.5 of the Business and Professions Code.

2. If a health care practitioner prescribes, orders, administers, or furnishes a controlled substance in the emergency department of a general acute care hospital and the quantity of the controlled substance does not exceed a nonrefillable seven-day supply of the controlled substance to be used in accordance with the directions for use.

3. If a health care practitioner prescribes, orders, administers, or furnishes a controlled substance to a patient as part of the patient's treatment for a surgical, radiotherapeutic, therapeutic, or diagnostic procedure and the quantity of the controlled substance does not exceed a nonrefillable seven-day supply of the controlled substance to be used in accordance with the directions for use, in any of the following facilities:

1. A licensed clinic, as described in Chapter 1 (commencing with Section 1200) of Division 2.

2. An outpatient setting, as described in Chapter 1.3 (commencing with Section 1248) of Division 2.

3. A health facility, as described in Chapter 2 (commencing with Section 1250) of Division 2.

4. A county medical facility, as described in Chapter 2.5 (commencing with Section 1440) of Division 2.

5. A place of practice, as defined in Section 1658 of the Business and Professions Code.

6. Another medical facility where surgical procedures are permitted to take place, including, but not limited to, the office of a health care practitioner.

4. If a health care practitioner prescribes, orders, administers, or furnishes a controlled substance to a patient who is terminally ill, as defined in subdivision (c) of Section 11159.2.

1. If all of the following circumstances are satisfied:

1. It is not reasonably possible for a health care practitioner to access the information in the CURES database in a timely manner.

2. Another health care practitioner or designee authorized to access the CURES database is not reasonably available.

3. The quantity of controlled substance prescribed, ordered, administered, or furnished does not exceed a nonrefillable seven-day supply of the controlled substance to be used in accordance with the directions for use and no refill of the controlled substance is allowed.

2. A health care practitioner who does not consult the CURES database under subparagraph (A) shall document the reason they did not consult the database in the patient's medical record.

6. If the CURES database is not operational, as determined by the department, or cannot be accessed by a health care practitioner because of a temporary technological or electrical failure. A health care practitioner shall, without undue delay, seek to correct the cause of the temporary technological or electrical failure that is reasonably within the health care practitioner's control.

7. If the CURES database cannot be accessed because of technological limitations that are not reasonably within the control of a health care practitioner.

8. If consultation of the CURES database would, as determined by the health care practitioner, result in a patient's inability to obtain a prescription in a timely manner and thereby adversely impact the patient's medical condition, provided that the quantity of the controlled substance does not exceed a nonrefillable seven-day supply if the controlled substance were used in accordance with the directions for use.

1. A health care practitioner who fails to consult the CURES database, as described in subdivision (a), shall be referred to the appropriate state professional licensing board solely for administrative sanctions, as deemed appropriate by that board.

2. This section does not create a private cause of action against a health care practitioner. This section does not limit a health care practitioner's liability for the negligent failure to diagnose or treat a patient.

5. All applicable state and federal privacy laws govern the duties required by this section.

6. The provisions of this section are severable. If any provision of this section or its application is held invalid, that invalidity shall not affect other provisions or applications that can be given effect without the invalid provision or application.

7. This section shall become operative on July 1, 2021, or upon the date the department promulgates regulations to implement this section and posts those regulations on its internet website, whichever date is earlier.

CALIFORNIA BUSINESS AND PROFESSIONS CODE

DIVISION 2. HEALING ARTS

CHAPTER 1. General Provisions

ARTICLE 7.5. Health Care Practitioners

§688.

1. A health care practitioner authorized to issue a prescription pursuant to Section 4040 shall have the capability to issue an electronic data transmission prescription, as defined under Section 4040, on behalf of a patient and to transmit that electronic data transmission prescription to a pharmacy selected by the patient.

1. A pharmacy, pharmacist, or other practitioner authorized under California law to dispense or furnish a prescription pursuant to Section 4040 shall have the capability to receive an electronic data transmission prescription on behalf of a patient.

2. A pharmacy, pharmacist, or other practitioner authorized under California law to dispense or furnish a prescription pursuant to Section 4040 shall not refuse to dispense or furnish an electronic data transmission prescription solely because the prescription was not submitted via, or is not compatible with, the proprietary software of the pharmacy, pharmacist, or other dispensing practitioner.

3. A pharmacy, pharmacist, or other practitioner authorized under California law to dispense or furnish a prescription pursuant to Section 4040 may decline to dispense or furnish an electronic data transmission prescription submitted via a software that fails to meet any of the following:

1. Adheres to the National Council for Prescription Drug Programs SCRIPT standard, as modified from time to time.

2. Complies with the prescription content requirements set forth in Section 4040.

3. For a controlled substance prescription, complies with Parts 1300, 1304, 1306, and 1311 of Title 21 of the Code of Federal Regulations, as amended from time to time.

4. Complies with the federal Health Insurance Portability and Accountability Act of 1996, the California Confidentiality of Medical Information Act, or the security and confidentiality requirements prescribed to by the pharmacy, pharmacist, or other practitioner authorized pursuant to Section 4040.

3. For a prescription for a controlled substance, as defined by Section 4021, generation and transmission of the electronic data transmission prescription shall comply with Parts 1300, 1304, 1306, and 1311 of Title 21 of the Code of Federal Regulations, as amended from time to time.

4. A prescription prescribed by a health care practitioner shall be issued as an electronic data transmission prescription. This subdivision shall not apply to prescriptions issued pursuant to subdivision (e).

5. Subdivision (d) shall not apply to any of the following:

1. The prescription is issued pursuant to Section 11159.2 of the Health and Safety Code.

2. An electronic data transmission prescription is unavailable due to a temporary technological or electrical failure. For purposes of this paragraph, "temporary technological or electrical failure" means failure of a computer system, application, or device, or the loss of electrical power to that system, application, or device, or any other service interruption affecting the certified electronic data transmission prescription application used to transmit the prescription.

3. The prescribing health care practitioner is issuing a prescription to be dispensed by a pharmacy located outside California.

1. The prescription is issued in a hospital emergency department or urgent care clinic and one or more of the following conditions are present:

1. The patient resides outside California.

2. The patient resides outside the geographic area of the hospital.

3. The patient is homeless or indigent and does not have a preferred pharmacy.

4. The prescription is issued at a time when a patient's regular or preferred pharmacy is likely to be closed.

2. Under any of the conditions described in subparagraph (A), a prescription shall be electronically issued but does not require electronic transmission and may be provided directly to the patient.

5. The prescription is issued by a veterinarian.

6. The prescription is for eyeglasses or contact lenses.

7. The prescription is issued by a prescribing health care practitioner serving as a volunteer in a free clinic and receives no remuneration for their services.

8. The prescribing health care practitioner and the dispenser are the same entity.

9. The prescription is issued by a prescribing health care practitioner under circumstances whereby the practitioner reasonably determines that it would be impractical for the patient to obtain substances prescribed by an electronic data transmission prescription in a timely manner, and the delay would adversely impact the patient's medical condition.

10. The prescription that is issued includes elements not covered by the latest version of the National Council for Prescription Drug Programs' SCRIPT standard, as amended from time to time.

1. The prescriber registers with the California State Board of Pharmacy in a manner and format determined by the board, stating that they meet one or more of the following criteria:

1. Their practice is located in the area of an emergency or disaster declared by a federal, state, or local government.

2. They issue 100 or fewer prescriptions per calendar year.

3. They are unable to issue electronic data transmission prescriptions due to circumstances beyond their control.

2. The prescriber shall annually submit the registration required in subparagraph (A) to the California State Board of Pharmacy and maintain documentation of the circumstances qualifying them for exemption under subparagraph (A).

3. The California State Board of Pharmacy shall post a list of prescribers meeting the requirements of subparagraph (A) on its internet website.

6. A health care practitioner who issues a prescription for a controlled substance but does not transmit the prescription as an electronic data transmission prescription shall document the reason in the patient's medical record as soon as practicable and within 72 hours of the end of the technological or electrical failure that prevented the electronic data transmission of the prescription.

1. A pharmacy that receives an electronic data transmission prescription from a prescribing health care practitioner who has issued the prescription but has not dispensed the medication to the patient shall, at the request of the patient or a person authorized to make a request on behalf of the patient, immediately transfer or forward the electronic data transmission prescription to an alternative pharmacy designated by the requester, unless one of the following applies:

1. The action would result in a violation of any state or federal law.

2. The action is not supported by the latest version of the National Council for Prescription Drug Programs SCRIPT standard, as amended from time to time.

2. If a pharmacy is prohibited from transferring or forwarding electronic data transmission prescriptions, as specified in paragraph (1), to a designated alternative pharmacy, and that prohibition is subsequently removed, then that pharmacy shall implement, within one year from the date the prohibition is removed, the necessary provisions to allow for the transferring or forwarding of an electronic data transmission prescription.

8. If a pharmacy, or its staff, is aware than an attempted transmission of an electronic data transmission prescription failed, is incomplete, or is otherwise not appropriately received, the pharmacy shall immediately notify the prescribing health care practitioner.

9. A pharmacist who receives a written, oral, or faxed prescription shall not be required to verify that the prescription properly falls under one of the exceptions in subdivision (e). Pharmacists may continue to dispense medications from legally valid written, oral, or fax prescriptions pursuant to this division.

10. A health care practitioner, pharmacist, or pharmacy who fails to meet the applicable requirements of this section shall be referred to the appropriate state professional licensing board solely for administrative sanctions, as deemed appropriate by that board. This section does not create a private right of action against a health care practitioner. This section does not limit a health care practitioner's liability for the negligent failure to diagnose or treat a patient.

11. This section shall not apply to a health care practitioner, pharmacist, or pharmacy when providing health care services to an inmate, individual on parole, or youth under the jurisdiction of the Department of Corrections and Rehabilitation.

Works Cited

1. Federation of State Medical Boards. Guidelines for the Chronic Use of Opioid Analgesics. Washington, DC: The Federation of State Medical Boards; 2017.

2. Institute of Medicine, Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, DC: The National Academies Press; 2011.

3. Kenen K, Mack K, Paulozzi L. Trends in prescriptions for oxycodone and other commonly used opioids in the United States, 2000–2010. Open Medicine. 2012;6(2)e41.

4. Owen GT, Burton AW, Schade CM, Passik S. Urine drug testing: current recommendations and best practices. Pain Physician. 2012;15:ES119-ES133.

5. Centers for Disease Control and Prevention. Dental Pain Care. Available at https://www.cdc.gov/opioids/healthcare-professionals/prescribing/dental-pain.html. Last accessed January 12, 2024.

6. Miller NS, Greenfeld A. Patient characteristics and risks factors for development of dependence on hydrocodone and oxycodone. Am J Ther. 2004;11:26-32.

7. Substance Abuse and Mental Health Services Administration. Drug Abuse Warning Network, 2006: National Estimates of Drug-Related Emergency Department Visits. Rockville, MD: U.S. Department of Health and Human Services; 2007.

8. Substance Abuse and Mental Health Services Administration. Drug Abuse Warning Network, 2011: National Estimates of Drug-Related Emergency Department Visits. Rockville, MD: Substance Abuse and Mental Health Services Administration; 2014.

9. Management of Opioid Therapy for Chronic Pain Working Group. VA/DoD Clinical Practice Guideline for Opioid Therapy for Chronic Pain. Washington, DC: Department of Veterans Affairs, Department of Defense; 2017.

10. Dowell D, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain—United States, 2016. MMWR. 2016;65(1):1-49.

11. Chou R, Fanciullo GJ, Fine PG, et al. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. 2009;10(2):113-130.

12. Centers for Disease Control and Prevention. About CDC's Opioid Prescribing Guideline. Available at https://www.cdc.gov/drugoverdose/prescribing/guideline.html. Last accessed January 12, 2024.

13. Argoff CE, Silvershein DI. A comparison of long- and short-acting opioids for the treatment of chronic noncancer pain: tailoring therapy to meet patient needs. Mayo Clin Proc. 2009;84(7):602-612.

14. McCarberg BH, Barkin RL. Long-acting opioids for chronic pain: pharmacotherapeutic opportunities to enhance compliance, quality of life, and analgesia. Am J Ther. 2001;8(3):181-186.

15. National Comprehensive Cancer Network. Adult Cancer Pain, 2021. Available at https://www.nccn.org/professionals/physician_gls/pdf/pain.pdf. Last accessed January 12, 2024.

16. U.S. Food and Drug Administration. Medication Guides: Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS). Available at https://www.fda.gov/media/79776/download. Last accessed January 12, 2024.

17. Manchikanti L, Abdi S, Atluri S, et al. American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: part 2—guidance. Pain Physician. 2012;15(3 Suppl):S67-S116.

18. Cheattle MD. Risk Assessment: Safe Opioid Prescribing Tools. Available at https://www.practicalpainmanagement.com/resource-centers/opioid-prescribing-monitoring/risk-assessment-safe-opioid-prescribing-tools. Last accessed January 12, 2024.

19. Butler SF, Budman SH, Fernandez KC, Fanciullo GJ, Jamison RN. Cross-validation of a Screener to Predict Opioid Misuse in Chronic Pain Patients (SOAPP-R). J Addict Med. 2009;3(2):66-73.

20. Singer JA. Harm Reduction: Shifting from a War on Drugs to a War on Drug-Related Deaths. Available at https://www.cato.org/policy-analysis/harm-reduction-shifting-war-drugs-war-drug-related-deaths. Last accessed January 12, 2024.

21. Fine PG, Finnegan T, Portenoy RK. Protect your patients, protect your practice: practical risk assessment in the structuring of opioid therapy in chronic pain. J Fam Pract. 2010;59(9 Suppl 2):S1-S16.

22. Katz NP. Opioid Prescribing Toolkit: A Workbook for Clinicians. New York, NY: Oxford University Press; 2010.

23. American Chronic Pain Association. ACPA– Stanford Resource Guide to Pain Management: 2020 Edition. Available at https://www.theacpa.org/wp-content/uploads/2020/03/ACPA-Resource-Guide-2020-2-26-2020.pdf. Last accessed April 22, 2021.

24. Strickland JM, Huskey A, Brushwood DB. Pharmacist-physician collaboration in pain management practice. J Opioid Manag. 2007;3:295-301.

25. Brushwood DB. Screening Controlled Substance Prescriptions for Legitimacy: The VIGIL System. Available at http://www.empaa.org/downloads/EMPAA2010/presentation/BrushwoodDavid_VIGIL_EMPAA2010.pdf. Last accessed April 22, 2021.

26. Miner J, Babitz M, Dunn A, Fondario A, Smith M. Utah Clinical Guidelines on Prescribing Opioids for Treatment of Pain. Salt Lake City, UT: Utah Department of Health; 2018.

27. U.S. Food and Drug Administration. FDA Warns About Dental Problems with Buprenorphine Medicines Dissolved in the Mouth to Treat Opioid Use Disorder and Pain. Available at https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-dental-problems-buprenorphine-medicines-dissolved-mouth-treat-opioid-use-disorder. Last accessed January 12, 2024.

28. Kaye AD, Jones MR, Kaye AM, et al. Prescription opioid abuse in chronic pain: an updated review of opioid abuse predictors and strategies to curb opioid abuse (part 2). Pain Physician. 2017;20(Supp 2):S111-S133.

29. American Society of Anesthesiologists. Opioid Abuse. Available at https://www.asahq.org/madeforthismoment/pain-management/opioid-treatment/opioid-abuse. Last accessed April 22, 2021.

30. American Dental Association. Helping Dental Professionals Identify and Support Patients with Substance Use Disorders Available at https://www.ada.org/-/media/project/ada-organization/ada/ada-org/files/resources/practice/health-and-wellness/helping_dental_professionals_identify_and_sup.pdf. Last accessed January 12, 2024.

31. Federal Drug Administration. Safe Opioid Disposal: Remove the Risk Outreach Toolkit. Available at https://www.fda.gov/drugs/ensuring-safe-use-medicine/safe-opioid-disposal-remove-risk-outreach-toolkit. Last accessed January 12, 2024.

32. Oliver J, Coggins C, Compton P, et al. American Society for Pain Management Nursing position statement: pain management in patients with substance use disorders. Pain Manage Nurs. 2012;13(3):169-183.

33. U.S. Food and Drug Administration. FDA Analysis of Long-Term Trends in Prescription Opioid Analgesic Products: Quantity, Sales, and Price Trends. Available at https://www.fda.gov/media/111695/download. Last accessed January 12, 2024.

34. Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R. CDC clinical practice guideline for prescribing opioids for pain—United States, 2022. MMWR. 2022;71(3);1-95.

35. U.S. Drug Enforcement Administration. Drug Scheduling. Available at https://www.dea.gov/drug-scheduling. Last accessed January 12, 2024.

36. Hannon K. The Prescription Drug Crisis in New York State: A Comprehensive Approach. Available at https://www.scribd.com/doc/82474334/Prescription-Drug-Abuse-Crisis-in-NYS-Comprehensive-Approach-New. Last accessed January 12, 2024.

37. American Medical Association. Code of Ethics: Opinion 1.1.5 Terminating the Patient-Physician Relationship. Available at https://www.ama-assn.org/sites/ama-assn.org/files/corp/media-browser/code-of-medical-ethics-chapter-1.pdf. Last accessed January 12, 2024.

38. U.S. Department of Health and Human Services Drug Diversion: What Is a Prescriber's Role in Preventing the Diversion of Prescription Drugs? Available at https://www.hhs.gov/guidance/document/drug-diversion-what-prescribers-role-preventing-diversion-prescription-drugs. Last accessed January 12, 2024.

39. Lovegrove MC, Dowell D, Geller AI, et al. US emergency department visits for acute harms from prescription opioid use, 2016–2017. Am J Pub Health. 2019;109:784-791.

40. Centers for Disease Control and Prevention. CDC Advises Against Misapplication of the Guideline for Prescribing Opioids for Chronic Pain. Available at https://www.cdc.gov/media/releases/2019/s0424-advises-misapplication-guideline-prescribing-opioids.html. Last accessed January 12, 2024.

41. Loeser JD, Schatman ME. Chronic pain management in medical education: a disastrous omission. Postgrad Med. 2017;129(3):332-335.

42. Donovan DM, Ingalsbe MH, Benbow J, Daley DC. 12-step interventions and mutual support programs for substance use disorders: an overview. Soc Work Public Health. 2013;28(3-4):313-332.

43. U.S. Department of Justice Office of Diversion Control. Don't Be Scammed By A Drug Abuser. Available at https://www.deadiversion.usdoj.gov/pubs/brochures/drugabuser.htm. Last accessed January 12, 2024.

44. National Institute on Drug Abuse. Benzodiazepines and Opioids. Available at https://www.drugabuse.gov/drugs-abuse/opioids/benzodiazepines-opioids. Last accessed January 12, 2024.

45. Holliday S, Hayes C, Dunlop A. Opioid use in chronic non-cancer pain. Part 2: prescribing issues and alternatives. Australian Family Physician. 2013;42:104-111.

46. Passik SD, Kirsh KL, Whitcomb L, et al. A new tool to assess and document pain outcomes in chronic pain patients receiving opioid therapy. Clin Ther. 2004;26:552-561.

47. Passik SD. Issues in long-term opioid therapy: unmet needs, risks, and solutions. Mayo Clin Proc. 2009;84:593-601.

48. National Institute on Drug Abuse. Minimizing the Misuse of Prescription Opioids in Patients with Chronic Nonmalignant Pain. Available at https://www.drugabuse.gov/nidamed/centers-excellence/resources/minimizing-misuse-prescription-opioids-in-patients-chronic-nonmalignant-pain. Last accessed January 12, 2024.

49. American College of Preventive Medicine. Use, Abuse, Misuse and Disposal of Prescription Pain Medication Patient Guide. Available at http://www.yuma.usmc-mccs.org/mccsyuma/assets/File/Drug%20Facts%20Sheets/painmedsclinicalreference.pdf. Last accessed January 12, 2024.

50. U.S. Food and Drug Administration. Disposal of Unused Medicines: What You Should Know. Available at https://www.fda.gov/drugs/safe-disposal-medicines/disposal-unused-medicines-what-you-should-know. Last accessed January 12, 2024.

51. Substance Abuse and Mental Health Services Administration. Results from the 2019 National Survey on Drug Use and Health: Detailed Tables. Available at https://www.samhsa.gov/data/report/2019-nsduh-detailed-tables. Last accessed January 12, 2024.

52. Evidence-Based Practice Recommendations Citation

53. Manchikanti L, Abdi S, Atluri S, et al. American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: part 2—guidance. Pain Physician. 2012;15(3 Suppl):S67-S116. Available at https://painphysicianjournal.com/2012/july/2012;%2015;S67-S116.pdf. Last accessed January 24, 2024.

51914 • Dental Care for Patients with Disabilities

Mark J. Szarejko, DDS, FAGD

www.netce.com

Copyright © 2025 NetCE, All rights reserved.

The ability to maintain optimal oral health requires daily attention to oral hygiene and regular dental evaluations. The oral environment has a complex composition of microbial organisms and any alteration in this environment, from systemic illness, treatments, or poor oral hygiene, can result in short- and long-term oral effects. Even patients with ideal physical and mental health can be challenged in their pursuit of optimal oral health. Patients with complicated medical and/or mental health problems have a greater incidence of acute and chronic oral health problems because many are unable to perform the basic tasks necessary for fundamental oral hygiene. This is compounded by the fact that some systemic diseases and medications used in their treatment have a higher predilection for adverse oral effects. Immunosuppression, whether the result of diseases such as human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) or pharmacologic induction via chemotherapy or immunosuppressive therapy, can allow resident oral microflora to achieve pathogenic status. This course will highlight the systemic diseases and mental health issues with direct and/or indirect influence on the oral and maxillofacial complex. Suggestions to improve oral hygiene and to facilitate dental appointments will also be included.

Table of Contents

51914 • Dental Care for Patients with Disabilities

Course Overview

Audience

Accreditations & Approvals

Designations of Credit

Course Objective

Learning Objectives

Faculty

Faculty Disclosure

Director of Development and Academic Affairs

Director Disclosure Statement

About the Sponsor

Disclosure Statement

Implicit Bias in Health Care

1. INTRODUCTION

2. AUTOIMMUNE DISEASES

SJÖGREN DISEASE

LUPUS ERYTHEMATOSUS

3. IMMUNOSUPPRESSIVE CONDITIONS

HIV/AIDS

ORGAN AND BONE MARROW TRANSPLANTATION

4. DISEASES AND CONDITIONS AFFECTING NEUROMUSCULAR COORDINATION

PARKINSON DISEASE

CEREBRAL PALSY

SPINAL CORD INJURIES

STROKE

5. CONDITIONS CAUSING COGNITIVE IMPAIRMENT

DOWN SYNDROME

ALZHEIMER DISEASE

6. CONCLUSION

Works Cited

Evidence-Based Practice Recommendations Citations

51914 • Dental Care for Patients with Disabilities

Education Category. Community Health

Release Date. 05/01/2025

Expiration Date. 04/30/2028

Course Overview

The ability to maintain optimal oral health requires daily attention to oral hygiene and regular dental evaluations. The oral environment has a complex composition of microbial organisms and any alteration in this environment, from systemic illness, treatments, or poor oral hygiene, can result in short- and long-term oral effects. Even patients with ideal physical and mental health can be challenged in their pursuit of optimal oral health. Patients with complicated medical and/or mental health problems have a greater incidence of acute and chronic oral health problems because many are unable to perform the basic tasks necessary for fundamental oral hygiene. This is compounded by the fact that some systemic diseases and medications used in their treatment have a higher predilection for adverse oral effects. Immunosuppression, whether the result of diseases such as human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) or pharmacologic induction via chemotherapy or immunosuppressive therapy, can allow resident oral microflora to achieve pathogenic status. This course will highlight the systemic diseases and mental health issues with direct and/or indirect influence on the oral and maxillofacial complex. Suggestions to improve oral hygiene and to facilitate dental appointments will also be included.

Audience

This course is designed for dental professionals involved in assessing and promoting optimum oral care for special needs patients.

Accreditations & Approvals

NetCE Nationally Approved PACE Program Provider for FAGD/MAGD credit. Approval does not imply acceptance by any regulatory authority or AGD endorsement. 10/1/2021 to 9/30/2027 Provider ID #217994. NetCE is an ADA CERP Recognized Provider. ADA CERP is a service of the American Dental Association to assist dental professionals in identifying quality providers of continuing dental education. ADA CERP does not approve or endorse individual courses or instructors, nor does it imply acceptance of credit hours by boards of dentistry. Concerns or complaints about a CE provider may be directed to the provider or to ADA CERP at www.ada.org/cerp. NetCE is approved as a provider of continuing education by the Florida Board of Dentistry, Provider #50-2405. NetCE is a Registered Provider with the Dental Board of California. Provider Number RP3841. Completion of this course does not constitute authorization for the attendee to perform any services that he or she is not legally authorized to perform based on his or her license or permit type.

Designations of Credit

NetCE designates this activity for 5 continuing education credits. AGD Subject Code 750. This course meets the Dental Board of California's requirements for 5 unit(s) of continuing education. Dental Board of California course #05-3841-26465.

Course Objective

The purpose of this course is to focus awareness upon the difficult oral health issues that patients with disabilities face on a daily basis and to provide healthcare professionals with the necessary information to improve patients' oral and systemic health.

Learning Objectives

Upon completion of this course, you should be able to:

1. Outline the chronic oral health issues caused by Sjögren disease.

2. Describe the oral health issues associated with the systemic and discoid forms of lupus erythematosus.

3. Discuss the diverse variety of opportunistic oral infections that occur in patients with

4. Outline how immunosuppression for patients with organ and bone marrow transplants and from chemotherapy affects short-term and long-term oral health care.

5. Review oral health considerations for patients with Parkinson disease, cerebral palsy, and spinal cord injuries, and describe treatment modifications for home care and in-office dental care.

6. Identify the varying degrees of physical impairment experienced by stroke victims and techniques that allow them to maintain oral hygiene.

7. Describe the special oral health issues encountered by cognitively impaired patients, particularly those with Down syndrome or Alzheimer disease.

Faculty

Mark J. Szarejko, DDS, FAGD, received his dental degree from the State University of New York at Buffalo in 1985. He received fellowship from the Academy of General Dentistry in 1994.

Faculty Disclosure

Contributing faculty, Mark J. Szarejko, DDS, FAGD, has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Director of Development and Academic Affairs

Sarah Campbell

Director Disclosure Statement

The Director of Development and Academic Affairs has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

About the Sponsor

The purpose of NetCE is to provide challenging curricula to assist healthcare professionals to raise their levels of expertise while fulfilling their continuing education requirements, thereby improving the quality of healthcare.

Our contributing faculty members have taken care to ensure that the information and recommendations are accurate and compatible with the standards generally accepted at the time of publication. The publisher disclaims any liability, loss or damage incurred as a consequence, directly or indirectly, of the use and application of any of the contents. Participants are cautioned about the potential risk of using limited knowledge when integrating new techniques into practice.

Disclosure Statement

It is the policy of NetCE not to accept commercial support. Furthermore, commercial interests are prohibited from distributing or providing access to this activity to learners.

Implicit Bias in Health Care

The role of implicit biases on healthcare outcomes has become a concern, as there is some evidence that implicit biases contribute to health disparities, professionals' attitudes toward and interactions with patients, quality of care, diagnoses, and treatment decisions. This may produce differences in help-seeking, diagnoses, and ultimately treatments and interventions. Implicit biases may also unwittingly produce professional behaviors, attitudes, and interactions that reduce patients' trust and comfort with their provider, leading to earlier termination of visits and/or reduced adherence and follow-up. Disadvantaged groups are marginalized in the healthcare system and vulnerable on multiple levels; health professionals' implicit biases can further exacerbate these existing disadvantages.

Interventions or strategies designed to reduce implicit bias may be categorized as change-based or control-based. Change-based interventions focus on reducing or changing cognitive associations underlying implicit biases. These interventions might include challenging stereotypes. Conversely, control-based interventions involve reducing the effects of the implicit bias on the individual's behaviors. These strategies include increasing awareness of biased thoughts and responses. The two types of interventions are not mutually exclusive and may be used synergistically.

1. INTRODUCTION

In dentistry, patients with disabilities include those for whom a medical, physical, developmental, mental, or cognitive condition complicates their ability to maintain optimal levels of oral hygiene. As a result, these patients are at increased risk for caries and periodontal disease; the overall health of the oral mucosal tissues and the oral and maxillofacial complex can also deteriorate. According to some estimates, there are nearly 44.2 million people in the United States who are considered to have one or more disabilities [1]. Some of the conditions associated with patients with disabilities are also associated with the chronic health issues of the aging process. Because the older population in the United States is expected to grow from about 57.8 million in 2022 to 88.9 million by 2060, this is an area of particular concern [2].

Because a complete discussion of all debilitating conditions is not possible in this course, representative conditions with diverse origins will be described. This includes autoimmune, immunosuppressive, neurologic, and cognitive conditions. Autoimmune conditions such as Sjögren disease can decrease salivary production and cause a long-term challenge to oral health. Immunosuppression, caused by human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) or resulting from the use of certain medications, can cause opportunistic infections of bacterial, fungal, or viral origin. Patients who have Parkinson disease, cerebral palsy, or spinal cord injuries may develop neuromuscular control problems that preclude their ability to maintain basic oral hygiene. Developmental disabilities, such as Down syndrome, and acquired cognitive problems, such as Alzheimer disease, pose an ongoing challenge when maintaining oral hygiene, and caretaker assistance is usually required. Anticoagulant therapies used in the treatment of cardiovascular disease require special management when oral or periodontal surgery is required.

This course will discuss the oral effects associated with these conditions and the indirect and direct complications associated with the medications used in their treatment. Approaches to maintaining oral health, including at-home and in-office modifications, will also be outlined.

2. AUTOIMMUNE DISEASES

SJÖGREN DISEASE

Sjögren disease is a common autoimmune disorder that occurs in two different forms. Primary Sjögren disease involves the lacrimal glands (keratoconjunctivitis sicca) and the salivary glands (xerostomia). The secondary form presents with these problems and a diagnosed systemic connective tissue disease such as rheumatoid arthritis or fibromyalgia. Sjögren disease develops slowly over many years, and diagnosis is made an average of 2.8 years after the onset of symptoms [3]. It is estimated that as many as 4 million individuals in the United States have this disease, and women are nine times more likely to be affected than men [4]. While Sjögren disease can occur at any age, patients in their fourth and fifth decades of life are most frequently affected. The etiology of this autoimmune disorder is not well understood. Histopathologic examination reveals an infiltration of lymphocytes that causes chronic inflammation within the salivary glands and the lacrimal glands [5]. The secreting capacity of the salivary glands is diminished at rates that vary among patients. Similarly, the lymphocytic infiltration and subsequent proliferative epithelial response constricts the ducts. Decreased salivary production and flow results in xerostomia (dry mouth). The initiation of the syndrome is believed to be triggered by environmental factors, possibly viruses [4]. Because women are more likely to be affected, it is hypothesized that female sex hormones may influence the onset or presentation of the disease. The changes are irreversible, and with no current cure for Sjögren disease, patients are affected by numerous long-term problems of the oral and maxillofacial complex originating from xerostomia.

Problems Associated with Xerostomia

Saliva plays a critical role in the health and maintenance of the oropharyngeal region. A sustained reduction of salivary production in patients afflicted with Sjögren disease increases the risk for dental caries and opportunistic infections, such as candidiasis, and causes problems with the oral mucosa such as mucositis and glossitis. Speaking, swallowing, and eating can become difficult tasks under these circumstances.

The adequate production of saliva is an essential component in the self-cleansing action of teeth, as cariogenic bacteria are less adherent to the surfaces of teeth when a salivary layer is present, which minimizes their physical retention. Saliva also has a buffering capacity that raises the oral pH and creates a less acidic oral environment. When salivary production decreases, its buffering ability is also diminished and the oral pH is lower. The acidic oral environment that develops is more favorable to the proliferation of cariogenic bacteria [6,7].

Patients with secondary Sjögren disease who have diseases such as rheumatoid arthritis or fibromyalgia can have additional problems with the proper maintenance of their oral hygiene. Musculoskeletal conditions such as arthritis can interfere with the dexterity and coordination necessary for basic oral hygiene techniques, such as brushing and flossing. Patients with gingival recession and circumferentially exposed root surfaces have a greater surface area of vulnerable tooth surfaces exposed to this caries-prone environment.

Miscellaneous Oral Problems

The reduction of salivary production for patients with Sjögren disease causes a commensurate reduction in the salivary immunoglobulins and enzymes that act to decrease the pathogenicity of organisms of the oral microflora. Among these, overgrowth of the fungal organism Candida albicans causes candidiasis in many of these patients. This fungal organism thrives in an oral environment that is less lubricated and more acidic. Antifungal rinses such as nystatin are usually effective to treat candidiasis in patients with Sjögren disease. Cases that are unresolved require systemic antifungal therapy with agents such as fluconazole [8]. Antifungal troches that must be dissolved by the patient's saliva may be difficult for these patients to use.

In addition, it is important to remember that the acrylic bases of prostheses (e.g., partial or complete dentures) contain microscopic porosities and surface irregularities that can harbor candidal organisms. These appliances should also undergo antifungal treatment that is compatible with the materials of which they are composed. This is important to prevent reinoculation of the tissue-bearing mucosal surfaces with fungal organisms. Candidal infections recur in these patients because the oral conditions conducive to the initial outbreak do not resolve.

Dental Treatment Considerations

Dental treatment for patients with Sjögren disease involves both a proactive and preventive approach. These patients require more frequent recall appointments to evaluate their home care and to restore carious lesions that may develop between recall appointments. Oral hygiene instructions tailored to the patient's individual needs should be provided. Patients with arthritis or fibromyalgia may benefit from toothbrushes with modified handles or grips and special flossing aids to provide basic oral home care in the presence of compromised dexterity. Patients should also receive nutritional counseling that emphasizes a low-sugar diet to decrease the risk of extensive caries.

Evidence Based Practice Recommendation

The Sjögren's Foundation asserts that chlorhexidine administered by varnish, gel, or rinse may be considered in patients with Sjögren disease with dry mouth and a high root caries rate.

https://www.sjogrens.org/sites/default/files/inline-files/SF_PCG-Oral_0.pdf

Last Accessed: April 25, 2025

Strength of Recommendation: Strong

Concentrated preparations of 5,000 ppm sodium fluoride that can be applied directly to the teeth with a toothbrush or delivered via custom fluoride trays are an essential part of caries reduction; over-the-counter fluoride rinses do not provide the protection required to manage the increased risk. Sodium fluoride is preferred over stannous fluoride as the latter has a metallic taste, may cause a burning sensation, and can stain enamel [9]. Antimicrobial mouth rinses such as 0.12% chlorhexidine gluconate may be used to decrease the bacterial growth associated with caries and periodontal disease. Chlorhexidine has substantivity, the ability to adhere to the gingiva, mucosal tissues, and teeth for prolonged periods of time, which differentiates it from other commercial preparations. Patients should be advised that chlorhexidine will stain teeth and existing bonded (composite) restorations. A prophylaxis will remove the stains from the unrestored surfaces of the teeth, but stains in the bonded restorations may require their replacement.

Patients who wear complete or partial dentures may experience discomfort resulting from the decreased amount of saliva. The mucosal tissues that form the foundation for the prosthesis can become ulcerated, which can minimize or preclude their use. Commercial salivary substitutes may provide some relief, but their effects are temporary. Medications such as pilocarpine and cevimeline are cholinergic agonists and can stimulate salivary flow but only in the exocrine tissue and ducts that have not been destroyed by the autoimmune process [10]. Soft reline material may help to reduce the trauma to the desiccated oral mucosa.

In addition to the effects of the disease process, patients with Sjögren disease may be taking medications for other chronic illnesses, and many of these can cause xerostomia. Clinicians should determine if an alternative medication may be prescribed for which the side effect of xerostomia can be eliminated or reduced.

Treatment and Prognosis

As noted, there is no cure for Sjögren disease [11]. Patients with the condition will display varying degrees of morbidity and a spectrum of oral and maxillofacial complications. Among the most serious complication associated with primary Sjögren disease is the development of certain types of lymphomas [12]. Dental treatment should be centered on a preventative and proactive approach that mandates more frequent recall appointments and intensive patient involvement with their daily oral hygiene regimen. All clinicians involved in the oral health and overall physical health of these patients should strive to provide a continuity of care that minimizes the discomfort and complications of the disease and improves patients' quality of life [7].

LUPUS ERYTHEMATOSUS

Lupus occurs in several forms, the two most common being discoid lupus erythematosus (DLE) and systemic lupus erythematosus (SLE). DLE affects the skin and mucosa, usually without systemic involvement. SLE can affect multiple organs and systems and is the more serious form of the disease. The underlying basis for lupus is the formation of autoantibodies, especially to DNA and other nuclear material. The precise antigenic stimulus that initiates the formation of these autoantibodies is unknown. The deposition of the antigen-antibody complex into varied tissues and the resultant inflammatory response is the pathophysiologic basis of SLE [13].

The lesions of DLE usually occur on the face, scalp, ears, and hands. These lesions can feature an erythematous area and scales that extend into hair follicles, causing follicular plugging. Although oral lesions are not a strict identifying feature of DLE, when they do occur the buccal mucosa and palate are areas of predilection. Oral lesions associated with DLE can feature irregular white borders and telangiectasia peripheral to a small atrophic area that contains white papules [14]. A biopsy may be required to differentiate the oral lesions of DLE from malignant lesions such as squamous cell carcinoma.

As noted, SLE is more virulent than the discoid form of this disease. It primarily occurs in women of childbearing age, with a 9:1 female-to-male ratio [15]. Improved treatment modalities have increased the 10-year survival rate to greater than 85%, and the survival rate at five years is 95% [16,70]. Complications from infections, renal failure, and cardiovascular and pulmonary pathology are among the leading cause of death for these patients [17,18].

A classic cutaneous manifestation of lupus, which occurs in approximately 30% to 40% of patients, is a butterfly-shaped (malar) rash that extends over the bridge of the nose and the cheeks. The degree of erythema accompanying this rash can range considerably. Oral lesions can be non-specific and can include ulcerations, petechiae, and erythematous lesions of varied morphology.

Dental Treatment Considerations

Patients with SLE have varying degrees of systemic involvement. Necessary modifications to dental treatment and the ability of the patient to maintain good oral hygiene will depend upon the systems affected and the degree of their involvement.

As with Sjögren disease, arthritis affects many patients with SLE and may compromise the dexterity needed for brushing and flossing. Toothbrushes with modified handles and flossing aids can improve the ability of these patients to maintain proper oral hygiene. More frequent recall appointments may be needed if patients with SLE afflicted with arthritis experience persistent difficulty in basic oral hygiene techniques.

Hematologic problems may also occur with SLE. Thrombocytopenia, a condition of decreased platelet count, may be present and is a concern for oral and periodontal surgery patients. Before these procedures are initiated, the patient's most recent complete blood count values should be assessed. If the platelet count is less than 50,000/mm3, hemostasis can be compromised, and serious bleeding can occur [19].

Medications utilized in the treatment of SLE can have systemic ramifications and can require modifications for dental treatment. The salicylates and nonsteroidal anti-inflammatory drugs (NSAIDs) used to provide analgesia can also prolong the bleeding time. The degree to which this occurs may be clinically insignificant, but the synergistic effect can be a concern when considering oral or periodontal surgery for patients with SLE who experience thrombocytopenia. If an invasive dental procedure is indicated, it should be coordinated with the patient's physician.

Immunosuppressive medications such as azathioprine and cyclophosphamide are used in patients with SLE to decrease the autoimmune response that causes organ and system damage. Azathioprine can cause bone marrow suppression and decrease production of platelets and granular and agranular leukocytes [20]. If a patient with SLE takes these medications, his or her physician must be consulted before any oral or periodontal surgical procedure is begun. Concerns about postsurgical hemostasis and infections should be discussed. The dosage of this medication may need to be adjusted pending the laboratory values as determined in the complete blood count. Hepatotoxicity is also a potential effect of azathioprine. Many medications utilized in dentistry are metabolized in the liver, and their metabolism may be diminished in patients taking azathioprine, with the potential for toxic accumulation [21]. Laboratory values for liver enzymes and a liver biopsy may be required if there is any concern about diminished hepatic function. Cyclophosphamide can also cause diminished production of platelets and leukocytes, with associated concerns about hemostasis and postsurgical infections. Mucositis may also occur in some patients for whom cyclophosphamide is prescribed [22].

Systemic corticosteroid oral medications, such as prednisone and methylprednisolone, as well as injectable medications, such as dexamethasone and triamcinolone, are used in SLE patients to decrease the systemic inflammatory response and to suppress the cellular basis for the autoimmune dysfunction. Prolonged use of these medications can extend the healing time of surgical sites, increase the difficulty of detecting oral infections, and cause suppression of adrenal gland secretions. These are significant considerations before any oral or periodontal surgery is contemplated. Further, because many patients consider any dental treatment as a stressor, prolonged pharmacotherapeutic adrenal gland suppression can preclude the ability of this endocrine organ to secrete the appropriate hormones necessary for the physiologic adaptation to stress. A dose adjustment of these medications prior to dental treatment may be necessary to prevent an adrenocortical crisis. When used in conjunction with systemic corticosteroids, analgesics used for odontogenic pain, such as NSAIDs, can increase the risk of gastric ulceration. Another classification of analgesics may be needed [21].

Treatment and Prognosis

Currently, there is no cure for lupus erythematosus. Although there is no cure, there are several types of drugs available to aid in the treatment and management of secondary symptoms. Among these drug classes are NSAIDs, corticosteroids, antimalarials, and immunosuppressives. In cases of lupus-related severe kidney disease not helped by pharmacologic intervention or dialysis, kidney transplant may be necessary. The medications used to treat both forms of lupus can have numerous interactions with medications used for dental treatment and can adversely affect immunocompetence, hemostasis, and the ability to withstand stress.

3. IMMUNOSUPPRESSIVE CONDITIONS

HIV/AIDS

The oral complications discussed in this section are mainly evident when the progression of HIV infection has reached the level at which designated opportunistic illnesses and infections fulfill the criteria for the diagnosis of AIDS. Patients with AIDS encounter unique oral problems, and special considerations for their dental treatment are often necessary.

The defining characteristic of HIV disease is the immune deficiency state caused by ongoing viral replication and cell-to-cell transmission within lymphoid tissue. With chronicity of infection there is a progressive depletion of CD4 (helper-inducer) lymphocytes, the very T lymphocyte cohort whose function it is to direct other cells in the immune system, and to orchestrate the inactivation of virus antigen. The result is a depressed T lymphocyte functional capacity, characterized by depletion of helper T cells (T4), impaired killer T cell activity, and increased suppressor T cells (T8). In persons with intact lymphocyte immune systems, the normal number of CD4 T cells ranges from 600–1,200 cells/mcL.

Symptomatic illness can be expected to supervene as the CD4 count declines to a level less than 200 cells/mcL, as this correlates with severe immunodeficiency. The Centers for Disease Control and Prevention defines late-stage HIV infection as AIDS on the basis of two criteria: CD4 count less than 200 cells/mcL or a characteristic AIDS-defining illness such as pneumonia, central nervous system toxoplasmosis, or other opportunistic infections or tumors (Kaposi sarcoma). The natural history and the prognosis for the patient with chronic HIV infection have been dramatically altered by antiretroviral therapy, especially by the use of combination antiretroviral therapy (cART).

Evidence Based Practice Recommendation

According to the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America, oral fluconazole at 100 mg once per day is considered the drug of choice to treat oropharyngeal candidiasis in patients with HIV/AIDS, except during pregnancy. One to two weeks of therapy is recommended for oropharyngeal candidiasis; two to three weeks of therapy is recommended for esophageal disease.

https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-oi/guidelines-adult-adolescent-oi.pdf

Last Accessed: April 25, 2025

Strength of Recommendation/Level of Evidence: AI (Strong recommendation based on one or more randomized trials with clinical outcomes and/or validated laboratory endpoints)

Oral candidiasis is the most frequent opportunistic oral infection in patients with HIV/AIDS, with a very high occurrence in this population [23]. When C. albicans becomes an opportunistic oral pathogen, the extent and virulence of the infection increase as the CD4+ lymphocyte count decreases. Candidiasis can extend to the pharynx and esophagus and ultimately result in a fatal septic termination. Oral or intravenous antifungal medications such as fluconazole and itraconazole are used when advanced fungal infections occur. Caution must be exercised when other medications are prescribed, as antifungal medications can have numerous problematic drug-drug interactions. Invasive dental treatment should be avoided during an outbreak of oral candidiasis as surgical sites can become a means of systemic fungal dissemination.

Periodontal disease can manifest aggressively in patients with HIV/AIDS, especially those who are extremely immunocompromised. Most forms of periodontal disease progress slowly and asymptomatically. As the immunocompetence of patients with HIV/AIDS deteriorates, periodontal pathogens can accelerate the loss of soft tissue attachment and of the alveolar bone. Necrotizing gingivitis and periodontitis (previously called HIV-associated gingivitis and periodontitis) can be of such severity that loss of alveolar bone support requires the extraction of the involved teeth. Extension of the periodontal pathogens into the adjacent mucosa and bone can cause a necrotizing stomatitis, which can destroy these tissues and advance to a life-threatening infection [24]. It is critical for all HIV patients to maintain regular recall appointments during the entire course of their illness. Initial periodontal problems that can be treated conservatively with an early diagnosis will become increasingly difficult to treat and potentially refractory to periodontal treatment during the progression of the disease.

Before treatment such as oral or periodontal surgery and root planing and curettage is started, the overall health status of the patient should be assessed. The most recent laboratory results, including complete blood count, CD4+ levels, and viral load, must be known before any invasive treatment is attempted. Some patients with AIDS develop thrombocytopenia, and postsurgical hemostasis becomes an issue. Similarly, patients may develop neutropenia, in which the production of neutrophils and their role in a healthy immune system decreases. These patients can be at an increased risk of postoperative infections. The infections can become life-threatening even after basic surgical procedures. Invasive procedures may require postponement until the appropriate hematologic values are attained. Antibiotics used prophylactically and postsurgically, by oral or parenteral means, are further considerations.

As HIV progresses, there will be a point, determined by the CD4+ and viral load levels, when the patient is placed on cART. Medications from different classes of the antiretroviral drugs are combined to decrease the viral load and increase the CD4+ level; some of these medications can interact with those used in the scope of dental practice.

Acetaminophen, alone or in combination with narcotics such as codeine or hydrocodone, is frequently used to control dental and postsurgical pain. If acetaminophen is combined with zidovudine, a nucleoside reverse transcriptase inhibitor that may be included in the cART regimen, there is potential to accentuate the neutropenia and anemia caused by zidovudine. NSAIDs such as ibuprofen and naproxen are also commonly utilized to control postprocedural dental pain. These medications can alter the metabolism of the nucleotide tenofovir and can also increase the risk for renal complications [25]. When medications are prescribed for systemic diseases, clinicians have the responsibility to be cognizant of their potential interactions with medications utilized for dental treatment. Hepatic and renal diseases can alter the clearance of many medications.

Treatment and Prognosis

There is no cure for HIV/AIDS at the present time. Proactive use of cART has been successful in increasing the lifespan for these patients; however, these medications can have multiple side effects and require a significant number of pills be taken daily, which can decrease patient compliance. Dental treatment should be initiated in the earliest known stage of HIV infection, during which time dental caries, periodontal problems, and oral pathology can be treated while the patient's immune system is capable of withstanding such treatment. The frequency of recall appointments should reflect the oral health concerns and the degree of complications associated with advancing HIV disease.

ORGAN AND BONE MARROW TRANSPLANTATION

Solid organ and bone marrow transplants are being done with increasing frequency. These are complex procedures with initial and long-term challenges. Potent immunosuppressive medications are prescribed for these patients to decrease the risk of rejection of the transplant. These medications can have pronounced oral effects and can subject the patient to opportunistic oral infections, which can have significant morbidity and even result in death.

Cyclosporine (modified and nonmodified) is a commonly used immunosuppressive agent prescribed for organ transplant patients. Systemically, it can induce changes in neural, renal, and hepatic function and can cause hypertension [26,72]. Potential oral effects include gingival hyperplasia, oral ulcers, xerostomia, and increased susceptibility to opportunistic oral infections. Gingival enlargement usually occurs within the first three months of cyclosporine administration and can be potentiated by the coadministration of medications such as the calcium channel blocker nifedipine, used to treat hypertension. The hyperplasia can involve the interdental papillae and the marginal and papillary tissues [27]. These tissue changes can complicate patients' ability to maintain ideal oral hygiene and increase the incidence of periodontal disease.

Another potent immunosuppressive medication that is used for organ transplant patients is tacrolimus. The increased risk for opportunistic infections associated with cyclosporine is also a potential problem with tacrolimus. Renal toxicity, anemia, and hyperkalemia are among the other potential side effects [28]. However, the associated gingival hyperplasia and hypertension that may occur with cyclosporine are not encountered with tacrolimus.

Acute periodontal infections develop more readily, as pharmacologically induced immunosuppression can decrease the host response to periodontal pathogens. The opportunistic infections that occur with the use of medications such as cyclosporine may last longer and be more virulent than those in non-immunocompromised patients. C. albicans is a common cause of candidiasis in many post-transplant patients. Systemic antifungal agents such as ketoconazole and voriconazole are used when extensive or refractory candidiasis is not resolved with topical agents such as nystatin. These medications may increase the serum concentrations of cyclosporine and tacrolimus, so they should be only used with caution after medical consultation.

Aspergillus is another fungal species that can demonstrate a virulent and even lethal course in the immunosuppressed transplant patients. This fungal pathogen is seen in 5% of liver, lung, and heart transplant patients but is less common in kidney transplant patients [29]. Systemic antifungal medications that are effective against Aspergillus spp. include itraconazole, posaconazole, voriconazole, caspofungin, and micafungin [28,30]. The use of these medications may increase the serum levels of cyclosporine; blood levels of the immunosuppressive agent should be monitored carefully.

Oral and maxillofacial viral infections also can occur more frequently and require an extended healing period for post-transplant patients. Herpes simplex virus 1 (HSV-1) causes outbreaks of recurrent herpes labialis (cold sores). These lesions can become more expansive in immunocompromised patients and can even cause herpetic keratoconjunctivitis, which can lead to blindness. The combination of stress associated with ongoing medical issues and medically induced immunosuppression contributes to these recurrent outbreaks.

The varicella zoster virus, which causes chickenpox in children and young adults, can also be reactivated in the adult years as the herpes zoster virus, which causes shingles. Oral and maxillofacial involvement follows the distribution of the mandibular, maxillary, and ophthalmic divisions of the trigeminal nerve. These vesicular lesions can be cutaneous or intraoral and are much more extensive then than those of HSV-1. Immunosuppressed patients may have prolonged and more aggressive outbreaks of shingles. Intraoral involvement can progress to necrosis of the mucosa and alveolar bone, with tooth loss as a potential sequela.

Topical or oral antiviral agents such as acyclovir or valacyclovir can expedite the healing of recurrent herpes labialis lesions. Extensive shingles lesions may require intravenous acyclovir to promote healing. Because the immunosuppressed status of transplant patients will continue for life, viral outbreaks are likely to recur. Many patients with shingles develop a painful condition called postherpetic neuralgia (PHN) at the area where the lesions occurred. Narcotic analgesics and antidepressants are prescribed for this chronic, painful condition. If a patient has PHN and is taking these medications, prescribing additional narcotic analgesics for odontogenic pain or postsurgical analgesia should be avoided.

A special concern for transplant recipients is the increasing chance for the development of certain malignancies over time [31]. Squamous cell carcinoma (particularly occurring on the lip), basal cell carcinomas, and Kaposi sarcoma occur with increasing incidence post-transplantation [26]. The range of incidence extends from 10% 10 years after the transplant to 40% after 20 years [32]. The viral DNA of human papillomavirus (HPV) has been isolated from some of these lesions. The chronic immunosuppressive state of transplant patients may allow the HPV to have a role in the development of these lesions [33]. This potential for oral malignancies mandates that patients who have received transplants be educated regarding the necessity for regular, comprehensive oral examinations including oral and maxillofacial cancer screenings.

The first bone marrow transplant was performed in 1958 [34]. This procedure is utilized for patients afflicted with myeloproliferative disorders, including aplastic anemia, chronic myelogenous leukemia, and acute leukemia that has been refractory to chemotherapy treatment. Prior to the transplant, procedures in varied combinations such as chemotherapy, total body irradiation, and the use of immunosuppressive medications are used to kill cancer cells and to decrease the immune response that can cause rejection of the transplanted tissues. This rigorous pretreatment regimen can reactivate the herpes simplex virus in as many as 80% of patients [35]. Acyclovir is used prophylactically for bone marrow transplant patients who test positive for antibodies to herpes simplex virus.

Chemotherapy is used in conjunction with surgery and radiotherapy for varied systemic and organ-based malignancies. These medications have a low margin of safety and target rapidly dividing cells, which includes both the malignant cells and healthy cells of many tissues. The cells of the oral mucosa are rapidly dividing and may be damaged during chemotherapy. The resulting oral mucositis features painful mucosal ulcerations that can also serve as a means of systemic dissemination for oral pathogens. The alteration of the ability of the bone marrow to produce an adequate quality and quantity of platelets, erythrocytes, and granular and agranular leukocytes can make these patients prone to opportunistic infections and bleeding problems. Fortunately, these problems resolve after the cessation of chemotherapy.

Dental Treatment Considerations

A proactive course of dental treatment prior to transplant surgery and chemotherapy is mandatory to maintain optimal oral health and to prevent dental pathology from developing into problems that can become life-threatening. Patients who require an organ or a bone marrow transplant are chronically ill and may wait years before a transplant is available. The patient's physician should be consulted before any treatment is initiated; these patients are usually on several medications that can interact with those used for dental treatment. Patients with compromised liver and kidney function will have an altered ability to metabolize and excrete certain medications, such as local anesthetics, analgesics, and antibiotics. Decreased hepatic function can alter the production of coagulation factors, which can affect hemostasis for surgical procedures. Cardiac patients who are awaiting a heart transplant may be placed on anticoagulant therapy with medications such as warfarin, clopidogrel, or aspirin. NSAIDs can potentiate the anticoagulant effects of these medications and may cause internal bleeding. Alternative analgesics compatible with the patient's medical history and current medications should be utilized. When any dental procedure is planned in which hemostasis is a concern, clinicians should consult the patient's physician to obtain the most recent prothrombin time (PT) and international normalized ratio (INR).

Dental treatment should be designed to restore carious teeth or to extract those that cannot be restored or that the patient will not maintain upon their restoration. Similarly, teeth with periodontal problems that cannot be treated and maintained should be extracted. The long-term immunosuppressive concerns of transplant patients must be addressed before any invasive dental treatment is started. It is essential that surgical procedures are completed as far in advance as possible of the transplant surgery and subsequent immunosuppressive therapy. The frequency of recall appointments should reflect the patient's ability to maintain optimal oral hygiene via home care. Antibacterial mouth rinses such as 0.12% chlorhexidine gluconate can be an excellent supplement for an oral hygiene regimen that seeks to promote optimal periodontal health. Management of the patient before and after any transplant procedure should consist of patient education, motivation, and treatment that will allow the patient to achieve and maintain oral health as much as possible.

Treatment and Prognosis

Many factors can influence the survival rates of organ transplant patients. Unfortunately, many patients die waiting for a transplanted organ. The five-year survival rates for kidney and heart transplant patients are approximately 85% and 80%, respectively [36,73]. Immunosuppressive therapy can subject the patient to many systemic complications with serious and even fatal consequences. Local infections that would not be a health threat to an immunocompetent patient may be the source of a fatal septicemia for a transplant patient. The allied healthcare professionals involved in the care of these patients should promote oral and systemic health and optimize a successful convalescence and long-term survival.

4. DISEASES AND CONDITIONS AFFECTING NEUROMUSCULAR COORDINATION

PARKINSON DISEASE

Parkinson disease is a progressive neurodegenerative condition that affects more than 1 million Americans [37]. The mean age at diagnosis is 60 years. In these patients, the neurons in the substantia nigra of the brain that store and release the neurotransmitter dopamine undergo a 60% to 70% depletion. The result is impaired motor function and poorly coordinated bodily movements [38]. The extent of impairment may be staged/measured using the Hoehn and Yahr scale, which describes five stages of Parkinson disease. The categories range from stage 1, which indicates mild tremors and minimal, unilateral functional impairment, to stage 5, which is characterized by incapacitating motor symptoms that require restriction to bed or dependence upon a wheelchair for ambulation [39]. However, this staging system has been criticized for its over-reliance on physical (rather than psychologic or behavioral) symptoms. The interference with normal motor function can have varied orofacial manifestations that progressively detract from optimal oral function.

Evidence Based Practice Recommendation

The National Institute for Health and Care Excellence recommends that pharmacologic management for drooling of saliva in people with Parkinson disease should only be considered if nonpharmacologic management (e.g., speech and language therapy) is not available or has not been effective.

https://www.nice.org.uk/guidance/ng71

Last Accessed: April 25, 2025

Level of Evidence: Expert Opinion/Consensus Statement

Approximately half of patients with Parkinson disease have chronic problems with drooling [40]. Parkinson disease can affect the pharyngeal muscles and those of the tongue and the floor of the mouth, causing dysphagia (difficulty in swallowing). This condition combined with the head flexed in an anterior plane can make swallowing saliva difficult and drooling a chronic problem.

Saliva laden with the oral fungal organism C. albicans can inoculate the corners of the lips to cause angular cheilitis. This localized fungal infection can cause the lips and adjacent skin to remain cracked and inflamed for extended periods of time with subsequent pain during basic movements of the tissues. Antifungal preparations such as nystatin ointment may provide temporary relief, but angular cheilitis usually recurs in patients with Parkinson disease because its origin, chronic drooling, remains.

The progressive neurodegeneration and commensurate loss of motor skills can make wearing dentures very difficult. The maxillary denture can develop retention problems when the musculature of the soft palate, upon whose termination an adequate suction seal is dependent, undergoes tremors and spasms that destabilize the area. The mandibular denture can present as more of a challenge to the patient with Parkinson disease when the musculature of the tongue, lips, cheeks, and floor of the mouth cannot operate in unison as balancing forces. Zinc-free denture adhesives may offer some additional retention but are not able to totally counter the progressive loss of motor skills necessary for successful prosthetic function. The placement of implants for additional denture retention may be an option in the early stage of the disease. The increasing morbidity associated with advancing Parkinson disease precludes their placement during later stages. Patients who possess all or some of their teeth will face oral hygiene challenges as the disease advances and swallowing a bolus of food becomes more challenging. The cumulative effect of the extended contact time between the teeth and the food increases the risk of caries development. Tremors to the fingers decrease patients' ability to maintain optimal oral hygiene and increase the incidence of both caries and periodontal disease. An increasing frequency of recall appointments may be necessary to monitor the degree of oral hygiene impairment and implement strategies for improvement. Caregiver involvement for basic oral hygiene procedures such as brushing and flossing is usually required as the disease progresses.

Pharmacologic management of Parkinson disease includes medications that replace the depleted dopamine, potentiate the action of dopamine that is produced, or increase dopamine availability as it crosses the blood-brain barrier. The medication levodopa is transformed into dopamine by the neurons of the substantia nigra. The benefit of this medication can decrease after prolonged administration, so its use is reserved for adjunctive treatment as the disease advances. A side effect of this medication is orthostatic hypotension; after dental treatment, patients should be raised incrementally from the reclined position to an upright position to minimize the chances of postprocedural syncope. Assistance to and from the chair may be necessary. Entacapone and carbidopa are utilized for patients with Parkinson disease to increase the bioavailability of levodopa, and both can also cause orthostatic hypotension. Selegiline is also prescribed with levodopa. Because selegiline is metabolized in the liver into l-methamphetamine and l-amphetamine, its combination with other sympathomimetic substances, such as epinephrine or levonordefrin, could cause an increase in blood pressure [41]. The patient's blood pressure should be recorded before any procedure, and vasoconstrictors should be used sparingly or avoided completely.

Treatment and Prognosis

Parkinson disease is incurable, and its progression can vary considerably among patients. The illness generally progresses to complete disability and contributes to the death of affected patients despite long-term pharmacologic intervention. Preventive and interceptive dental treatment should be initiated as early as is possible for patients with Parkinson disease. Advancing disease can preclude the ability of the patient to cooperate for basic dental treatment. Cognitive impairment in the latter stages of the disease can require that consent for dental procedures be obtained from a designated representative.

CEREBRAL PALSY

It is estimated that 1 million individuals in the United States have cerebral palsy [42]. In 2006, the International Workshop on the Definition and Classification of Cerebral Palsy updated its definition of the condition, which is recognized as a group of activity-limiting disorders affecting the development of movement and posture [43]. Non-progressive disturbances that occur in the developing fetal or infant brain cause motor disorders; these can be accompanied by disorders that impair sensation, cognition, behavior, and communication [43]. Cerebral palsy is not associated with specific oral or maxillofacial lesions or abnormalities. However, several oral conditions occur within this patient population.

Periodontal disease is common in patients with cerebral palsy. The motor skills required for brushing and flossing are compromised to varying degrees, especially if cognitive and sensation disturbances accompany the motor problems, and optimal oral hygiene can be difficult to achieve and maintain. Caregivers may not be able to brush and floss the patient's teeth to a degree that allows for effective and consistent removal of bacterial plaque; the cumulative accretion of plaque may lead to gingivitis and ultimately periodontal disease. Some patients with cerebral palsy take medications to control seizures, such as phenytoin. Gingival hyperplasia has been identified as a side effect of this medication and may be exacerbated by plaque accumulation. When the surfaces of the teeth are covered by more gingival tissue, the ability to maintain plaque control becomes even more of a challenge. A gingivectomy can remove the hyperplastic tissue but recurrence with the continued use of phenytoin remains an issue.

Dental caries are more prevalent among patients with cerebral palsy as a result of the same factors that predispose patients to periodontal problems. Bacteria within accumulated plaque maintain prolonged contact with tooth surfaces and induce the development of dental caries. When the muscles of mastication and swallowing are compromised by cerebral palsy, the teeth have a prolonged exposure time to the bolus of food. This can result in an increased risk for caries. This problem is amplified when it is coupled with a patient's inability to maintain optimal oral hygiene. The irregular surfaces of unrestored carious lesions favor further accumulation of plaque and debris that perpetuate dental caries and periodontal issues.

An estimated 59% to 92% of patients with cerebral palsy have malocclusions, many of which are categorized as Angle's Class II ("buck teeth") classification [44]. Malocclusions decrease the efficiency of mastication and complicate oral hygiene, both of which can increase the risk of periodontal problems and caries. Further, protrusive teeth are more subject to traumatic dental injuries that require expensive endodontic and restorative procedures or extractions. Cerebral palsy is not an absolute contraindication to orthodontic correction for the varied malocclusions. However, an already challenging oral hygiene regimen will become even more difficult.

Dental Treatment Considerations

Dental treatment considerations for patients with cerebral palsy begin with a preventive approach early in the disease process. These patients can have considerable variation in motor and cognitive skills, which will influence maintenance of optimal oral hygiene. Patients for whom adequate brushing and flossing is a challenge must rely on a caregiver to provide adjunctive or complete oral hygiene care. Demonstrations of the appropriate methods of oral hygiene unique to the patient should be demonstrated to the caregiver in the dental office.

Special care must be used in brushing and flossing for these patients as variability in the control of oromotor function can complicate basic oral hygiene procedures. Expectoration of toothpaste and mouth rinses may be difficult for some patients, and the ingestion of excessive amounts of fluoride is a consideration. Only a small amount of toothpaste should be used and only for one quadrant at a time. If mouth rinses are used as an adjunct for oral care, they should be alcohol free.

The frequency of prophylaxis appointments will be determined by the ability of the patient or caregiver to maintain adequate plaque control. Each appointment should include an examination for caries whose prompt restoration is essential for good long-term oral health. Some patients may have muscle spasms and uncontrolled movements that can compromise the ability to provide dental care. These patients will require sedation and may need treatment at an outpatient hospital center.

Treatment and Prognosis

The treatment and prognosis of cerebral palsy is as variable as the patients afflicted with the disease. There is no cure, but advances in medicine and physical therapy techniques have improved the quality of life for many patients. Professionals must strive to provide adequate access to care, including dental care, for patients with cerebral palsy.

SPINAL CORD INJURIES

In the United States, there are approximately 18,000 new spinal cord injuries each year [45]. The extent of sensory and motor function impairment these patients experience will depend upon the level at which the spinal cord was injured. The more superior the location of the injury, the greater the motor and sensory deficit. Because these injuries are usually the result of sudden, traumatic accidents, the oral health status and needs of the patients will span a considerable spectrum. Patients with higher level spinal cord injuries who are quadriplegic will be dependent upon caregiver assistance for all of their oral health needs. Lower spinal cord injuries causing paraplegia allow patients to use their arms and hands; these patients are often able to maintain oral health independently. As noted, any specific dental considerations for patients with spinal cord injury relate to the level of injuries, the degree of presenting periodontal and carious involvement, and ability to provide adequate long-term maintenance of the teeth and soft tissues.

The patient's physician should be consulted before any dental treatment is begun. Quadriplegic patients may have difficulty with adequate ventilation as well as an impaired gag and cough reflex and problems with the control of oral fluids that can accumulate during dental procedures [46]. Paraplegics usually do not have these difficulties but will require assistance upon transfer from the wheelchair to the dental chair. An accompanying caregiver may assist with the transfer in a manner that will not cause injury to the patient. Dental team members who wish to assist with chair transfers should obtain the proper training.

The sustained pressure on weight-bearing areas common among individuals who use wheelchairs or who are bedridden can cause localized ischemia and the development of decubitus (pressure) ulcers of the skin. If longer appointments are required, a change of the position of the legs can decrease the occurrence of this problem. If they develop, skin ulcerations of this nature can become infected locally and provide a portal of systemic dissemination for pathogenic organisms, potentially resulting in sepsis. Quadriplegic patients may require some of their dental or oral care treatment in a hospital setting.

There is an increased risk of aspirating solids or liquids into the lungs with quadriplegia, and aspiration pneumonia is a possibility [47]. The rapid removal of water from high speed handpieces used for restorative dentistry or during hygiene procedures is mandatory to prevent the aspiration of accumulated fluids. Rubber dam isolation of the area to be treated may not be possible for quadriplegic patients with ventilation issues. Complex treatment for these patients can require a concerted effort of the general dentist and dental specialists. Both quadriplegic and paraplegic patients may have anticoagulants such as warfarin, dipyridamole, or aspirin prescribed to reduce the chance of thrombosis. Procedures in which hemostasis is a concern, including oral surgery, periodontal surgery, and root planing and curettage, should not be undertaken without physician consultation.

Quadriplegic patients who wear dentures or partial dentures will require a caregiver to insert, remove, and clean these prostheses. Some partial dentures can be difficult to insert or remove, so caregivers should receive education regarding appropriate placement and removal techniques. Partial dentures placed or removed with excessive force can traumatize the teeth and oral mucosa and damage the partial denture clasps and framework. Partial and complete dentures must be relined or remade periodically in response to changes of the alveolar bone and overlying oral mucosa. Prostheses that conform to the oral tissues and provide the appropriate occlusion will be an essential component in the oral and overall health of these patients.

Treatment and Prognosis

Today, there is no cure for spinal cord injuries. Those who provide home care for quadriplegic patients must be able to provide adequate oral care on a daily basis. Periodic dental examinations and prophylaxis procedures are also necessary. During dental examinations, the oral health status of patients with spinal cord injuries may be monitored and interventional treatment provided as required.

STROKE

The American Heart Association estimates that every 40 seconds someone in the United States has a stroke [48]. As such, stroke is the fifth leading cause of death in the United States, after heart disease, cancer, accidents, and chronic lower respiratory diseases [49]. Strokes are the result of interruption of the blood supply to the brain via ischemic or hemorrhagic means. Ischemic strokes are more common and develop from the thrombosis of a cerebral vessel or from a distant embolus that has become lodged in a cerebral vessel. Hemorrhagic strokes involve bleeding within the brain; this type of stroke accounts for approximately 10% to 20% of all stroke cases [48,74].

The residual motor and sensory deficits associated with a stroke will depend upon the area of the brain in which the affected cerebral vessel was located. Strokes that involve the patient's dominant side can reduce the neuromuscular coordination that is essential for proper oral hygiene techniques. The hand of the unaffected, non-dominant side can be used in attempt to brush the teeth, and a flosser may be used to floss with only one hand. Physical therapy can help, but not all patients will regain use of the affected side. Stroke patients will depend upon healthcare professionals, while hospitalized, or home caregivers to provide basic oral hygiene procedures. Some stroke patients may require this assistance for the remainder of their lives. Because the oral hygiene of these patients can undergo demise after a stroke, it is essential that periodic dental examinations and prophylaxis appointments be maintained. Oral care should be deferred until the patient is stabilized and elective surgical procedures should be deferred for at least six months after the occurrence of a stroke [9]. The patient's physician should be consulted before any treatment is initiated.

Underlying conditions such as diabetes, hypertension, and cardiovascular disease may have been instrumental in causing the stroke. Medications prescribed for these and other chronic conditions may affect the selection of local anesthetics, analgesics, and antibiotics that are used for dental treatment. In addition, anticoagulant medications such as warfarin, clopidogrel, or aspirin are usually prescribed to decrease the chance of another stroke. Anticoagulants' intended effects can be potentiated with the coadministration of many medications used in dentistry, including NSAIDs (e.g., ibuprofen, naproxen), penicillin, and amoxicillin [50]. Patients on anticoagulant therapy should not have any invasive procedure without collaboration with their physician. A temporary hold on anticoagulants may be necessary unless the risk of another stroke or other cardiovascular event precludes the temporary discontinuance. Patients should never discontinue anticoagulant therapy unless it is under the guidance of a physician. If use of anticoagulants must be continued, laboratory values such as INR and PT can provide the clinician with necessary information regarding the patient's ability to achieve hemostasis. Further considerations for patients on anticoagulant therapy will be discussed later in this course.

Dental Treatment Considerations

Dental treatment considerations vary considerably among stroke survivors according to the initial amount of cerebral damage and the level of long-term disability. Even patients for whom minimal damage has occurred and who appear to have minimal motor and sensory deficits should not undergo dental treatment until physician approval has been granted. Unfortunately, many stroke victims do retain long-term or permanent sensory, motor, and cognitive problems that impact oral health and function and the ability to undergo dental treatment.

Dysphagia can occur when strokes cause neural and muscular compromise to the floor of the mouth, the tongue, and the pharynx. Eating and drinking can become a challenge with this condition, and patients may select foods of softer consistency that facilitate swallowing but compromise proper nutrition. The same neural and muscular issues can make partial dentures difficult to wear and the use of complete dentures nearly impossible. Partial dentures are retained by teeth and only partially reliant upon a balance of muscular forces for their retention. A complete maxillary (upper) denture depends upon a functioning musculature, especially at the junction of the hard and soft palates, for its retention. A complete mandibular (lower) denture relies on a balance between the muscles of the cheeks, tongue, chin, and floor of the mouth for retention. When stroke-related involvement of one or more of these muscles occurs, the stability and retention of prostheses are compromised. Patients may also feel that it is difficult to re-establish the proper occlusal pattern needed for proper mastication. The use of implant-retained dentures or denture adhesives (zinc-free) may be of assistance. However, surgery for implant placement should only be done with physician approval.

Cognitive impairment may remain for the patient's lifetime. Matters related to treatment options and informed consent may be beyond the comprehension of some post-stroke patients and will be delegated to their legally appointed representative.

Because many stroke patients are also being treated for hypertension, the use of vasoconstrictors, such as epinephrine and levonordefrin, which are combined with most local anesthetics, should be kept to an absolute minimum or avoided. Appointments should be kept short and as stress-free as possible, with vital signs monitored throughout. Patients should be kept in a position that accommodates unilateral weakness or paralysis and protects them from the accumulation of fluids and debris in the mouth. Many stroke patients develop dysarthria, a condition in which the muscles used for proper speaking are weakened, resulting in slurred speech. Clinicians will need to spend more time to communicate effectively with patients when this occurs.

Approximately 30% of stroke survivors have depression [51,71]. This can decrease patients' desire for recovery and can result in an overall decline in oral hygiene. Some antidepressants used in the treatment of depression can cause xerostomia. As discussed, xerostomia decreases the cleansing action of saliva and increases the retention of plaque on teeth and within the gingival sulcus, resulting in an increased risk of caries and periodontal problems. Tricyclic antidepressants such as amitriptyline can potentiate the vasopressor effects of both epinephrine and levonordefrin [51]. The concurrent use of these agents can raise the blood pressure to levels that endanger stroke survivors, and their use should be avoided.

Treatment and Prognosis

Treatment and prognosis vary among stroke survivors. The underlying medical condition(s) that precipitated the stroke require continuing treatment to decrease the risk of recurrence of stroke. Patients should be evaluated on an individual basis to determine their ability to maintain adequate oral hygiene and optimal oral health. Careful attention to the medical issues that confront stroke patients will allow necessary dental treatment to be accomplished in a safe manner.

Considerations for Patients on Anticoagulant Therapy

Many stroke patients are initiated on anticoagulant therapy as a secondary prevention measure. Anticoagulant medications influence the synthesis of clotting factors. Antiplatelet therapy is used to decrease the risk of adverse cardiovascular events in patients with arterial or venous thrombosis, ischemic heart disease, coronary artery stents, or a history of an ischemic cerebrovascular accident [52]. Aspirin and clopidogrel, used individually or in combination, are among the most common of these agents. Aspirin inhibits the formation of thromboxane A2, a platelet product necessary for platelet adhesion. This inhibitory effect lasts for the 7- to 10-day lifespan of the platelet; the production of new platelets overcomes the inhibitory effects [53]. Clopidogrel inhibits the activation of platelets and ultimately the fibrinogen binding that is required for platelet adhesion.

Among the coumarin derivative class of anticoagulant medications, warfarin is the most commonly prescribed. Warfarin inhibits the synthesis of Factors VII, IX, and X and prothrombin, all of which are vitamin K-dependent coagulation proteins. The efficacy of warfarin therapy is monitored using the INR, the values of which reflect the therapeutic range of anticoagulant therapy. This ratio is determined by dividing the PT of the patient by the mean normal PT of the laboratory. The latter is determined by using the International Sensitivity Index [54]. A value of 1.0 reflects normal PT, while higher values indicate an extended PT. The goals of anticoagulant therapy are determined by the nature and extent of the medical problem involved. Prescribed and over-the-counter medications used in the treatment of oral conditions must not potentiate the intended therapeutic range of anticoagulant therapy, as internal bleeding can result. When procedures such as periodontal surgery or root planing and curettage are planned, verifying the patient's ability to attain and maintain hemostasis is essential. When extensive treatment such as multiple or full-mouth extractions is planned, postoperative bleeding can be significant and the procedure may need to be performed in a hospital setting. Patients who use either clopidogrel or aspirin for antiplatelet therapy have a lower risk of postoperative bleeding compared to those on combination therapy. As discussed, patients must be advised never to discontinue their anticoagulant or antiplatelet therapy unless it is approved by their physician.

NSAIDs, some antibiotics, and certain antifungal medications can increase the risk of postoperative bleeding when they are combined with anticoagulant or antiplatelet medications. Whenever possible, alternative medications should be utilized. The duration of anticoagulant and antiplatelet therapy is usually for the lifetime of the patient. Dental clinicians must be cognizant of the patient's current regimen and note any difficulties in internal or occult bleeding that would indicate potential problems in the achievement of postoperative hemostasis. Recent INR value and PT and consultation with the patient's physician can provide guidance for the course of dental treatment that is the safest for the patient.

5. CONDITIONS CAUSING COGNITIVE IMPAIRMENT

DOWN SYNDROME

Down syndrome is a genetic disorder resulting from an aberration of the 21st autosomal chromosome. Nearly 95% of those affected have a complete extra chromosome (trisomy 21) while the remaining 5% have other chromosomal abnormalities, including mosaic trisomy 21 [55,56]. In the United States, more than 400,000 individuals are living with Down syndrome [56]. The development of mental and physical features progresses more slowly for individuals with Down syndrome compared with those without it. The development of motor and language skills is delayed, and the degree to which they are ultimately impaired varies considerably among these individuals, as does intellectual capacity. Most patients with Down syndrome have some degree of intellectual disability that will challenge their cognitive development. Common anomalies and trends in the oral and maxillofacial region can challenge the ability of patients with Down syndrome to maintain optimal oral health.

The presence of an underdeveloped maxillary arch is typical among patients with Down syndrome. This coupled with a mandibular arch of normal dimensions establishes a Class III jaw relationship (mandibular prognathism or underbite) [57]. Abnormal morphology of the teeth, such as shorter and smaller clinical crowns, coupled with a Class III malocclusion can cause compromised occlusal function and difficulties with the proper mastication of food. The delayed eruption sequence of teeth and a higher incidence of congenitally missing teeth among these patients can further prevent the development of a stable occlusion [58]. The occurrence and severity of periodontal disease are both more prevalent among individuals with Down syndrome. The aforementioned problems with congenitally missing or late erupting teeth can cause teeth to drift and incline in a fashion that does not facilitate optimal oral hygiene. Deficiencies in the immune system among these individuals will diminish the response against pathogenic bacteria. Leukocytes such as granulocytes and lymphocytes are the primary cells involved with defense against bacterial infections [59,60]. Nearly half of patients with Down syndrome have chemotactic defects in their neutrophils that prevent the proper migration of these leukocytes towards the pathogenic bacteria [61]. The function of T-lymphocytes is also compromised among many patients with Down syndrome. A combination of decreases in both mitotic activity and the response to an antigenic challenge and an increase in the production of immature T-lymphocytes diminishes the appropriate immune response to periodontal pathogens [62].

When loss of alveolar bone results from this combination of factors, patients with Down syndrome are at a greater risk of tooth loss due to root anatomy variances. Shorter roots and the fusion of molar roots that are usually separate and divergent mean these teeth have less attached alveolar bone at the onset [63]. Therefore, bone loss that would not threaten the retention of teeth in patients without Down syndrome may cause advanced mobility and a poor prognosis for retention among this patient population. The ability for patients with Down syndrome to brush and floss properly will be commensurate with the degree to which their motor skills and cognitive ability have developed. Given these circumstances it is imperative that oral home care and recall appointments combine to create as healthy an oral environment as possible. It may be necessary for caretakers to assist in basic hygiene techniques.

The prevalence of dental caries varies among patients with Down syndrome. The delayed eruption of both the deciduous and permanent dentition common among patients with this disorder decreases the time of exposure to cariogenic bacteria. Clinical crowns that are smaller than average can create spaces between the teeth and can actually facilitate their cleansing. Smaller nasal passages and increased tonsillar volume can cause congestion of the upper respiratory tract. Open-mouthed breathing is a compensatory mechanism for this problem [64]. This breathing pattern has a drying effect on dental plaque and can increase the incidence of both dental caries and periodontal disease. If this pattern is noted, increased frequency of brushing and flossing combined with shorter intervals between dental recall appointments must be enacted.

Treatment and Prognosis

Medical advances have increased the life expectancy of patients with Down syndrome. While these patients have a higher tendency for diverse medical problems, including cardiac issues and seizure disorders, many live past 55 years of age and some outlive their parents. Arrangements for a succeeding caretaker may involve another family member, or in some cases, institutionalization. In either case, access to dental care should remain a steadfast commitment. Most patients with Down syndrome can be treated by a general dentist in a traditional office setting. Patients with moderate-to-severe intellectual disability may require sedation in office or at an outpatient hospital setting. Consistent recall appointments and evaluation of the patient's daily oral hygiene regimen are both proactive practices that can positively impact oral health and quality of life.

ALZHEIMER DISEASE

Approximately 6.9 million people in the United States are living with Alzheimer disease, a major cause of dementia [65]. Alzheimer-type dementia occurs in 10.9% of Americans older than 65, and as many as 33.4% of patients 85 years of age or older [66]. Alzheimer disease is the most common form of dementia and is responsible for 60% to 80% of all new dementia cases [67]. It is a slowly progressing disease that causes memory loss, cognitive impairment, changes in personality, and ultimately, functional impairment and inability to carry out activities of daily living. The initial stage features minimal cognitive impairment and memory loss. Progression to the middle stage features language impairment and the loss of abstract reasoning skills. These problems along with delusions, paranoia, and marked personality changes are seen in the late stage of the disease. Patients in the end-stage of Alzheimer disease become rigid, incontinent, and bedridden. These patients usually succumb to cardiac problems, pulmonary embolisms, or opportunistic infections (e.g., aspiration pneumonia) [68].

Dental Treatment Considerations

There are no oral lesions that are unique to Alzheimer disease. The dental considerations for these patients involve proactive and preventive care in the early stages of the disease while patients are most cooperative and are able to provide a reasonable level of basic oral hygiene by themselves. The ability of the patient to cooperate during dental treatment will decrease during the later stages of this disease. Thus, addressing dental problems as soon as possible after a diagnosis of Alzheimer disease has been confirmed as essential.

The interaction of medications prescribed for Alzheimer disease and systemic illnesses with those utilized for dental treatment are an additional concern. Patients with Alzheimer disease for whom periodontal problems have been controlled and carious lesions have been restored will require recall appointments, the frequency of which is determined by the patient's or caregiver's ability to maintain adequate home care. As this disease progresses, patients may forget to brush and floss their teeth on a regular basis (or forget what a toothbrush is) and may not be cooperative when a caregiver attempts to provide this service. This can potentiate existing periodontal problems or cause new problems to develop. Similarly, new and recurrent carious lesions can develop when the ability to maintain oral hygiene declines.

Because cognitive ability can vary considerably among patients with Alzheimer disease, even in the initial stages, it may be necessary to obtain consent for treatment from an accompanying caregiver or family member. Some patients with Alzheimer disease will not seek routine dental care, and advanced periodontal problems and multiple carious lesions can develop. An attempt to resolve these periodontal issues and to restore the carious lesions is the ideal treatment plan. However, maintenance of these teeth will become more difficult as the disease progresses. The patient, caregiver, and allied healthcare team must discuss optimal treatment options. Patients who did not practice good oral care prior to the diagnosis of Alzheimer disease are unlikely to improve these skills. Extractions of periodontally involved teeth and those with extensive carious lesions can be a practical option for these patients. As the patient's ability to cooperate during dental treatments declines, procedures that require longer appointments and are more complex must be done as early in the disease progression as possible. If partial or complete dentures are made, the patient's name should be incorporated into the acrylic of each prosthesis. This identifying feature will facilitate the return to the appropriate patient if the prosthesis is misplaced. Partial dentures should have a simplified design to facilitate their insertion and removal, and caregivers should be taught these techniques and appropriate home care.

Treatment and Prognosis

Depletion of the cerebral neurotransmitter acetylcholine is a contributing factor in the development of Alzheimer disease, and medications such as donepezil, rivastigmine, galantamine, and memantine are used to reduce the degradation of acetylcholine by the enzyme acetyl cholinesterase [69]. These medications can stimulate the secretion of gastric acid and increase the risk of the development of peptic ulcers [9]. Concurrent use with NSAIDs can increase this risk, so alternative medications compatible with the patient's medical history should be utilized.

Antidepressant and psychotropic medications may also be prescribed for patients with Alzheimer disease. Narcotic analgesics and sedatives can potentiate the effects of these medications and may need to be avoided. Medications for concurrent chronic disease(s) can also influence the selection of analgesics, antibiotics, local anesthetics, and sedatives used for dental problems and treatment. A consultation with the patient's physician should be completed prior to the initiation of dental treatment and updated as the disease progresses. The late and end stages of the disease may require that necessary dental care is performed via sedation or under general anesthesia in a hospital setting. Maintaining the oral comfort and dignity of the patient should be the primary goal of dental treatment.

6. CONCLUSION

This course has highlighted a diverse group of acquired and congenital diseases and syndromes that can significantly impact the lives of patients. All diseases and syndromes discussed are incurable and will impact the patient's and/or caretaker's ability to maintain optimal oral hygiene and the clinician's ability to provide dental treatment. Similarly, medications used to treat these conditions may interact with medications involved in dental or oral care; the use of alternative medications may be necessary. Although each of the diseases/conditions has been discussed singularly, many patients have concurrent illnesses that synergistically complicate their oral and overall health. Furthermore, the aging process can increase the morbidity associated with these diseases.

Dental treatment should be an integral part of the overall health care of any patient with disability. Early preventive treatment can minimize the potential for the development of carious lesions and periodontal problems. Frequent recall appointments reflecting each patient's ability to maintain ideal oral hygiene will also serve to identify new carious lesions and emerging periodontal problems. When these issues are discovered in their initial phases, treatment is less complicated and less expensive compared to treatment attempted when the issues are advanced. Patients with cognitive impairment and neuromuscular degeneration may have difficulty withstanding longer appointments that are required for complex dental treatment. Thus, early identification of dental problems and a proactive approach for their treatment is in the best interest of all. Meticulous attention to the details of a patient's medical problem(s) and prescribed medications allows oral home care and dental treatment to be performed in a unified approach that promotes ideal oral health as a part of an optimum quality of life.

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Evidence-Based Practice Recommendations Citations

1. Sjögren's Foundation. Oral Management: Caries Prevention in Sjögren's Patients. Available at https://www.sjogrens.org/sites/default/files/inline-files/SF_PCG-Oral_0.pdf. Last accessed April 25, 2025.

2. Panel on Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV. Available at https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-oi/guidelines-adult-adolescent-oi.pdf. Last accessed April 25, 2025.

3. National Institute for Health and Care Excellence. Parkinson's Disease in Adults. Available at https://www.nice.org.uk/guidance/ng71. Last accessed April 25, 2025.

54680 • Caries-Prone Patients: Prevention, Assessment, and Intervention

Mark J. Szarejko, DDS, FAGD

www.netce.com

Copyright © 2024 NetCE, All rights reserved.

The impact of nutrition on the caries process is known in the dental field, but dental professionals need to continue to convey the importance of this relationship to patients. Working as partners with patients, dental professionals can aid in the prevention of dental caries and help maintain patients' overall health by offering nutritional counseling and behavior modification techniques. The incidence of caries in the United States could decrease significantly as dental professionals implement the advances available for early caries detection, recommend anticaries treatments, and offer nutritional analysis and counseling.

Table of Contents

54680 • Caries-Prone Patients: Prevention, Assessment, and Intervention

Course Overview

Audience

Accreditations & Approvals

Designations of Credit

Course Objective

Learning Objectives

Faculty

Faculty Disclosure

Director of Development and Academic Affairs

Director Disclosure Statement

About the Sponsor

Disclosure Statement

Implicit Bias in Health Care

1. INTRODUCTION

2. THE CARIES PROCESS

MICRO-ORGANISMS AND DENTAL PLAQUE

SUSCEPTIBLE TOOTH SURFACE

DIET

TIME/FREQUENCY

3. CARIES LESION DETECTION METHODS

4. ORAL CARE HABITS

AMERICAN DENTAL ASSOCIATION RECOMMENDATIONS

ORAL HYGIENE INSTRUCTION

5. CARIOUS DIETS

SNACKING

FAST FOOD

SODA/SOFT DRINKS

FACTORS INFLUENCING DIET

6. POPULATIONS AT RISK

CHILDREN

ADOLESCENTS

OLDER ADULTS

PATIENTS WITH XEROSTOMIA

7. CARIES PREVENTION PRODUCTS AND PROCEDURES

FLUORIDE

XYLITOL

SEALANTS

8. CARIES RISK ASSESSMENT

9. NUTRITIONAL COUNSELING

THE NUTRITIONAL COUNSELING APPOINTMENT

SETTING GOALS

10. CASE SCENARIOS

CASE SCENARIO 1: SAVANNAH'S FIRST DENTAL APPOINTMENT

CASE SCENARIO 2: HE'S GOT ALL THE ANSWERS

11. CONCLUSION

12. RESOURCES

Works Cited

54680 • Caries-Prone Patients: Prevention, Assessment, and Intervention

Education Category. Infection Control / Internal Medicine

Release Date. 07/01/2024

Expiration Date. 06/30/2027

Course Overview

The impact of nutrition on the caries process is known in the dental field, but dental professionals need to continue to convey the importance of this relationship to patients. Working as partners with patients, dental professionals can aid in the prevention of dental caries and help maintain patients' overall health by offering nutritional counseling and behavior modification techniques. The incidence of caries in the United States could decrease significantly as dental professionals implement the advances available for early caries detection, recommend anticaries treatments, and offer nutritional analysis and counseling.

Audience

This course is designed for dental professionals involved in the prevention and treatment of caries.

Accreditations & Approvals

NetCE Nationally Approved PACE Program Provider for FAGD/MAGD credit. Approval does not imply acceptance by any regulatory authority or AGD endorsement. 10/1/2021 to 9/30/2027 Provider ID #217994. NetCE is an ADA CERP Recognized Provider. ADA CERP is a service of the American Dental Association to assist dental professionals in identifying quality providers of continuing dental education. ADA CERP does not approve or endorse individual courses or instructors, nor does it imply acceptance of credit hours by boards of dentistry. Concerns or complaints about a CE provider may be directed to the provider or to ADA CERP at www.ada.org/cerp. NetCE is approved as a provider of continuing education by the Florida Board of Dentistry, Provider #50-2405. NetCE is a Registered Provider with the Dental Board of California. Provider Number RP3841. Completion of this course does not constitute authorization for the attendee to perform any services that he or she is not legally authorized to perform based on his or her license or permit type.

Designations of Credit

NetCE designates this activity for 4 continuing education credits. AGD Subject Code 250. This course meets the Dental Board of California's requirements for 4 unit(s) of continuing education. Dental Board of California course #04-3841-26425.

Course Objective

The purpose of this course is to equip all members of the dental team with the skills needed to implement the advances available for early caries detection, recommend anticaries treatments, and offer nutritional analysis and counseling.

Learning Objectives

Upon completion of this course, you should be able to:

1. Describe the caries process and methods for its detection.

2. List the oral care habits recommended by the American Dental Association.

3. Identify the dietary choices of patients and the factors that influence the diets of patients.

4. Recognize populations at increased risk for caries and describe caries prevention products and procedures for this population.

5. Explain the use of personalized patient care and nutritional counseling to decrease incidence of caries.

Faculty

Mark J. Szarejko, DDS, FAGD, received his dental degree from the State University of New York at Buffalo in 1985. He received fellowship from the Academy of General Dentistry in 1994.

Faculty Disclosure

Contributing faculty, Mark J. Szarejko, DDS, FAGD, has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Director of Development and Academic Affairs

Sarah Campbell

Director Disclosure Statement

The Director of Development and Academic Affairs has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

About the Sponsor

The purpose of NetCE is to provide challenging curricula to assist healthcare professionals to raise their levels of expertise while fulfilling their continuing education requirements, thereby improving the quality of healthcare.

Our contributing faculty members have taken care to ensure that the information and recommendations are accurate and compatible with the standards generally accepted at the time of publication. The publisher disclaims any liability, loss or damage incurred as a consequence, directly or indirectly, of the use and application of any of the contents. Participants are cautioned about the potential risk of using limited knowledge when integrating new techniques into practice.

Disclosure Statement

It is the policy of NetCE not to accept commercial support. Furthermore, commercial interests are prohibited from distributing or providing access to this activity to learners.

Implicit Bias in Health Care

The role of implicit biases on healthcare outcomes has become a concern, as there is some evidence that implicit biases contribute to health disparities, professionals' attitudes toward and interactions with patients, quality of care, diagnoses, and treatment decisions. This may produce differences in help-seeking, diagnoses, and ultimately treatments and interventions. Implicit biases may also unwittingly produce professional behaviors, attitudes, and interactions that reduce patients' trust and comfort with their provider, leading to earlier termination of visits and/or reduced adherence and follow-up. Disadvantaged groups are marginalized in the healthcare system and vulnerable on multiple levels; health professionals' implicit biases can further exacerbate these existing disadvantages.

Interventions or strategies designed to reduce implicit bias may be categorized as change-based or control-based. Change-based interventions focus on reducing or changing cognitive associations underlying implicit biases. These interventions might include challenging stereotypes. Conversely, control-based interventions involve reducing the effects of the implicit bias on the individual's behaviors. These strategies include increasing awareness of biased thoughts and responses. The two types of interventions are not mutually exclusive and may be used synergistically.

1. INTRODUCTION

Dental caries is a preventable disease that affects a majority of the population. According to the 2011–2016 National Health and Nutritional Examination Survey, approximately 90% of adults 20 to 64 years of age had at least one decayed tooth [1]. Data collected between 2017 and 2020 indicate that among children and adolescents 2 to 19 years of age, 46.0% had one or more carious lesions in their primary or permanent teeth [2]. These statistics show the increase in caries incidence over time, making it important for dental professionals to develop strategies for determining caries risk and counseling patients to reduce risk and a future of dental caries.

The impact of nutrition on the caries process is known in the dental field, but dental professionals need to continue to convey the importance of this relationship to patients. Working as partners with patients, dental professionals can aid in the prevention of dental caries and help maintain patients' overall health by offering nutritional counseling and behavior modification techniques. The incidence of caries in the United States could decrease significantly as dental professionals implement the advances available for early caries detection, recommend anticaries treatments, and offer nutritional analysis and counseling. This basic-level course is intended to equip all members of the dental team with the skills needed to realize this over-riding goal.

2. THE CARIES PROCESS

Dental caries is a multifactorial disease. It is also preventable. In order for caries disease to occur, a number of factors must be present, including caries-causing microorganisms, a susceptible tooth surface, fermentable carbohydrates, and time. Dental professionals have the obligation to inform adult patients and parents of young patients that they possess the power to prevent and reverse this disease process. In this section, the factors that affect caries development will be addressed.

MICRO-ORGANISMS AND DENTAL PLAQUE

Untreated dental caries among deciduous ("baby/milk") teeth is the most prevalent childhood ailment, affecting 514 million children globally. Overall, dental caries affects 97% of the global population at some point in their lives [3,4]. The accepted theory of caries formation is related to the acids produced by oral bacteria removing tooth surface minerals, eventually causing a cavitation. Streptococcus mutans (S. mutans), S. sobrinus, Bifidobacterium species, and Lactobacillus micro-organisms have all been found to aid in caries progression [5,6]. These same bacteria are associated with root caries, as are the micro-organisms Actinomyces viscosus and A. naeslundii, which are notably present in active lesions [7].

Infants are not born with pathogenic oral bacteria but can acquire them from the skin or vaginal area during delivery or from family members with whom they are in close contact [8]. It has been determined that these bacteria can be transmitted between individuals through kissing, sharing eating utensils or cups, and other interactions. Studies have demonstrated that the mouth of the neonate is colonized by bacteria that resemble those from the oral cavity of the mother [9]. Women of childbearing age, parents, and caregivers of young children should be educated about the potential to transmit the bacteria contributing to dental caries.

SUSCEPTIBLE TOOTH SURFACE

All erupted teeth have the potential to develop caries lesions. However, teeth with optimal fluoride content are more resistant to caries lesion development than are teeth lacking in fluoride, as fluoride has an essential role in protecting enamel from demineralization [10]. Patients with recession (exposed root surfaces) are at increased risk for dental caries because roots do not have enamel, the extremely hard and most caries-resistant material surrounding the crown of the tooth.

DIET

A diet high in sugar, including fermentable carbohydrates, increases the likelihood of developing dental caries. Included are foods that are innately sugary (e.g., juices), those with sugar added (e.g., soda and candy), and starchy foods that break down into sugars in the mouth (e.g., breads and crackers).

When fermentable carbohydrates are introduced into the mouth, the sugars begin to be broken down to acid by oral bacteria. This acid lowers the pH of the saliva and oral plaque biofilm and may increase the rate of demineralization of tooth surfaces. Tooth enamel begins to demineralize at a pH of 5.5, and root surface demineralization occurs at an even milder pH of 6.2 [11]. Once the pH dips into these ranges, the outer layer of the tooth loses minerals. This causes a loss in surface hardness and increases the possibility of caries lesion progression.

TIME/FREQUENCY

Time is a contributing factor in the caries process because the probability of caries increases as the frequency of acid formation from fermentable carbohydrate–rich food sources increases [6]. Simply stated, the more often fermentable carbohydrates are ingested, the more often salivary pH will decrease, and the greater the likelihood that teeth will experience demineralization. The extent of demineralization depends on the length of time the acidic biofilm is in contact with the tooth surface and the frequency of this contact. Caries lesions are the result of repeated or extended periods of demineralization.

3. CARIES LESION DETECTION METHODS

Caries lesions are detected a number of ways [3,12,13,14]:

- Visual examination is employed for diagnosing large pit and fissure, root surface, and facial and lingual smooth surface caries lesions.

- Inspection with a blunt explorer or probe over the surfaces of teeth is the tactile method of detecting caries lesions. This exploration is especially effective around margins of existing restorations.

- Using the air/water syringe to visualize teeth wet and dry is helpful. Demineralized surfaces will look dull, chalky, and irregular when dry.

- Radiographs can be used to identify interproximal caries before they can be detected visually or tactilely, allowing for diagnosis when they are small or incipient.

- Transillumination is the technique of shining light through the teeth with a dental light and mirror or with fiber-optic equipment. Various lasers for caries detection are available from dental equipment manufacturers. These methods allow tooth examination without risking cavitation of decalcified tooth surfaces, as may occur with the use of dental instruments.

Employing a combination of these methods increases the probability of finding carious lesions in early stages when restorative treatment can be minimal or may even be avoided. A thorough dental examination helps the dental professional to determine a patient's caries risk level because any caries activity, including the presence of white spots or demineralization, automatically places a patient at high risk for caries development [15].

4. ORAL CARE HABITS

The role of plaque biofilm in the caries process necessitates the teaching and frequent reviewing of proper oral hygiene with patients. It is possible to distinguish patients who are at increased risk for dental caries by recognizing patients with poor oral care habits.

AMERICAN DENTAL ASSOCIATION RECOMMENDATIONS

To prevent tooth decay, the American Dental Association recommends the following oral hygiene behaviors [16]:

- Brush teeth twice a day.

- Brush for two to three minutes.

- Use a fluoride toothpaste that is ADA-accepted.

- Replace the toothbrush every three to four months, or more frequently if bristles are fraying.

- Floss or use an interdental cleaner daily to remove bacteria between teeth and under the gum line.

- Limit snacking and eat a balanced diet.

- Develop a customized at-home oral hygiene regimen that includes the use of prescription-strength fluoride gels or toothpastes.

- Establish a dental recall schedule that reflects the patient's ability to maintain ideal oral hygiene.

ORAL HYGIENE INSTRUCTION

Since the average patient brushes for less than one minute and few adults floss daily, it is important to review the ADA guidelines with patients at dental visits. To increase patient acceptance and understanding of oral hygiene instructions, it is advantageous for the dental professional to give patients the opportunity to demonstrate oral hygiene techniques. This allows the patient to receive feedback and gain confidence.

Power toothbrushes may be advisable for some patients because they are better than manual toothbrushes at reducing dental plaque levels and can be an exceptional oral hygiene tool for orthodontic patients and those with limited manual dexterity [16]. Timers may also be recommended to ensure that patients are brushing for a full two to three minutes.

5. CARIOUS DIETS

In order to decrease caries through nutritional counseling, the dental professional must understand the most common caries-promoting behaviors and diet choices among the population. Poor nutrition can promote the development of carious lesions and can also have an adverse effect upon the structural integrity of the gingival tissues, the oral mucosa, and the periodontium [17].

SNACKING

Snacking is a common habit in the United States, with 90% of U.S. adults reporting one or more snacks per day—which accounts for approximately 22% of their daily energy intake [18]. Snacking promotes caries for a number of reasons. First, patients do not often brush or floss after eating snacks, leaving food debris and dental plaque biofilm in the mouth for extended periods. Second, most snack foods either have elevated sugar content or—like potato chips and crackers—are high in fermentable carbohydrates, allowing for acid formation from oral bacteria. Third, snacks are usually eaten throughout the day, permitting oral bacteria to produce acid and lower the salivary and plaque biofilm pH multiple times in a relatively short period.

Snacking habits have changed over the years, making it important for dental professionals to stay abreast of healthy options and nutritional evaluation techniques. Over a span of 35 years—between 1977 and 2012—there was a significant increase in per capita energy intake from snacking. The snack foods and beverages consumed were typically sugar-sweetened beverages, desserts, sweets, and salty snacks, the consistent consumption of which is not ideal for oral or systemic health [18]. The consumption of such snacks between meals or at a time that is typically not conducive to tooth brushing leads to a cumulative effect of an increased potential for the development of carious lesions. It is estimated that in the United States, approximately 22% of the daily caloric intake is from snacks that are sweet, salty, or desserts despite dietary guidelines that these items should comprise a limited portion of the daily caloric intake [18]. Even patients trying to eat healthfully may fall prey to ingesting excessive sugar because many snack foods marketed as "low-fat" have increased sugar per serving to improve taste once the fat is removed.

The average American consumes approximately 20 teaspoons of sugar every day via ingredients in foods and beverages such as fructose, dextrose, and high-fructose corn syrup [19]. The amount of sugar in the typical American diet not only promotes caries but also underlies the increase in obesity, heart disease, and diabetes in the general population. The American Heart Association recommends that men consume no more than 9 teaspoons (36 grams or 150 calories) of added sugar per day and that women consume no more than 6 teaspoons (25 grams or 100 calories per day) of added sugar per day [20].

The Nutritional Questionnaire and Food Log shown in Table 1 is an example of a dietary questionnaire that clinicians can use to gather nutritional information that is pertinent to oral health. A food log can help the dental professional guide patients to modify snacking habits and include fewer fermentable carbohydrates and sugars. Some dental providers ask their patients each question, and the questions can be customized depending on previous knowledge. Other dental providers send questionnaires home with patients and assess them at a subsequent appointment.

Table 1: NUTRITIONAL QUESTIONNAIRE AND FOOD LOG

Source: Author

The technique used would depend on the caries risk of the individual and the suspicion that diet plays a role. See the Resources section for websites that contain valuable information and interactive programs to help patients improve their diets.

To decrease caries risk, dental professionals should encourage patients to make changes in the composition and frequency of snacks—moving toward more healthy choices. Even minor changes, such as limiting snacks to a period of 10 to 15 minutes once a day and brushing teeth or chewing sugar-free gum after snacks, may decrease this common habit's negative effects on patients' teeth.

FAST FOOD

The American population's consumption of fast food has been growing steadily for many years. Data from the National Health and Nutrition Examination Survey of 2017–2018 indicated that on an average day, 36.5% of American adults consume fast food, which accounted for 13.8% of their daily calories [21]. Children and adolescents vary in their daily caloric intake from fast food consumption. Each day, approximately 36.3% of children and adolescents consume fast food, with 11.4% of children and adolescents obtaining more than 45% of their daily caloric intake from fast food; 13.8% obtaining 25% to 40% of their caloric intake from fast food; and 11.1% obtaining less than 25% of their caloric intake from fast food [22]. Clearly, millions of Americans consume fast food on a regular basis, and this is associated with a high caloric intake and poor diet quality. Patients who eat fast food meals or snacks laden with carbohydrates are at increased risk for caries due to the high amounts of sugar and fermentable carbohydrates present in fast food items [23]. Being armed with knowledge of the statistical relationships between fast food and caries may help the dental professional counsel patients on making healthier fast food choices.

In addition, there is a correlation between eating fast food on a regular basis and developing insulin resistance, which is a risk factor for type 2 diabetes [24]. To guide patients with diabetes and the general public toward healthier fast food options, the practitioner can refer patients to the American Diabetes Association website (http://www.diabetes.org), their physician, or a nutritionist for guidance specific to the patient's health condition, keeping in mind that as a dental professional, oral health should remain a focus.

SODA/SOFT DRINKS

Within the United States, the median annual per capita consumption of sugar-sweetened beverages (SSB) in 2021 was 37.1 gallons, with the annual per capita consumption of SSB the lowest in Hawaii (23.5 gallons) and the highest in Missouri (51.8 gallons) [25]. Most people are unaware of the sugar content of their favorite sugar-sweetened beverage or soda, and they are not aware of the daily recommended maximum amount of sugar. The World Health Organization has recommended that for children the maximum daily consumption of sugar is 3 teaspoons. A 20-ounce bottle of soda contains about 16 teaspoons of sugar, while a 12-ounce can contains about 10 teaspoons of sugar [26]. Many nutritional experts and health organizations believe that soda and SSB in general are a major contributing factor to the escalation of childhood and adult obesity [27]. The consumption of soda doubles the risk of the development of carious lesions in children and increases the potential for the development of carious lesions in adults [26].

The patient education pamphlet "Sip All Day, Get Decay!" produced by the Minnesota Dental Association (available at http://www.sipallday.org) states that the average 12-ounce can of soda has 10 teaspoons of sugar and a pH just over 3. The low pH of soft drinks results from the ingredient phosphoric acid. Sodas also contain carbonic acid, and many contain citric acid. Therefore, even diet sodas are detrimental to oral health due to their acidic pH levels.

Patients who sip soda throughout the day cause their oral pH to plunge due to the acidity of the soda and the acid formed from oral bacteria metabolizing the sugars with this extended exposure a source of an increased risk for the development of dental caries [28].

Sports drinks and fruit juices also tend to be acidic and contain high amounts of sugar [29,30]. The use of these products should be limited. Milk and water remain the best drink options for healthy teeth. The development of flavored, unsweetened water gives patients another drink option that is not detrimental to their teeth.

FACTORS INFLUENCING DIET

It is important for dental professionals to study the factors influencing patients' diet choices to understand the motivations behind them and to offer healthy alternatives. Factors influencing diet include food availability, family structure, convenience, parental influence, habit, cost, and media [31,32].

Food Availability and Convenience

As the number of Americans who are eating meals prepared outside of the home continues to increase, food availability and convenience have become factors that greatly influence food choices. The majority of foods that are considered "convenient" are high in sugar, refined or fermentable carbohydrates, and fat [17,18]. These foods are therefore unhealthy choices for oral and systemic health. Examples of convenience foods include hamburgers, chips, vending machine snacks, and candy bars.

The prevalence of vending machines gives people access to many low-nutrient, energy-dense snacks on a daily basis [33,34]. The Smart Snacks school nutrition standards became effective at the beginning of the 2014–2015 school year and established limits on the amount of fat, sugar, sodium, and calories in foods that are sold in vending machines within school settings [35]. The Smart Snacks school nutrition standards have specific nutritional requirements for food items sold in vending machines, student stores, and snack bars [36]. However, simply not having these options available is not the complete answer. Hungry teens need to understand the benefits of high-nutrient snack options and learn to seek them out.

Within the United States, vending machines are present in 43% of elementary schools, 74% of middle schools, and 98% of high schools [37]. Though Congress has mandated a reduction of foods and snacks in schools that are correlated with obesity and dental caries, schools continue to struggle with replacing these items with more nutritional, low-fat options as do hospitals and workplaces [38]. Many schools gain some revenue from vending machine sales, which adds to the complexity of changing food items. Schools, food vendors, and families continue to struggle with balancing nutrition, funding, and adolescents' food preferences. Vending machines are found in many places besides schools, and the low nutritional quality of vending machine foods is generally consistent throughout the different locations [38]. Increasing the nutritional value of foods available through vending machines would have a positive impact on various groups. Dental professionals should educate patients about the healthiest and least caries-promoting vended items, such as sunflower seeds, nuts, crackers with cheese, and sugar-free gum.

Many fast food chains have added more nutritious options to their menus in an effort to appeal to health-conscious consumers. Dental professionals can promote patients' oral health by educating them about the impact of common convenience foods on the caries process and guiding them toward more healthful choices.

Parental Influence

Parental influence also plays a role in diet choices, especially those of children and adolescents [39]. Because parents generally purchase the foods available for snacking and family meals, they have a high level of control over what foods are eaten by their children.

Children tend to emulate their parents' food choices [39,40]. Parents' food choices and nutritional guidance can be driven by habits, myths, misinformation, weight control efforts or problems, availability, and their own nutritional knowledge [17,41]. Other factors that influence dietary choices include cultural preferences, parenting styles, and family dynamics [17]. Dental professionals should guide parents to not buy sodas and low-nutrient foods in an effort to discourage the formation of habits such as snacking and soda consumption that can contribute to caries. Parents may need to be guided to make healthy, affordable choices for themselves and their families. Also, parents can limit snacking by not allowing children to eat while watching television or playing video games. Educating parents about their influence and guiding them toward healthy food choices can benefit the entire family.

Habit

Eating habits start early and may be difficult to change, especially as time solidifies these behaviors [39,42]. Habits such as eating at the table, having a healthy breakfast, and eating fruits and vegetables can and should start in childhood; however, it is never too late to start these beneficial habits [40,43]. Through discussing habits with patients, dental professionals can encourage behaviors that will promote oral health and identify caries-promoting practices that need to be altered.

Cost

The cost of food is a factor that influences dietary choices for many people. Foods with low nutritional value are often more affordable and more easily accessible than foods with high nutritional value. Fresh fruits, vegetables, and lean proteins are more costly per serving than alternatives that are higher in sugar and fermentable carbohydrates [44]. In addition, there is an inverse relationship between calories and cost per serving: Nutritionally deficient foods such as those with high sugar, fermentable carbohydrate, and fat content are among the most affordable dietary choices [45].

When recommending diet modifications to patients, dental professionals need to consider food costs for many reasons. Studies show that persons of low socioeconomic status tend to live in neighborhoods known as food deserts, where good quality, nutritional foods are scarce and transportation and the time needed to get to nutritional food sources factor into the cost of food [46]. Due to the higher costs associated with healthier foods, people with low incomes incur the highest risks of diet-related conditions [47].

Media

Media have an impact on diet in two ways. Children ages 8 to 18 spend approximately 7.5 hours every day with media, including television, the Internet, music, magazines, cell phones, and tablets. Marketing of foods and snacks to children tends to be geared toward low-nutrition foods and beverages [48]. Media influence diet choices, especially those of children, by the sheer number of food-related advertisements found on television, in print, and on cell phones and tablets—which can evade parental monitoring [48].

By realizing the factors that affect patients' diets, dental professionals are more likely to recommend diet changes to which patients will be willing to adhere. Also, dental professionals can educate patients about these factors to facilitate self-assessment of dietary influences.

6. POPULATIONS AT RISK

Certain populations are at increased risk for caries formation due to diet, habits, lack of adequate oral hygiene, and other factors. These populations can especially benefit from nutritional counseling and caries prevention applications and procedures.

CHILDREN

Because all teeth, once erupted, are susceptible to dental caries, even very young children are vulnerable. Early childhood caries (ECC) is defined as the presence of one or more decayed, missing (due to caries), or filled tooth surfaces in the primary dentition of a preschool-age child [49]. This condition is seen throughout the general population but is more common in the poor and near-poor preschool children. In the United States, it is estimated that between 3% and 6% of children have early childhood caries [50]. The National Institute of Dental and Craniofacial Research (NIDCR) has indicated that between the years of 2011–2016 that 23% of children between the ages of 2 and 5 years had carious lesions in their primary teeth and that children from lower-income families were twice as likely to have decay in their primary teeth compared to children from higher-income families [51]. Among children ages 6 to 11 years, 17% had decay in their permanent teeth [51].

To prevent ECC development, the American Academy of Pediatric Dentistry (AAPD) recommends that children have their first dental appointment soon after their first tooth erupts and no later than their first birthday [49]. Educating the child's primary caregiver about oral hygiene care for the child and proper use of bottles is one of the main objectives of this appointment. Sodas, juices, and other sugared drinks should not be given to children, or they should be given very sparingly, and they should never be dispensed through a bottle. Children using bottles should not be allowed to go to sleep with them unless the bottle contains water. The AAPD also advises eliminating the use of a baby bottle by age 12 months and avoiding foods and drinks that contain sugar for children under 2 years of age [49].

Parents and primary caregivers need to be reminded about the eruption pattern of teeth and the fact that children have new teeth exposed to the oral environment from age 6 months to approximately age 12 years. The enamel of primary teeth is thinner and less organized compared to the enamel of permanent teeth, so the former is more susceptible to demineralization and the formation of carious lesions compared to the latter [50]. Therefore, soda, sugar, and fermentable carbohydrate exposure is more detrimental in youth than in adults.

ADOLESCENTS

The incidence of caries continues to rise as children grow into teenagers. According to the NIDCR, approximately 57% of adolescents between ages 12 and 19 have had carious lesions in their permanent teeth [52]. Adolescence is a time of increased caries risk because teenagers consume diets that are higher in fermentable carbohydrates and sugars, and they often practice poor oral hygiene.

Research shows that this age group responds to health behavior change requests through motivational interviewing (MI) techniques, rather than the traditional dissemination of information and dispensing of advice [53]. Motivational interviewing, a collaborative, goal-oriented form of communicating behavior change, has been shown to positively affect adolescents' change in diet, exercise, and compliance with medications. MI techniques that will help professionals better communicate oral healthcare principles with this age group and the mechanisms by which MI works to instill behavioral changes in adolescents is an area of continued research [54]. Among high school students between 2019–2021, approximately 16.5% of boys and 12.7% of girls had consumed one or more sugar-sweetened soda beverages each day [55,88]. Soda is included with other sugary products and those made with solid fats in the category of empty calories. Empty calories account for 30.2% to 34.4% of 9- to 13-year-olds' daily caloric intake and 30.5% to 35.5% of that of 14- to 18-year-olds [56]. Utilizing the principles of MI, the dental professional can work with each teenager to find easily accessible and tasty alternatives to sugar-laden foods. The Resources section contains links to websites that can be shared with young patients and their parents.

Many adolescents have braces or other orthodontic appliances that complicate oral hygiene. The combination of susceptible tooth surfaces, a high-sugar diet, and poor oral hygiene is the perfect recipe for caries formation.

To decrease caries risk in the adolescent population, medical and dental professionals should inform teenagers about the impact of diet choices on teeth and educate them about healthy eating. Minor changes such as limiting soda consumption to mealtimes and brushing after meals can have a large impact on caries development. In addition, the use of fluoride and sealants is extremely beneficial in preventing caries in the adolescent population.

Adolescents are forming habits that will be a foundation for their adult life. Healthy eating, limiting snacks and sugars, and good oral hygiene will be invaluable practices that will help protect their teeth from caries.

OLDER ADULTS

Older adults are at increased risk for caries as a result of gingival recession, reduced saliva flow, inadequate oral hygiene, physical and sensory limitations, and cognitive limitations [57]. In the United States alone, the elderly population (i.e., those age 65 and older) will grow to 20% (72 million) by 2030 [57,58]. Aging baby boomers who have retained more of their teeth and have undergone more complex dental procedures will have a greater exposure to dental caries and periodontal concerns, as well as greater expectations of their dental care providers [57,59]. Many studies have found root surface caries to be most prevalent in the elderly population [60].

Ideal oral hygiene may be difficult to achieve, as manual dexterity often becomes limited in elderly patients. The presence of partial dentures also complicates oral hygiene, as food and plaque frequently accumulate where the dentures rest against the natural tooth structure. Educating elderly patients who wear partial dentures, and their caregivers when applicable, concerning proper oral hygiene is essential to protect the teeth adjacent to partials from caries. Practices such as cleaning the mouth after meals with fluoridated toothpastes and rinses, removing partials when performing oral hygiene, removing partial dentures before going to bed, paying attention to dietary intake, and using prescription-strength fluoride gels or toothpastes should be encouraged in these patients [59,61].

Elderly patients also consume an elevated amount of fermentable carbohydrates and sugars, further increasing their caries risk. Missing teeth, poorly fitting prosthetics, and tooth mobility due to periodontal disease may make eating fresh fruits, vegetables, and high-fiber foods difficult. To replace these items in their diet, elderly patients are more likely to consume breads, cakes, pies, and food replacement drinks, as these substances are easy to prepare and eat [59]. In addition, elderly patients may suck on hard candies and eat sugary snacks throughout the day to combat the symptoms of xerostomia.

Special considerations need to be taken into account when recommending dietary changes to elderly patients. Food cost, level of difficulty of preparation, and ease of mastication are factors that must be taken into account when advising dietary changes. Replacing candies with a sugar-free variety, limiting snacks, and adding calcium-rich foods such as cheese to their diet are a few of the measures that older adults can take to reduce caries risk. The use of power toothbrushes and fluoride may also be helpful in reducing caries incidence in this population.

PATIENTS WITH XEROSTOMIA

Xerostomia is the subjective description of dry mouth, which can be caused by any number of events [62]. Dry mouth can be a transient reduction or loss of saliva as a result of salivary gland dysfunction. It places patients at a higher risk for caries because saliva contains buffers to neutralize acids in the mouth. Adequate saliva is important for several reasons. The presence of calcium and phosphate in the saliva aids in the remineralization of tooth surfaces [63]. Saliva also helps to naturally cleanse teeth, protects the oral mucosa from mechanical injury, facilitates chewing and swallowing, and inhibits bacterial growth [64,65].

Saliva production can decrease with age [59,66]. Moreover, some medications are commonly associated with xerostomia. More than 500 medications have reduced saliva as a side effect [62,67]. The main medication classes associated with xerostomia include antidepressants, antihypertensives, antihistamines, antipsychotics, sedatives, anorexiants, antiparkinsonism agents, opioids, muscle relaxants, and diuretics [65]. Head and neck radiation therapy and the autoimmune disease Sjögren syndrome are other common causes of salivary gland dysfunction that results in dry mouth [62,68].

Remedies for reducing the effects of xerostomia vary, and recommendations should be patient specific. Depending on a patient's age and cognitive ability, dental professionals should encourage them to chew sugar-free gum, use sugar-free candies, or sip water to reduce the exposure to sugars. The use of over-the-counter saliva substitutes for oral lubrication also helps to increase patients' comfort. Prescription medications designed to stimulate saliva flow may also be recommended for patients who have undergone radiation treatment and for those with Sjögren syndrome. However, efficacy, side effects, and compliance must be weighed against the benefits of using these medications [67,69]. Patients experiencing xerostomia need to demonstrate excellent oral hygiene and may benefit from fluoride and other caries prevention treatments such as the application of in-office fluoride varnish or in-office fluoride treatments [70].

7. CARIES PREVENTION PRODUCTS AND PROCEDURES

FLUORIDE

Fluoride has been used for more than 80 years to prevent dental caries [70]. Demineralization and remineralization are natural processes, as minerals are lost and returned to the tooth surface during the day [71]. Fluoride strengthens enamel, making it more resistant to the acids that promote demineralization and facilitate the development of carious lesions. It also enhances the remineralization of impaired tooth surfaces [72]. Erupted teeth accrue the most benefit from fluoride when its salivary concentration is incorporated into the biofilm that adheres to the teeth [72]. Although it is a bit controversial, water fluoridation is one method of achieving these conditions [70,72]. Approximately 72.7 of U.S. communities have fluoridated water as of 2020 [55]. Bottled water does not contain enough fluoride to prevent dental caries, so patients who drink only bottled water must be educated about the benefits of the topical fluoride found in toothpaste, oral rinses, and prescription-strength fluoride supplements [70,73]. Parents of young children should be aware that multiple forms of fluoride ingestion can lead to fluorosis, that is, detectable changes in the tooth surface that can discolor the tooth but that do not adversely affect tooth strength [72].

Fluoridated water, toothpastes, and mouth rinses are advisable for the general population and especially for caries-prone patients because the use of a fluoride mouth rinse in conjunction with the use of a fluoridated toothpaste enhances enamel fluoridation and remineralization [72]. The use of prescription-strength fluoride toothpaste (1.1% neutral sodium fluoride) may be advantageous to and is usually well tolerated by patients consuming caries-promoting foods, orthodontic patients, patients with xerostomia, and those demonstrating substandard oral hygiene [72].

In-office fluoride treatments may help patients reduce dental caries. Treatments come in a variety of forms, including foams, gels, rinses, and varnishes. The application of 5% sodium fluoride varnish twice a year on the primary and permanent teeth of children ages 6 months through 15 years is beneficial in preventing caries in this age group as well as for the permanent teeth of adult patients [10,70]. The use of in-office professionally applied fluoride gel or foam at 3- to 12-month intervals provides the most preventive benefit for those do not consume fluoridated water and/or whose at-home oral hygiene is substandard [74].

XYLITOL

Xylitol, a sugar alcohol (polyol), is a sugar substitute that helps to prevent dental caries because oral bacteria are unable to break it down to an acid [49,75]. Xylitol also inhibits plaque formation, especially that of mutans streptococci, and has been shown to contribute to remineralization [76,77].

Nutritionally, xylitol has fewer calories than sugar—2.4 calories per gram versus approximately 4.0 calories per gram of sugar [76]. It is also safe for diabetic patients to consume, making it a wise choice for replacing sugar in patients' diets for reasons beyond caries control because xylitol lowers the insulin response compared to foods sweetened with sorbitol or ordinary sugar [78]. Replacing sugar with xylitol has been shown to cause a statistically significant reduction in S. mutans, which is the primary cariogenic bacterial species [79].

New studies are seeking to determine the efficacy and optimal dosage of erythritol, another polyol, for caries prevention. The efficacy of polyols to prevent caries when used to sweeten gum, candy, and food may be confounded by the presence of natural and added fluoride in the diets of the study participants. Some studies have revealed that the combination of xylitol and fluoride can reduce the biofilm in which the cariogenic bacteria reside [80].

Dosage recommendations for xylitol as an anticaries agent include several small exposures during the day, with a plateau effect for the reduction of the cariogenic bacterium S. mutans noted between 6.88 grams per day and 10.32 grams per day [76]. This can be accomplished by using toothpastes, gums, and mints that contain xylitol and using xylitol as a sugar replacement to sweeten foods and drinks. Xylitol can also be used in place of sugar in baking, but patients should be cautioned that consuming large quantities of xylitol may cause gastrointestinal upset.

SEALANTS

The pits and fissures of teeth can be especially caries prone, and applying sealants here is a component of a comprehensive approach to caries management [4]. Pits and fissures in the occlusal, buccal, and lingual surfaces retain food particles and plaque, thus complicating oral hygiene efforts. Consequently, these surfaces are the predominant areas of dental caries. Pit and fissure sealants have been employed to prevent pit and fissure dental caries since the 1960s and remain an excellent method of reducing risk for dental caries. A 2016 systematic review suggests that well-placed occlusal sealants protect the pits and fissures from caries development better than fluoride varnish application does [4]. The review in no way recommends forgoing fluoride application to protect occlusal surfaces from caries. Rather, it states that the available evidence supports the use of both preventive measures where appropriate. Clinicians need to use a combination of assessment and diagnostic tools to determine the best treatment plan for preventing decay and preserving tooth structure in individual patients.

In order to identify pits and fissures that are suitable for the application of preventive sealants or other minimally invasive procedures, dental examinations should include the clinical evaluation of tooth surfaces visually and with the use of a blunt explorer; laser detecting device; compressed air; and the newest addition to caries classification, the International Caries Detection and Assessment System [81]. The ICDAS system is an evidence-based process for identifying and classifying dental caries lesions using visual cues [82]. This method of classifying carious lesions allows clinicians to apply appropriate evidence-based preventive and minimally invasive treatment methods to affected tooth surfaces. Using a scale of 0 (sound) to 6 (extremely decayed) to classify each pit and fissure, clinicians can safely determine the best practice for treating the surface, which can include no treatment, fluoride application, sealants, or restorative procedures [82].

8. CARIES RISK ASSESSMENT

Dental caries is a multifactorial disease. Counseling a patient who is at risk for caries requires the clinician to consider the various factors that can put patients at risk for, or protect them from, dental caries. In addition to caries-promoting diets and belonging to one or more of the high-risk populations discussed previously, the following are factors that can increase an individual's caries risk [15,28,83]:

- Poor oral hygiene

- Family history of poor dental health

- Prolonged bottle- or breastfeeding

- High bacterial titers of S. mutans

- Intermittent dental care

- Mental or physical disabilities that limit oral hygiene ability

- Numerous multisurface restorations

- Restorations with open or overhanging margins

- Orthodontic appliances

- Enamel defects and genetic tooth abnormalities

- Radiation or chemotherapy treatments

- Eating disorders

- Alcohol and drug abuse

- Smoking and vaping

Determining a patient's caries risk level, and therefore the relative importance of nutritional counseling and other interventions, requires consideration of these factors and communication with the patient and/or patient's parent. Some of these factors can be identified during the dental examination, such as recession, multisurface restorations, and enamel defects. Other factors, such as personal and family dental history, are elusive and require an open dialogue with the patient and/or patient's parent [84].

There are several caries risk assessment tools available [4,84]. Practitioners need to find a tool that allows them to evaluate the variety of factors associated with caries risk as they begin to discuss how diet and nutrition affect the patient's risk for caries. Caries risk assessments categorize patients into one of three categories. A patient at low caries risk exhibits no caries risk factors and a dental history of no incipient or active caries lesions in the past three years. Patients at moderate risk for caries include those that had either one or two incipient or active caries lesions in the past three years or no caries history in the past three years but at least one caries risk factor. High caries risk is the determination given to patients who have developed three or more caries lesions (incipient or active) in the past three years, have low fluoride contact, present with multiple caries risk factors, or have severe xerostomia [85].

Separate caries risk assessment forms for patients ages 0 to 6 years and for patients older than 6 years can be found on the ADA website at http://www.ada.org/en/member-center/oral-health-topics/caries. Use of these forms will facilitate and standardize the dental team's caries risk assessment. In addition, the use of risk assessment forms can help uncover the role of poor nutrition as a risk factor and allow the topic of nutrition to be more effectively woven into the risk reduction discussion.

9. NUTRITIONAL COUNSELING

All patients stand to benefit from nutritional counseling. Once a caries risk level has been established, all patients should be counseled on how their diet affects their teeth, their caries risk, and their general oral health. Personalized oral hygiene instructions should be established for each patient. Those patients identified as being at moderate to high risk for caries may need to have nutritional counseling and preventive measures not just discussed but also incorporated into their treatment plans.

Dental caries is a preventable disease. However, a high incidence of caries in early childhood is the single strongest predictor of the development of carious lesions into adolescence and adulthood [86]. For patients at low to low-moderate risk for dental caries, nutritional counseling may be performed at the dental cleaning, or recare, appointment. Questions regarding diet, such as those listed later in this section, may be asked on the medical history form or directly of the patient by the dental professional. For these patients, the goal of nutritional counseling is education designed to maintain their low caries risk level.

THE NUTRITIONAL COUNSELING APPOINTMENT

Patients with a moderate- to high-risk level of caries may benefit from a separate nutritional counseling appointment. The appointment length is individualized based on the patient's dental knowledge, dietary habits, and motivation level. During this appointment, the dental professional and patient have an opportunity to evaluate the patient's current diet, discuss preventive treatments, and set goals to improve the diet and reduce caries incidence.

To gain information concerning dietary habits, the dental professional may have patients complete a diet questionnaire and food log [87]. An example of a dietary questionnaire and food log was previously shown in Table 1. Alternatively, the dental professional may choose to interview patients concerning dietary habits, using questions such as:

- What are your favorite snacks?

- On a typical school or workday, what do you eat for lunch?

- What is your favorite soft drink or fruit juice, and how often do you drink it?

- How long does it take you to finish a can of soda or a glass of juice?

- How often do you brush your teeth? How often do you floss?

Follow-up to the nutritional counseling appointment should take place in order to encourage the patient's goals and reinforce habit changes. This follow-up may consist of a phone call to check in with the patient, or it may be a short appointment a few weeks after the counseling appointment. The patient's progress can be reevaluated at subsequent dental appointments.

Establishing and routinely reassessing a patient's caries risk level allows the dental professional to provide proactive care and recommend preventive measures to minimize the patient's risk of dental decay.

Occasionally, a patient may benefit from a referral to a dietician, nutritionist, or primary care physician. This is especially true if a condition such as acid reflux, an eating disorder, or chemical dependency is suspected or confirmed.

SETTING GOALS

The dental professional should be practical when recommending changes to a patient's diet. Asking patients to forfeit their favorite foods in exchange for increased brushing and flossing will rarely improve patient compliance. It is important to note, however, that relatively minor changes in nutrition and habits can lower a patient's caries risk. By evaluating each patient's individual incentives and motivation level, dental professionals can help patients set goals that are realistic and achievable.

Some examples of these goals are:

- Limiting soda drinks to mealtimes

- Exchanging sugared gum or candies for sugar-free or xylitol-sweetened varieties

- Replacing soda with flavored water

- Including sweet foods with meals, when the sugar content will be diluted

- Making a conscious effort to eat a fruit or vegetable with every meal, as fruits and vegetables act as natural oral cleansers

- Brushing with a xylitol-containing toothpaste and chewing xylitol gum twice a day

As patients set and achieve goals, additional changes can be recommended to further decrease caries risk. Nutritional counseling, like other behavioral modification interventions, is a dynamic process that is emphasized depending on need.

10. CASE SCENARIOS

CASE SCENARIO 1: SAVANNAH'S FIRST DENTAL APPOINTMENT

Savannah is a 4-year-old girl coming to your office for the first time. She is wearing a pretty dress and sparkly shoes, and she has a pink bow tying her long black hair up in a ponytail. She is obviously frightened. As you escort Savannah and her mother to the treatment room, the only thing Savannah says is that she does not want silver teeth. Savannah has an unremarkable medical history, takes no medications, is current with her vaccinations, and has no allergies. When you ask Savannah if any of her teeth hurt, she quietly nods. Upon being asked whether Savannah has been to the dentist, her mother explains that Savannah lived with her aunt for several months and during that time had been taken to her aunt's dentist. Her aunt's dentist had recommended stainless-steel crowns for Savannah's carious teeth #E and #F, but the aunt did not want to have the crowns placed without Savannah's mother's permission. Savannah is covered by insurance, but the insurance pays only for stainless-steel crowns, and Savannah's mother admits to having been unable to afford the tooth-colored crowns until now.

Establishing a caries risk level for this child should be easy, as her mother admits that she has active carious lesions. What is her caries risk level? One look at Savannah's cute smile reveals severe caries on teeth #E and #F. At this point, you complete the caries risk assessment form, determining the child's fluoride exposure level, oral hygiene routine, and snacking habits. Savannah's mother works full time and has two children, Savannah and her 3-year-old sister, Lillian. Savannah's mother admits that the girls don't brush their teeth regularly, as they commonly fall asleep in front of the television and are carried to bed. A typical breakfast consists of sweetened cereal, milk, and a juice box. They eat lunch at the babysitter's, and their mother tries to make them sit down to have dinner each night. The girls like to eat candy after dinner, frequently not eating all their dinner in order to save room for the candy.

Treating Savannah's oral conditions will be a long process. Because her caries risk is high, each appointment should include a short nutritional counseling session, which can be added to the treatment plan. If Savannah were your patient, what would be your plan for preventing new carious lesions? What would you consider to be a manageable step 1 for this child?

Discussion

Treatment Plan

Savannah has ECC, with several carious lesions in each quadrant needing extensive restorative intervention. Her mother does not want her sedated, so the restorations will require no fewer than five appointments.

Vision for Preventing New Carious Lesions

Restore all existing cavitated lesions, promote remineralization of the noncavitated lesions, develop excellent oral self-care habits, and perform preventive dental hygiene care every four to six months until no new caries activity has been observed for a period of three years. In other words, the goal is to reduce Savannah's caries risk to low. It is imperative to break the chain of the four elements required for caries activity: Caries-causing micro-organisms, a susceptible tooth surface, fermentable carbohydrates, and time.

What Would You Consider to be a Manageable Step 1?

Initial examination should include simple nutritional counseling and thorough oral hygiene instruction that includes both the mother and child. Poor oral hygiene and eating habits are difficult to change. A good first step may be to give the family the goal of brushing their teeth after each meal. Discuss the bacteria and food that remain on teeth after eating and how they need to be removed after each meal. Comparing this process to the habit of washing hands before each meal to remove bacteria and dirt may help the child make the connection. Have Savannah's mother complete the Nutritional Questionnaire and Food Log and bring it to the next nutritional counseling session.

CASE SCENARIO 2: HE'S GOT ALL THE ANSWERS

Mr. Ribeiro, a 68-year-old male, arrives for his dental hygiene recare appointment. He is a pleasant, retired gentleman. He appears happy, healthy, and quiet, as usual. His medical history is unchanged from his last visit six months ago. He has high blood pressure and prostate malfunction. He takes losartan, finasteride, and terazosin. He has no dental complaints. During your oral health and caries risk assessment, you detect very little plaque biofilm, no bleeding on probing, stable periodontal health, adequate saliva flow, a broken cusp on tooth #31, and what appears to be a recurrent carious lesion under the crown on tooth #8. As you complete your caries risk assessment, your first inquiry goes as follows:

Q: How often do you brush?

A: Three times a day.

Q: How do you clean in between your teeth?

A: I use that flosser thing three times a day.

Q: Do you snack?

A: Not very often.

Q: What do you drink when you're thirsty?

A: Water.

Discussion

Dental professionals commonly see this scenario. The patient knows all the right answers, and you can't dispute his oral health routine, as his periodontal condition is excellent. However, he does have recurrent decay on tooth #8.

What follow-up questions might you choose to ask to fill in the blanks about the role his nutritional intake may play in this case?

Recalling the four factors necessary for the caries disease progression—susceptible tooth, diet, time, and bacteria—you need to be a bit of a detective. Mr. Ribeiro's history of dental care also includes several crowns and a recent restoration. This tells you that his teeth are susceptible. He maintains a clean mouth, or so he says, so you must consider that he removes the oral bacteria from his teeth regularly. Diet may be the culprit.

A good way to begin with a patient who knows all the right answers and does not want to be lectured might be to go through your caries risk assessment out loud. Begin by telling him why you are asking these questions. Tooth decay is preventable, and you want to help him prevent the need for more costly crowns and fillings in the future. Ask him to tell you what he has eaten in the past 24 hours. Share with him that even though he brushes three times a day, the bacteria and acids on his teeth will eventually begin to demineralize his teeth. Often, letting that fact form a picture in a patient's head can spur questions or even solutions for reducing the risk. Change is most likely to happen when the patient is a partner in the change.

11. CONCLUSION

Many patients take oral health for granted and will benefit from learning that caries is a preventable disease, and their dietary choices can either promote the progression of disease or aid in preventing caries development. Addressing nutritional choices during dental visits can positively affect patients and can help them make healthier choices for their entire family. Dental professionals as a community have the ability to educate hundreds of thousands of people. Taking the time to discuss nutrition with patients will pay the dividend of having healthier patients who truly value their teeth and overall health. As patients come to understand the relationship between oral health and systemic health, the impact of their dietary choices on both will become evident.

12. RESOURCES

Academy of Nutrition and Dietetics

1-800-877-1600

http://www.eatright.org

American Dental Association: Diet and Dental Health

http://www.mouthhealthy.org/en/az-topics/d/diet-and-dental-health

American Dental Association: Diet and Nutrition

http://www.ada.org/en/advocacy/advocacy-issues/diet-and-nutrition

Centers for Disease Control and Prevention

CDC Healthy Schools: School Nutrition

https://www.cdc.gov/healthyschools/nutrition/schoolnutrition.htm

Minnesota Dental Association: Sip All Day, Get Decay!

http://www.sipallday.org

National Association of Nutrition Professionals

1-800-342-8037

http://www.nanp.org

National Heart, Lung, and Blood Institute

We Can! Parent Tips: Making Healthier Food Choices

http://www.nhlbi.nih.gov/health/public/heart/obesity/wecan/downloads/tip_choices.pdf

U.S. Department of Health and Human Services

Dietary Guidelines Advisory Report

http://health.gov/dietaryguidelines/2015

U.S. Department of Agriculture

ChooseMyPlate

http://www.choosemyplate.gov

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50201 • Botulinum Toxin and Dermal Fillers for Facial Aging

Mark Rose, BS, MA, LP

www.netce.com

Copyright © 2024 NetCE, All rights reserved.

The importance for primary care clinicians to understand aesthetic medicine, patient variables, and market factors is brought to light by the increasing rates of aesthetic injections performed by non-board-certified physicians, nurses, and minimally trained aestheticians at inadequately equipped clinics, office settings, and spas. Primary care providers are well-placed to importantly inform their patients about many aspects related to aesthetic medicine but benefit from educational intervention to become most effective in this role.

Table of Contents

50201 • Botulinum Toxin and Dermal Fillers for Facial Aging

Course Overview

Audience

Accreditations & Approvals

Designations of Credit

Course Objective

Learning Objectives

Faculty

Faculty Disclosure

Division Planner

Division Planner Disclosure

Director of Development and Academic Affairs

Director Disclosure Statement

About the Sponsor

Disclosure Statement

Implicit Bias in Health Care

1. INTRODUCTION

2. TERMINOLOGY

3. BACKGROUND

INCREASING CONCERNS

4. THE PROCESSES OF FACIAL AGING

THE TWO-DIMENSIONAL MODEL

THE 3-D MODEL: NORMAL ANATOMY OF FACIAL TISSUE

THE INTEGRATIVE AND AESTHETIC UNITS PERSPECTIVES

5. BOTULINUM TOXIN

DISCOVERY AND DEVELOPMENT

MECHANISM OF ACTION

AVAILABLE PRODUCTS AND FORMULATIONS

CLINICAL USE OF BOTULINUM TOXIN

6. SOFT TISSUE (DERMAL) FILLERS

HYALURONIC ACID

CALCIUM HYDROXYLAPATITE

POLY-L-LACTIC ACID

POLYMETHYLMETHACRYLATE MICROSPHERES

FILLER SELECTION

7. DEOXYCHOLIC ACID

8. INDIVIDUALIZED ASSESSMENT AND TREATMENT PLANNING

KEY ASSESSMENT ELEMENTS

ETHNIC CONSIDERATIONS

GENDER CONSIDERATIONS

AGE CONSIDERATIONS

9. THE MINIMALLY INVASIVE TREATMENT APPROACH

RECOMMENDED THERAPY COMBINATIONS

RECOMMENDED THERAPY SEQUENCE

PATIENT-TAILORED TREATMENT

THE TRI-VECTOR TECHNIQUE

THE UPPER FACE

THE MIDFACE

THE LOWER FACE AND NECK

THE NECK

10. PATIENT SELECTION AND EVALUATION

SCREENING AND SELECTION

PATIENT EVALUATION AND CONSENT

11. ADVERSE EFFECTS

PREVENTION AND RISK REDUCTION

COMMON ACUTE SIDE EFFECTS

INFREQUENT ACUTE ADVERSE EVENTS

VASCULAR COMPROMISE

ALLERGIC/HYPERSENSITIVITY REACTIONS

DELAYED COMPLICATIONS: INFLAMMATION OR INFECTION?

12. CONCLUSION

Works Cited

Evidence-Based Practice Recommendations Citations

50201 • Botulinum Toxin and Dermal Fillers for Facial Aging

Education Category. Medical / Surgical

Release Date. 04/01/2024

Expiration Date. 03/31/2027

Course Overview

The importance for primary care clinicians to understand aesthetic medicine, patient variables, and market factors is brought to light by the increasing rates of aesthetic injections performed by non-board-certified physicians, nurses, and minimally trained aestheticians at inadequately equipped clinics, office settings, and spas. Primary care providers are well-placed to importantly inform their patients about many aspects related to aesthetic medicine but benefit from educational intervention to become most effective in this role.

Audience

This course is designed for dental professionals who may administer or care for patients who have undergone aesthetic procedures.

Accreditations & Approvals

NetCE Nationally Approved PACE Program Provider for FAGD/MAGD credit. Approval does not imply acceptance by any regulatory authority or AGD endorsement. 10/1/2021 to 9/30/2027 Provider ID #217994. NetCE is an ADA CERP Recognized Provider. ADA CERP is a service of the American Dental Association to assist dental professionals in identifying quality providers of continuing dental education. ADA CERP does not approve or endorse individual courses or instructors, nor does it imply acceptance of credit hours by boards of dentistry. Concerns or complaints about a CE provider may be directed to the provider or to ADA CERP at www.ada.org/cerp. NetCE is approved as a provider of continuing education by the Florida Board of Dentistry, Provider #50-2405. NetCE is a Registered Provider with the Dental Board of California. Provider Number RP3841. Completion of this course does not constitute authorization for the attendee to perform any services that he or she is not legally authorized to perform based on his or her license or permit type.

Designations of Credit

NetCE designates this activity for 10 continuing education credits. AGD Subject Code 780. This course meets the Dental Board of California's requirements for 10 unit(s) of continuing education. Dental Board of California course #10-3841-26415.

Course Objective

The purpose of this course is to provide clinicians with the knowledge necessary to provide minimally invasive aesthetic procedures and to care for patients who have undergone these procedures.

Learning Objectives

Upon completion of this course, you should be able to:

1. Outline the background of aesthetic medicine and botulinum toxin/filler use.

2. Describe the process of usual facial aging.

3. Discuss the mechanism of action and clinical use of botulinum toxin for the treatment of facial aging.

4. Compare and contrast the classes of dermal filling agents available.

5. Analyze components that affect the appropriate selection of dermal filling agent.

6. Describe key aspects of individualized assessment of patients seeking aesthetic treatments for facial aging.

7. Outline the minimally invasive approach to the treatment of facial aging.

8. Evaluate patient-related factors affecting suitability for various aesthetic treatments.

9. Identify acute and potentially severe side effects of botulinum toxin/filler use.

10. Discuss the role of biofilm infections in delayed reactions to dermal fillers.

Faculty

Mark Rose, BS, MA, LP, is a licensed psychologist in the State of Minnesota with a private consulting practice and a medical research analyst with a biomedical communications firm. Earlier healthcare technology assessment work led to medical device and pharmaceutical sector experience in new product development involving cancer ablative devices and pain therapeutics. Along with substantial experience in addiction research, Mr. Rose has contributed to the authorship of numerous papers on CNS, oncology, and other medical disorders. He is the lead author of papers published in peer-reviewed addiction, psychiatry, and pain medicine journals and has written books on prescription opioids and alcoholism published by the Hazelden Foundation. He also serves as an Expert Advisor and Expert Witness to law firms that represent disability claimants or criminal defendants on cases related to chronic pain, psychiatric/substance use disorders, and acute pharmacologic/toxicologic effects. Mr. Rose is on the Board of Directors of the Minneapolis-based International Institute of Anti-Aging Medicine and is a member of several professional organizations.

Faculty Disclosure

Contributing faculty, Mark Rose, BS, MA, LP, has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Division Planner

Mark J. Szarejko, DDS, FAGD

Division Planner Disclosure

The division planner has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Director of Development and Academic Affairs

Sarah Campbell

Director Disclosure Statement

The Director of Development and Academic Affairs has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

About the Sponsor

The purpose of NetCE is to provide challenging curricula to assist healthcare professionals to raise their levels of expertise while fulfilling their continuing education requirements, thereby improving the quality of healthcare.

Our contributing faculty members have taken care to ensure that the information and recommendations are accurate and compatible with the standards generally accepted at the time of publication. The publisher disclaims any liability, loss or damage incurred as a consequence, directly or indirectly, of the use and application of any of the contents. Participants are cautioned about the potential risk of using limited knowledge when integrating new techniques into practice.

Disclosure Statement

It is the policy of NetCE not to accept commercial support. Furthermore, commercial interests are prohibited from distributing or providing access to this activity to learners.

Implicit Bias in Health Care

The role of implicit biases on healthcare outcomes has become a concern, as there is some evidence that implicit biases contribute to health disparities, professionals' attitudes toward and interactions with patients, quality of care, diagnoses, and treatment decisions. This may produce differences in help-seeking, diagnoses, and ultimately treatments and interventions. Implicit biases may also unwittingly produce professional behaviors, attitudes, and interactions that reduce patients' trust and comfort with their provider, leading to earlier termination of visits and/or reduced adherence and follow-up. Disadvantaged groups are marginalized in the healthcare system and vulnerable on multiple levels; health professionals' implicit biases can further exacerbate these existing disadvantages.

Interventions or strategies designed to reduce implicit bias may be categorized as change-based or control-based. Change-based interventions focus on reducing or changing cognitive associations underlying implicit biases. These interventions might include challenging stereotypes. Conversely, control-based interventions involve reducing the effects of the implicit bias on the individual's behaviors. These strategies include increasing awareness of biased thoughts and responses. The two types of interventions are not mutually exclusive and may be used synergistically.

1. INTRODUCTION

Visibly apparent aging and loss of youthful appearance are frequent concerns of patients seeking cosmetic treatment. Botulinum toxin and dermal (soft tissue) fillers are minimally invasive (i.e., injection-delivered) therapies that, along with knowledge advances, have revolutionized cosmetic treatment of aging features.

The clinical features of aging are the result of bone resorption; ligament laxity; redistribution, volume loss, and descent of facial soft tissue; and formation of lines and folds in inelastic, sagging skin. This complexity is not amenable to single-modality treatment; current practice combines botulinum toxin and fillers as the core approach, with other therapies added. Filling isolated lines or creases is de-emphasized.

In carefully selected patients with strict adherence to safety standards, desired results can be achieved with a low risk to safety. With increasing consumer demand, injector backgrounds and settings have expanded beyond oversight. Rises in catastrophic complications are largely unknown, as the "risk-free" perception of botulinum toxin and fillers continues. Clinicians and patients may be unaware of the range of U.S. Food and Drug Administration (FDA)-approved minimally invasive options, advances in the understanding and addressing facial aging with these therapies, and the potential of serious complications with incorrect use. These areas are the focus of this course.

Beyond the scope of this course are cosmetic surgery (e.g., rhinoplasty, face-lift), reconstructive or rehabilitative surgery, cosmetic concerns of systemic origin (e.g., lipoatrophy from antiretroviral therapy), and nonfacial cosmetic concerns. Laser, energy, and topical therapies are noninvasive interventions for sun-damaged, aged skin and acne scars, but they will not be the focus of this course. Cosmetic medicine is a point of convergence for diverse psychological, social, cultural, and racial factors, all of which should be considered for each patient. The properties of products discussed in this course are unique. This requires reference by commercial brand, but should not be construed as endorsement of any commercial product.

2. TERMINOLOGY

Plastic surgery includes subfields of reconstructive or rehabilitative surgery for congenital malformations or acquired disfigurements, and cosmetic surgery for correction, restoration, or enhancement of appearance[1]. "Aesthetic medicine" was coined to replace "cosmetic medicine/surgery," but the terms remain interchangeable [2].

The cosmetic medicine literature describes features with terms (e.g., defect, defective, deformity, deformation) that carry different meanings outside of this highly specialized professional audience. It is not the intent of this course to imply that normal aging of the face or skin is in any way a defect aside from the patient's perception or desires in terms of appearance. Beauty is a standard that varies by culture, time, age, and personal experiences, and there is no one standard for any facial feature or individual.

Therapeutic goals are variously described as volumizing, re-volumizing, rejuvenation, restoration, harmonization, resurfacing, correction, and others, with little consistency. This course will not attempt to modify terminology used in the published literature, except to improve logical consistency.

3. BACKGROUND

Until the 1990s, facial aging was attributed to gravitational effects that required surgical lifting and tightening to defy soft-tissue descent. Facial aging as a multi-tissue process of descent, volume loss, and resorption was first described in 1965 but remained obscure, and the focus on superficial tissue descent and correction persisted [3,4,5,6].

Botulinum toxin and dermal fillers were introduced to correct cosmetic defects without the need for surgery. Earlier use to spot-correct isolated wrinkles and creases led to temporary but limited benefits, with no advantage over surgical facelift for persons with moderate or advanced aging features [4,5,6,7].

Studies identified soft tissue volume loss and hard tissue resorption as causal to facial aging. This prompted filler injection into deep tissue for re-volumizing; new fillers designed for specific tissue placement; use of lower-dose botulinum toxin to improve outcomes; advances in lasers and energy devices for resurfacing or tightening with minimal recovery time; and evidence of synergistic efficacy and superior cosmetic outcomes with combined therapies [6,7,8]. These advances brought a paradigm shift from "wrinkle-chasing," with isolated clinical benefit, to recognition of facial aging as a complex interaction of extrinsic and intrinsic factors across multiple tissue planes requiring a three-dimensional, multilayered treatment approach [9,10]. Surgical facelift requires patients to wait until visible aging is sufficient to warrant surgery, often with sudden, sometimes unnatural, changes in appearance. Minimally invasive therapy offers a more gradual, natural-looking harmonization preferred by many patients [7].

Botulinum toxin and dermal filler injection techniques are constantly evolving; what was considered state-of-the-art 5 to 10 years ago no longer represents a practice standard [11]. Every year, the American Society of Plastic Surgeons (ASPS) and the American Society for Dermatologic Surgery (ASDS) separately publish the number of procedures performed by their board-certified members. In 2020, ASPS members performed 15.6 million cosmetic procedures—13.2 million nonsurgical (92% female)—at a total cost of $16.7 billion. Among patients who received cosmetic procedures, 66% were White, 12% were Hispanic, 9% were Black/African American, 7% were Asian, and 6% were other [12]. The 4.4 million botulinum toxin and 3.4 million dermal filler procedures reported by ASPS in 2020 represent an increase of 459% compared with 2000 [12]. ASDS members in 2019 performed an additional 2.3 million botulinum toxin (88% female) and 1.6 million filler (90% female) procedures, a 60% and 78% increase from 2012, respectively [13]. The number of cosmetic procedures was down significantly in all categories in 2020 (compared with 2019), likely due to COVID-19.

Between 2012 and 2017, there was a 50% increase in cosmetic procedure requests by persons younger than 30 years of age (90% female), and in 2016, more than 229,000 cosmetic procedures were performed in patients 18 years of age or younger [14,15]. The annual figures by ASPS/ASDS are considered the benchmark for cosmetic procedures, trends, and demand, but they significantly under-represent the actual number of minimally invasive procedures performed outside of their membership [16,17,18,19,20].

INCREASING CONCERNS

As cosmetic treatment methods have evolved, provider backgrounds expanded from specialists in plastic surgery (traditional) to dermatology, ophthalmology, and otolaryngology, then to dentists and registered nurses, followed by licensed aestheticians, unsanctioned medical personnel (e.g., medical assistants), and lay practitioners [17]. As such, the experience and qualifications of injectors is increasingly questionable and unpredictable. A large and growing proportion is performed in medical spas, spas, hair salons, other commercial settings, and at "Botox and filler parties" in private homes by non-healthcare professionals, sometimes without written informed consent [16,17].

There is an increasing number of filler complications from intravascular injection, an immediate, severe event that can result in blindness, tissue necrosis, or stroke, and from bacterial biofilm infection, when filler injection seeds skin-surface bacteria into tissue with the filler product [19]. Biofilm infections may become disfiguring, are often antibiotic-resistant, and are potentially a methicillin-resistant Staphylococcus aureus (MRSA) infection [21]. The increasingly unregulated state of botulinum toxin and filler injection practice, the absence of a universal adverse event reporting mechanism, and potentially powerful financial incentives to conceal complications have prompted calls for greater regulation of providers and practice and for relabeling of filler injections as "dermal implants" to accurately reflect the risks inherent in placing an inanimate object into human tissue [16,17,18,22,23].

The face ages in a unique but relatively consistent manner, creating a distinct but recognizable ''aged'' appearance. As people age, many are left with the feeling that their physical appearance is no longer an accurate representation of their mental state. Some opt to pursue cosmetic procedures for ''matching their outsides with their insides'' [24]. In skilled hands with diligent execution of precautions, the results attainable without surgery can be impressive, with a good safety margin. Improper patient selection, preparation, or technique invites problems ranging from patient dissatisfaction and poor cosmetic outcomes to increased risks of serious and potentially catastrophic complications of intravascular injection or delayed bacterial infections. The idea that botulinum toxin and fillers are risk-free cosmetic treatments is thoroughly dispelled.

4. THE PROCESSES OF FACIAL AGING

In the face, the process of aging that culminates in cosmetic concerns is complex. Changes of the facial skeleton, soft tissue, retaining ligaments, fat compartments, and the skin contribute to the features of facial aging in varying degrees, influenced by intrinsic (e.g., genetic) and extrinsic (e.g., sun exposure) factors [25]. To understand facial aging and appropriate interventions requires multidimensional knowledge of the normal anatomy and physiology of facial tissue layers, age-related changes in histology and morphology in each plane, and their multilevel interactions to form cosmetic features of aging.

Perceptual models used in cosmetic medicine can assist in conceptualizing these changes. Each model views facial aging from a different perspective. Presented in sequence, the models break down the complex, dynamic, multidimensional process into its dimensional components. The predominant models are [4,26,27,28,29,30,31,32]:

- The two-dimensional (2-D) model: Organizes the surface anatomy and superficial cosmetic defects into horizontal zones that anchor morphologic features to familiar anatomic boundaries

- The three-dimensional (3-D) model: Delineates facial anatomy into its underlying tissue layers to describe normal and age-related changes in structure/function at each facial tissue level

- The integrative model: "Zooms out" from the 3-D model to describe how tissue-level changes interact to form the visible features of facial aging

- The aesthetic zones/units model: Describes cosmetic defects of facial aging as changes in underlying and surrounding tissue within anatomically compartmentalized units

All four models will be used later in this course to describe the cosmetic features of facial aging and recommended minimally invasive interventions.

THE TWO-DIMENSIONAL MODEL

To describe the anatomic locations of common cosmetic concerns widely referenced in this course (Table 1), the face is divided into three horizontal zones with defined anatomic boundaries [4,30,31,32]:

Table 1: FACIAL AGING FEATURES

Zone

Cosmetic feature

Description

Upper face

Glabellar rhytides

Vertical lines between the eyebrows

Horizontal forehead rhytides

Horizontal creases on the forehead, exacerbated during brow elevation

Lateral canthal rhytides ("crow's feet")

Multiple periocular lines and wrinkles that radiate lateral to the eye, more prominent when smiling

Brow ptosis (drooping)

Tissue descent that can mimic angry or scowling expressions

Temporal fossa wasting

Concavity of the temple area

Midface

Nasojugal fold (tear trough depression)

Depression between the rim of the orbital bone and the nasal sidewall

"Bunny lines"

Wrinkles on the dorsal and lateral nose during contraction of the upper nasalis muscle

Nasolabial foldsa

Creases extending from the lateral nasal alae to the lateral mouth

Lower face

Perioral lip rhytides ("whistler's wrinkles")

Vertical wrinkles extending from the lip border

Mouth frown

A downward turn of the corners of the mouth

Melomental folds ("marionette lines")

Facial lines extending from the corners of the mouth to the mandible (jaw)

Mental crease

A horizontal groove present on the chin

Peau d'orange chin

Multiple dimples on the chin during contraction of the mentalis muscle

Masseteric hypertrophy

Square appearance to the jawline

Gingival (gummy) smile

Significant upper gum display during smilingb

Neckc

Platysmal bands

Vertical linear bands present on the anterior neck

Horizontal neck lines

Horizontal bands present on the upper neck

aSometimes assigned to the lower face.

bNot necessarily age-related.

cThe neck is usually included in the lower face for three horizontal zones.

Source: [10,33,34]

- The upper face: Forehead, glabella (smooth area between eyebrows), periocular (lateral to the eyes) areas, and temples

- The midface: Between the glabella and tip of nose, lateral to the zygoma (cheekbone). The malar area is highly relevant, as the malar is the cheekbone prominence. The submalar is the bony area underneath the cheekbone.

- The lower face: The perioral area (lips), mandible, chin, and neck

THE 3-D MODEL: NORMAL ANATOMY OF FACIAL TISSUE

The two-dimensional model is a good descriptive framework for cosmetic concerns but does not describe the aging processes of underlying facial tissue that inform their minimally invasive correction. This area is addressed by the three-dimensional model.

The Skin

The skin consists of the epidermis and dermis, mutually dependent layers that rest on the superficial fat layer [35].

Epidermis

The epidermis is the most superficial layer, composed of stratified squamous cells or keratinocytes (90%) and melanocytes (approximately 8%). The epidermis is directly exposed to the environment and its damaging effects. To replace damaged cells, new cells must constantly form and migrate to the surface over two to four weeks [35,36].

Melanocytes produce melanin, which gives pigment to the skin and absorbs ultraviolet (UV) light to prevent DNA damage. Absolute numbers of melanocytes are constant across races. The amount of melanin produced, size of melanosomes, and extent of aggregation account for differences in pigmentation. Epidermal melanocyte density declines with aging [35,36,37].

Dermis

The superficial papillary dermis (20% of the dermis) is loose connective tissue with capillaries, reticular fibers, and some collagen. Small projections (dermal papillae) into the epidermis maintain adhesion between the layers and nourish the epidermis [35,36].

The deeper reticular dermis is dense connective tissue, and the deepest level borders the superficial fat layer. Collagen makes up most of the dermis (75% is collagen type I), providing strength and structure to the skin. Elastin fibers, synthesized by fibroblasts and keratinocytes, give elasticity and resilience. Fibroblasts, the major cell type of the dermis, produce procollagen and elastin fibers [35].

Filling the spaces between collagen and elastin fibers is an extracellular matrix of glycosaminoglycans (hyaluronic acid), chondroitin sulfates, and glycoproteins (carbohydrates or amino sugars linked to a protein) [35,36,38].

The Superficial Fat Layer

The superficial fat layer, consisting of adipose tissue and collagen network, contributes to thermoregulation, shock absorption, wound healing, and immune function. The adipocytes can transform into myofibroblasts to influence local collagen synthesis [39]. Fibrous partitions separate the superficial fat into perioral (around the lips), nasolabial, cheek, and periorbital (around the eye sockets) compartments [40].

In the midface, the malar fat is composed of superficial fat compartments that lie above the superficial fascia. From medial to lateral, they are [25,41]:

- The nasolabial fat

- The superficial medial cheek, middle cheek, and lateral temporal cheek fat

- The inferior infraorbital fat, where under-eye "bags" appear, above the superficial medial cheek

Superficial Musculo-Aponeurotic System

The soft tissue is complex, because active movement over and around the orbital and oral cavities requires a muscle layer within soft tissues that connects with the overlying skin [42]. The superficial musculo-aponeurotic system is an organized fibrous network comprised of the platysma muscle, parotid fascia, and fibromuscular layer covering the cheek. The superficial musculo-aponeurotic system divides the deep and superficial fat, connects the facial muscles to the dermis in a moveable continuous plane, and functions to transmit, distribute, and amplify the activity of all facial muscles [43,44].

Muscles and Ligaments

Muscles of facial expression and muscles that facilitate chewing, smiling, speaking, and blinking alter the tension in adjacent skin, unlike other muscles that attach to bones or tendons. Muscles of facial expression significantly impact facial aesthetics, as repeated contraction can form dynamic rhytids and static lines [44,45,46,47].

The Deep Fat Layer

The deep fat layer is separated from superficial fat by the superficial musculo-aponeurotic system in the midface, platysma in the neck, and superficial temporal fascia in the temples, forming deep fat pads with fibrous ligament partitions [39,40]. Deep fat compartments in the midface are [25,41]:

- The deep cheek fat, which divides into medial (deep and medial to nasolabial fat) and lateral (deep to superficial medial cheek fat) parts. The deep medial cheek extends medially almost to the lateral incisor tooth.

- Medial portion of the buccal fat pad, just lateral to the deep lateral cheek

- The medial and lateral suborbicularis oculi fat, deep to the orbicularis oculi muscle of the lower eyelid

The Deep Fascia

The deep fascia layers are interconnected and secured to the facial skeleton in specific areas by a network of retaining ligaments, perpendicular to the layers and connect all layers to the deep fascia. The deep fascia provides the attachment for ligament origins and is formed by the periosteum on the facial skeleton and by deep muscle fascia where the skeleton is overlain by the masticatory structures [42].

The Facial Skeleton

The facial skeleton forms the scaffold on which soft tissues are draped and has a substantial effect on appearance. The primary bones of the facial skeleton by horizontal zone are [31,46,48]:

- Upper face: The frontal bone (forehead), bordered below by the glabella (smooth area between eyebrows) and frontonasal groove, and laterally by the supra-orbital (above-eye) ridges.

- Midface: Medial and middle thirds of the midface skeleton formed by the maxilla (houses roof of the mouth, extends upward to orbital floor). The lateral third is formed by the zygoma (cheekbone) body and arch.

- Lower face: The mandible (jaw bone) is the primary bone.

The 3-D Model: Age-Related Alteration

Age-related physiologic processes lead to morphologic changes of the facial skeleton, soft tissue, retaining ligaments, fat compartments, and skin. The three-dimensional alterations of facial aging require accurate evaluation to provide patients the optimal aesthetic strategy [25,30,42].

The Facial Skeleton

From prominent bone formation in youth, age-related changes in the relative dynamics of bone expansion and bone loss lead to predominant bone resorption in the aging craniofacial skeleton, an important contributor to facial aging [42,49]. Skeletal resorption and atrophy is uneven, and bone reduction is greatest in facial areas where prominent aging stigmata appear [4,25,31,42,50]. The maxilla has the greatest resorption; substantial reduction in its anterior projection largely contributes to aged appearance. The periorbital bones and anterior and inferior mandible (prejowl area) resorb extensively; the chin becomes shorter. The posterior and superior mandible undergo bone formation, increasing the mandible angle from 97º in younger skulls to 135º in older skulls. Maxilla and mandible resorption appreciably reduces the facial height. The midface recedes, but the forehead continuously expands.

Local changes in soft tissue and mechanical needs can also induce bone remodeling [50]. Mechano-transduction transforms mechanical energy into electro-chemical signaling to tissues or cells. Through this process, chronic facial muscle tension or overuse contributes to skeletal changes by impacting molecular signaling pathways, which alters bone remodeling patterns [51].

Reduction of anterior projection in the aging facial skeleton occurs immediately beneath the periosteum attached to the bone surface. The periosteum recedes with the bone; ligament origins recede with the periosteum [42].

Facial Fat

Superficial and deep facial fat is highly compartmentalized. Aging significantly alters the volume, structure, and position of facial fat compartments. Typically, deep fat atrophies and superficial fat may be unchanged or hypertrophy. Assessment of the fat depletion pattern is crucial for volumetric restoration. With attention to ligament involvement, the pattern is fairly predictable [8,25,30,41,42,50,52]. It occurs first in the periorbital and malar fat. The most extensive loss of deep fat occurs in the lateral and medial orbital fat and medial cheek fat. Likewise, the most extensive loss of superficial fat occurs with lateral temporal and preauricular fat.

Ligaments

Ligaments confine the fat areas; retaining ligaments anchor and stabilize the skin and facial fascia. With aging, medial ligaments of the center face keep their strength with strong fixation points, but lateral ligaments weaken and lose ability to prevent movement of fat compartments (though they may retain the borders). With loss of lateral fat volume and ligament support, the malar fat moves inferomedially and the superficial nasolabial and superior/inferior jowl fat move medially.

Superficial Musculo-Aponeurotic System and Muscles

The ligaments also transmit the effect of skeleton resorption by strongly connecting the skeleton with the superficial musculo-aponeurotic system. Glabella and masseter muscles can become hypo- or hypertonic. Chronic muscle use in facial expressions can aggravate some features of aging. Atrophy is prominent in masticatory muscles.

Epidermis and Dermis

Aging substantially alters the skin. Dermal collagen content declines by roughly 1% every year starting at around 40 years of age in women and 50 years of age in men. The remaining collagen fibers become disorganized, compact, and fragmented. Elastic fibers decrease in number and diameter. Epidermal thinning, collagen loss, and dermal elastosis contribute to fine rhytids of the aging face. Loss of muscle tone, skin elasticity, and thickness leads to sagging [41,49].

These dermal changes trigger a cascade of secondary events that greatly influence surrounding tissues. Wrinkles and furrows, a main focus of patients seeking cosmetic treatment for aging, develop from a slow, progressive alteration of all facial structures [49]. UV radiation from sun exposure substantially contributes to skin changes in aging.

THE INTEGRATIVE AND AESTHETIC UNITS PERSPECTIVES

The two- and three-dimensional models describe age-related changes within facial tissue layers. However, the integrative and aesthetic units models describe how these changes interact and combine into the cosmetic features of facial aging [4,25,30,41,42,53].

As noted, bone resorption is extensive in orbital and periorbital, malar, submalar, and mandibular areas. Soft tissue loss occurs in periorbital, forehead, glabellar, temporal, malar, perioral, mandibular, and mental areas. Retaining ligaments of fat compartments weaken; facial fat and soft tissue descent forms malar bags, folds, and sagging in nasolabial, jowl, and submental areas.

Increased orbit size and posterior maxillary resorption promote inferior displacement of the malar fat, accentuation of nasolabial folds, a blunted midface, and loss of support for periorbital tissues that contributes to perioral lines. Infraorbital volume loss exposes the inferior border of the orbicularis oculi muscle that helps form a malar crescent over the zygomatic eminence (lateral) and the nasojugal fold (medial); formerly concealed infraorbital fat pads ("palpebral bags") emerge.

Periorbital and perioral skin wrinkling from repeated muscle action progress from dynamic rhytids to static rhytids as the skin changes become permanent. Volume loss, distributional changes, and sagging disrupt the defining arcs and convexities of youth and contribute to the distinct morphology of the aging face.

Youthful Appearance and Aging

Loss of youthful features and development of aging features are frequent cosmetic concerns of patients. Expert plastic surgeons and cosmetic dermatologists are broadly uniform in characterizing youthful features and age-related changes. The following section specifically describes female features; male features will discussed later in the course [4,29,32,49,54,55,56,57,58].

The youthful face has a diffuse, balanced distribution of superficial and deep fat, conferring a smooth, three-dimensional topography delineated by a series of arcs and convexities, without clear distinction between temple, eyelid, and malar areas. On frontal view, the primary arc of the jawline, convexities of the temples, and multiple smaller secondary arcs of the lips are evident. In profile, the definitive features of youth are the lateral cheek projection, extending as an unbroken convex line from the lower eyelid to the cheek (the "ogee" curve).

Youthful features converge on the malar area. Prominent malar eminences are a hallmark of beauty in many cultures, and malar area convexity (roundness) is a defining feature of a youthful face. With aging, the malar fat position over the zygoma and orbital rim diminishes and descends. Ptotic cheek fat, and descent of malar soft tissue, produces sunken cheeks and shadows, leaving behind a cheek concavity accentuated by depletion of malar fullness.

From the front, the jawline appears scalloped; the temporal, buccal, and suborbital areas hollow; and the lips straight and angular. In profile, the primary arc of the cheek is broken, the mandibular arc replaced by a jowl line, and the forehead and brow lose their anterior projection.

Youthful features and age-related changes have agreement, but the extent of cosmetic correction is debated. A multinational panel of cosmetic medicine experts recommended an age-appropriate approach as the criterion standard, with a conservative approach preferable [52].

The Facial Aesthetic Units Perspective

The aesthetic units perspective informs how some visibly apparent aging features develop and directs cosmetic intervention. The surface and subsurface structural changes in skin thickness, composition of subcutaneous tissue, contour of the facial skeleton, and location and integrity of retaining ligaments contribute to variability of bony landmarks, formation of lines and wrinkles, variable skin pigmentation, and overall discontinuity of the facial region, termed "facial aesthetic units" [28].

In younger persons, facial aesthetic units flow together, appearing as a smoothly contoured, single dynamic structure without perceptible division. With aging, the redistribution of facial fat, loss of tissue volume, and retention of ligament borders induce a demarcation of the underlying facial structures. The compartmentalized aesthetic units become distinct as changes within and between distinct aesthetic units collectively contribute to an overall aged facial appearance [4,28].

A strong correlation was found between observer judgment of age and visually obvious separation of facial aesthetic units, suggesting it may serve as a psychophysical cue fundamental to perception of facial aging. This finding also aligns with current practice. Facial rejuvenation can include creation of more homogeneous skin tones, texture, and facial symmetry, and smooth contours between anatomical regions by blending the transition of facial aesthetic units for a harmonious and youthful facial appearance [28].

5. BOTULINUM TOXIN

DISCOVERY AND DEVELOPMENT

Botulinum toxin is derived from neurotoxins produced by Clostridium botulinum, the gram-positive bacillus that causes botulism. Subsequent to the 1897 discovery of C. botulinum as etiologic agent of botulism, seven botulinum toxin serotypes (A, B, C1, D, E, F, and G) with differing pharmacologic properties have been identified. Only serotypes A and B are used clinically, with type A (botulinum toxin-A) the most widely used for both medical and aesthetic indications [59].

During the late 1960s and early 1970s, the clinical value of botulinum toxin became evident in the treatment of strabismus. This was followed by demonstrated benefit in blepharospasm, hemifacial spasm, cervical dystonia, and other disorders of muscle hyperactivity and spasticity. From the first report of botulinum toxin-A injection for a cosmetic indication (glabellar frown lines) in 1992, its use has expanded to become the most requested procedure in aesthetic medicine. One commercial brand of botulinum toxin-A, Botox, has become popularized as the generic reference for all cosmetic botulinum toxin [60,61].

Botulinum toxin-A is the primary form used for cosmetic treatment. While less extensively studied for cosmetic indications, botulinum toxin-B also appears to be effective [59].

MECHANISM OF ACTION

Botulinum toxins block the release of acetylcholine from motor neurons at the neuromuscular junction. By inhibiting acetylcholine neurotransmission between peripheral nerve endings and muscle fibers, botulinum toxin weakens or paralyzes skeletal muscle and, in aesthetic medicine, weakens muscular contraction [10].

Botulinum toxin blocks presynaptic acetylcholine release, causing reduced or diminished muscle contraction. This results in temporary improvement in the appearance of the areas affected by lines and wrinkles, for facial contouring and improving the skin [62]. The inhibitory effect is temporary; recovery of muscular function is often evident by three months, but the cosmetic effect may persist longer [10,33].

AVAILABLE PRODUCTS AND FORMULATIONS

Four botulinum toxin formulations are approved by the FDA for aesthetic use (Table 2). The FDA recommends using specific names (e.g., ONA or ABO, Botox or Dysport), instead of serotypes (e.g., botulinum toxin-A), to prevent confusion between products [59]. Discussion in this course is limited to the five serotype A botulinum toxin products approved for cosmetic use; the off-label use of RIMA will not be explored. Unless a specific product is described, botulinum toxin is used to broadly reference the use of FDA-approved botulinum toxin-A formulations.

Table 2: BOTULINUM TOXIN PRODUCTS AND FORMULATIONS

Name, Serotype

Commercial Product

FDA-Approved Indications

Comments

ONA

type-A

Botox

Botox Cosmetic

Vistabel

Vistabex

Vacuum-dried powder (50 or 100 U/vial)

Glabellar, lateral canthal, and forehead lines

The original, most-studied formulation. Widely used off-label for treating other lines and facial contouring.

ABO

type-A

Dysport (300 or 500 U/vial)

Glabellar lines

First marketed in Europe

INCO

type-A

Bocouture or Xeomin (as lyophilized powder in 50 or 100 U)

Glabellar lines

Newer formulation. Free of complexing proteins. May reduce risks of sensitization and antibody formation.

PRA type-A

Jeuveau (4 U [0.1 mL] IM in each of five sites)

Glabellar lines

Newer formulation. Similar in efficacy to ONA.

RIMA

type-B

Myobloc, in liquid (5,000 U/mL)

No cosmetic indications

Less studied than type-A. Used in off-label facial lines. Distributed in the United States and Canada.

DAXI type-A

Daxxify (as lyophilized powder in 50 or 100 U)

Glabellar lines

New formulation (2022 FDA approval)

ABO = abobotulinumtoxinA, INCO = incobotulinumtoxinA, ONA = onabotulinumtoxinA, PRA = prabotulinumtoxinA, RIMA = rimabotulinumtoxinB, DAXI = daxibotulinumtoxinA, U = units.

Source: [59]

ONA, ABO, PRA, INCO, and DAXI must be reconstituted before using, with sterile, non-preserved saline recommended by their respective makers. In practice, many clinicians reconstitute these products in saline containing benzyl alcohol to reduce injection-site pain [63]. Compelling evidence now suggests that reconstitution using preserved saline dramatically improves patient comfort without compromising efficacy [18].

The formulations (i.e., ONA, INCO, PRA, ABO, and DAXI) are not interchangeable. The products differ in units, chemical properties, biologic activities, weight, and manufacturing process. Production process and conditions such as pH, temperature, formulation, and concentration are crucial; alterations in any can increase the likelihood of formation of inactivated toxoid proteins, which in turn may be immunogenic [62].

Dose conversions are not standardized. Dosing is not interchangeable, and the products and procedures should be selected and prescribed according to individual needs and aims of treatment [62].

CLINICAL USE OF BOTULINUM TOXIN

With aging, decreased skin elasticity and repeated muscle contraction cause hyper-functional facial lines, particularly in the glabellar and periorbital regions. Depressor muscles overpower the levators to result in ptosis of the brow and mid-cheek groove, and patients develop horizontal forehead rhytides, glabellar frown lines, or lateral canthal "crow's feet," indications for botulinum toxin use [64].

Botulinum toxin is also extensively used off-label for brow shaping, eyebrow lifting, opening the aperture of the eye, decreasing mouth frown, defining the jaw line, increasing lip show, decreasing gummy smile, reducing "bar-code" lines around the mouth, eliminating "golf ball" chin, reducing platysma bands, and softening a squared, masculine jaw [65].

Patients treated with botulinum toxin for aesthetic purposes can expect their results to last at least three months, but effects can persist four to five months depending on the area treated, dose, and formulation used. The results may last longer for some patients, especially after repeated treatment [62].

Long-term outcome data support practice trends in decreased dosing and increased botulinum toxin injection intervals. Patients treated for glabellar lines over an average of nine years reported high levels of satisfaction sustained by repeated treatment and greater reductions in their perceived age with increasingly longer treatment durations [6].

While botulinum toxin monotherapy of dynamic rhytides is effective, current practice favors botulinum toxin combined with fillers, lasers, and/or light- or energy-based devices for synergistic effects and superior and more durable improvements [10,33,59].

Dilution of FDA-approved botulinum toxin for off-label intradermal injection is used for reducing surface wrinkling by weakening superficial facial muscle activity but sparing deeper muscle function. This approach is also used for reducing upper face rhytides without affecting brow muscles [64,66].

Safe and effective use of botulinum toxin requires the understanding of anatomy, movement of muscles in isolation and in relation to other muscles, the concept of compensatory strengthening, and observant evaluation of the patient at rest (static) and with normal and exaggerated animation (dynamic). Every patient is unique, and inter-patient differences can be vast [65].

Patient Selection

To help determine botulinum toxin suitability, assess facial muscle function and tone in static and dynamic states looking for signs of stronger contraction (e.g., greater dynamic movement, deeper lines, larger apparent mass during use) [67]. Observing dynamic movement of the skin can help identify areas of stronger or weaker muscle contraction, why certain wrinkles are formed, and which muscles are creating them. The findings assign patients to one of the following categories [67]:

- Kinetic: Regular muscle contraction and wrinkles during active expression, but not at rest. Botulinum toxin very likely effective.

- Hyperkinetic: More excessive muscle contraction. May require more frequent, higher-dose botulinum toxin to achieve the desired effect.

- Hypertonic: Inability to relax specific muscles, visible wrinkles at rest. Some benefits may be possible with botulinum toxin, but adding filler injections may be necessary.

- Deep static lines with loss of skin elasticity: Unsuitable for botulinum toxin injection.

Side Effects and Safety

Compared with dermal fillers, prevention of botulinum toxin adverse effects is more straight-forward [18,33,59,62]. Common acute side effects include transient swelling, bruising, and headache. Ice or cooling is commonly used for post-injection comfort and to prevent bruising. Temperature seems to influence botulinum toxin uptake, suggesting that cooling the area might undermine efficacy.

Poor treatment response can result from insufficient or incorrect dosing, anatomical variation, or errors in drug handling during preparation, storage, or administration. Diffusion of toxin to untargeted areas from improper injection placement can result in excessive muscle weakness, cosmetic disfigurement, and/or functional deficits that persist for months.

Contraindications

Evidence Based Practice Recommendation

The Australasian College of Dermatologists strongly recommends that botulinum toxin-A treatment be avoided during pregnancy and breastfeeding owing to the lack of adequate data on the developmental risk to a human fetus from the use of these agents in pregnant women and evidence of reproductive toxicity in animal studies.

https://onlinelibrary.wiley.com/doi/full/10.1111/ajd.13273

Last Accessed: March 19, 2024

Level of Evidence: Expert Opinion/Consensus Statement

Injection-site infection, known hypersensitivity to any product component, and allergy to cow milk proteins for ABO only are all contraindications to botulinum toxin treatment [59]. Perioral botulinum toxin injections in professional speaker, vocalist, or musician patients require discussion of the potential functional impact from weakened or impaired muscle tone, a possible contraindication.

6. SOFT TISSUE (DERMAL) FILLERS

A variety of injectable soft tissue (dermal) filling agents are available for correction of prominent skin lines, fat atrophy, volume lost, and other contour changes of facial soft tissue (Table 3) [68]. Fillers are classed on different variables that inform appropriate selection and potential complications: biodegradability, longevity in the tissue, and histologic reaction [69,70,71].

Table 3: FDA-APPROVED DERMAL FILLERS AND CLINICAL USE

Product, Year Approved

Approved Indications

Hyaluronic acid: Galderma Labs

Restylanea, 2003

Correction of moderate-to-severe facial rhytides and/or folds

Lip augmentation

Restylane-L, 2012

Restylane Silk, 2014

Lip augmentation

Correction of perioral rhytides

Restylane Lyft, 2015

Correction of moderate-to-severe deep facial rhytides and folds

Restylane Defyne, 2016

Correction of moderate-to-severe facial rhytides and folds with age-related volume loss

Restylane Refyne, 2016

Correction of moderate-to-severe facial rhytides and folds

Restylane Kysse, 2020

Lip augmentation

Correction of perioral rhytides

Restylane Contour, 2021

Cheek augmentation, correction of midface contour deficiencies

Correction of perioral rhytides

Hyaluronic acid: Allergan

Juvéderm XC, 2006

Correction of moderate-to-severe facial rhytides and folds

Juvéderm Ultra XC, 2006

Juvéderm Ultra Plus XC, 2006

Juvéderm Ultra Plus XC, 2015

Lip augmentation

Correction of perioral rhytides

Juvéderm Voluma XC, 2013

Correction of age-related volume deficit in the midface

Cheek augmentation

Juvéderm Volbella XC, 2016

Lip augmentation

Correction of perioral rhytides

Juvéderm Vollure XC, 2017

Injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds (e.g., nasolabial folds)

Hyaluronic acid: Merz Aesthetics

Belotero Balance, 2011

Correction of facial rhytides and folds, especially around the nose and mouth

Hyaluronic acid: Teoxane S.A.

RHA 2 and RHA 3, 2017

Injection into the mid-to-deep dermis for correction of moderate-to-severe dynamic facial wrinkles and folds (e.g., nasolabial folds)

RHA 4, 2017

Injection in deep dermis to superficial subcutaneous tissue for correction of moderate-to-severe dynamic facial wrinkles and folds (e.g., nasolabial folds)

Hyaluronic acid: Prollenium Medical Technologies, Inc.

Revanesse Versa, 2018

Injection in mid to deep dermis for correction of moderate-to-severe facial wrinkles and folds (e.g., nasolabial folds)

Calcium hydroxylapatite (CaHA): Merz Aesthetics

Radiessea, 2006

Correction of moderate-to-severe facial rhytides and folds

Radiesse(+), 2015

Poly-L-lactic acid (PLLA): Galderma Labs

Sculptra Aesthetic, 2009

Correction of shallow-to-deep nasolabial fold contour deficiencies and other facial rhytides

Polymethylmethacrylate (PMMA): Suneva Medical

Bellafill, 2006

Correction of volume deficits around the mouth (e.g., nasolabial folds)

Bellafill, 2015

Correction of acne scars

aDoes not contain lidocaine.

Source: [72,73]

The FDA designates fillers as either absorbable/temporary (e.g., hyaluronic acid, calcium hydroxyapatite [CaHA], poly-L-lactic acid [PLLA]) or non-absorbable/permanent (e.g., polymethylmethacrylate [PMMA]) based on the agent's biodegradability. If an agent absorbs within 18 months, it is considered temporary; if it does not absorb within 24 months, it is considered permanent. Some agents combine absorbable material for immediate effect and carrier until a nonabsorbable material induces fibroblast stimulatory effects (in more than 18 months). These agents are considered semipermanent. Agents with minimal tissue response are considered volumizers, while those that induce a strong tissue reaction are considered stimulators.

Temporary fillers use FDA-approved biodegradable materials absorbed by the body over time. Permanent fillers persist indefinitely in tissue. Some FDA-approved fillers, such as collagen-based products or avian-derived hyaluronic acid (Hylaform), remain available but are largely replaced by hyaluronic acid fillers with superior clinical properties and/or negligible allergenic potential [68,73,74].

Most acute side effects and potential serious adverse effects of FDA-approved dermal fillers are common across fillers. All filler agents are contraindicated in patients with known hypersensitivity to any product component specific to the product. There are a variety of other contraindications to the use of various dermal fillers (Table 4).

Table 4: CONTRAINDICATIONS TO DERMAL FILLERS

Contraindication

Specific Conditions

Relative and absolute contraindications

Allergic history

Multiple severe allergies

Anaphylaxis

Heightened immune responses to common inhaled and food allergens (atopy)

Allergy to latex, hyaluronic acid products, streptococcal/other gram-positive bacterial proteins, or lidocaine

Desensitization therapy during filler treatment

Scar-related

History of hypertrophic scarring or keloid formation

Scars at intended treatment site

Bleeding-related

Current anticoagulant or antiplatelet therapy

History of bleeding, clotting (hemophilia), or connective tissue disorders

Active autoimmune disease

Systemic lupus erythematosus

Rheumatoid arthritis

Hashimoto thyroiditis

Patient-related factors

Unattainable expectations

Pregnancy

Lactation

Contraindications unless fully resolved with treatment

Inflammatory skin diseases

Atopic dermatitis

Seborrheic dermatitis

Acne

Rosacea

Psoriasis

Skin infection or any unhealed facial wound

Impetigo

Folliculitis

Propionibacterium acnes

Viral warts

Perioral HPV

Molluscum contagiosa

Streptococci or staphylococci bacterial infections

Candida (yeast) infections

Local infection

ENT, oral cavity, or dental infections or abscess

Remote infection

Intestinal tract, urinary tract, or bladder infection

Inflammatory processes

Pimples

Hives

Rashes

Cysts

ENT = ear, nose, or throat, HPV = human papillomavirus.

Source: [19,75]

With all fillers, treatment should undercorrect the defect and avoid overcorrection. All treatment sites should be massaged immediately after injection to facilitate an even distribution.

HYALURONIC ACID

Hyaluronic acid is a glycosaminoglycan disaccharide and natural constituent of the dermal extracellular matrix, cartilage, and connective tissue. Hyaluronic acid is highly hydrophilic, enabling dermal hyaluronic acid to hydrate and cushion the skin and fill empty spaces within the extracellular matrix. Dermal hyaluronic acid content declines with skin aging, which reduces water-binding capacity and elasticity, induces volume loss, and promotes the development of rhytids and other aging features [72,73,76,77].

Unmodified hyaluronic acid readily dissolves in water to form a viscous gel, but injected into the dermis, it is quickly degraded by hyaluronidase and free radicals in the skin [76]. Most FDA-approved hyaluronic acid fillers use nonanimal stabilized hyaluronic acid synthesized from Streptococcus equi bacteria. Liquid nonanimal stabilized hyaluronic acid, as with native hyaluronic acid, is rapidly broken down [72,77]. To increase stability and longevity, manufacturers use crosslinking agents to bind hyaluronic acid polymer chains to each other, resulting in a gel that resists enzymatic and free radical breakdown. Most fillers use 1,4-butanediol diglycidyl ether (BDDE) as a cross-linker [76,77]. The hyaluronic acid modification process, proprietary to each maker, allows a portfolio of hyaluronic acid filler consistencies with varied rheologic properties (e.g., viscosity, gel hardness, lifting ability, tissue integration) that determine optimal tissue placement depth and product longevity [19,78,79].

Hyaluronic acid can bind 1,000 times its volume in water. This water-binding and space-filling effect underlies the volumizing efficacy of hyaluronic acid fillers [76]. Efficacy has been observed to persist beyond a time frame explained by space-filling effects alone. This led to research of other mechanisms, which identified induction of adipogenesis, neocollagenesis through mechanical tension on fibroblasts, and periosteal stem cell activation followed by new tissue formation with periosteal filler placement [52,80,81].

Hyaluronic acid fillers combined with botulinum toxin act synergistically to produce superior, more durable effects than either monotherapy. For example, the longevity of effects is improved when treating sites of dynamic wrinkles, such as glabellar lines. Reduced filler deformation due to botulinum-toxin induced local muscle relaxation at least partially accounts for this effect [68].

CALCIUM HYDROXYLAPATITE

Calcium hydroxylapatite (CaHA) is a mineral commonly found in human teeth and bones that functions as a scaffold for collagen ingrowth. CaHA filler contains CaHA microspheres as biodegradable particles suspended in an aqueous carboxymethylcellulose gel carrier. Once injected, the carrier gel gradually resorbs; the microspheres stimulate a fibroblastic response resulting in active physiologic remodeling of the extracellular matrix and long-term collagen deposition around the implant that promotes volumizing. The microspheres eventually degrade into calcium and phosphate ions and are excreted. The effects last around 18 months [10,73,79].

Radiesse (formerly Radiance) is the only FDA-approved CaHA filler, indicated for correcting moderate-to-severe soft-tissue defects, facial folds, and wrinkles, including nasolabial folds [72]. The viscoelastic filler is well suited for supraperiosteal and deep fat placement. When injected more superficially, it should be diluted 1:1 or 1:2 [10,68]. Radiesse(+), formulated with 0.3% lidocaine, was approved in 2015 to reduce pain without needing to premix before injection [82].

Radiesse is contraindicated in patients with a history of anaphylaxis or multiple severe allergies [68]. Radiesse injection of the lips risks forming nodules and should be avoided. Radiesse is visible on x-ray and may obscure underlying features [73].

POLY-L-LACTIC ACID

Poly-L-lactic acid (PLLA) is a biodegradable, biocompatible, synthetic polymer used for decades in resorbable sutures, orthopedic plates, and urologic stents. First approved in 1999 as a dermal filler in Europe, PLLA received FDA approval in 2004 for the treatment of HIV-associated lipoatrophy (Sculptra) and in 2009 for aesthetic treatment in immunocompetent patients (Sculptra Aesthetic) [49,72,73].

PLLA induces a subclinical inflammatory response that stimulates fibroblast proliferation, neocollagenesis, and type I collagen formation, leading to a progressive increase in dermal volume [68,72]. Each PLLA injection produces a gradual treatment effect with limited correction. Three injection sessions at six-week intervals are generally required, but improvements after the final injection can last up to two years. Patients should be counseled that final results can take months to achieve [83,84].

Treatment should aim to undercorrect, because the results progressively improve over time. Injections should be spaced at least three weeks apart because transient post-injection edema can mimic a full correction [68].

Injections should be placed into the deep dermis or subcutaneous fat. The lip and periorbital region should be avoided due to risk for nodule formation. Subcutaneous papules are a common adverse effect [68].

POLYMETHYLMETHACRYLATE MICROSPHERES

Polymethylmethacrylate (PMMA) is a non-biodegradable, biocompatible, synthetic polymer used in medical devices such as bone cement and intraocular lenses. As a soft tissue filler, PMMA microspheres are tiny, round, smooth particles suspended in a gel-like solution containing lidocaine and bovine collagen [73].

The collagen gel gives an initial volume but is resorbed over one to three months. The microspheres stimulate a local inflammatory reaction, followed by deposition of granulation tissue that encapsulate the microspheres and mature into connective tissue. By three months post-injection, the microspheres are surrounded by newly formed collagen, accounting for the observed volume-filling effect [74,79,84]. Tissue encapsulation of PMMA microspheres makes the results irreversible.

The PMMA filler Bellafill is the only FDA-approved permanent filler. Treatment of nasolabial folds and facial acne scars are the only approved cosmetic indications, but Bellafill is used off-label to volumize other mid- and lower-face contour defects [74,85].

The bovine collagen carries potential immunogenic issues. Clearance for Bellafill injection requires non-reactive response to skin-testing for bovine collagen hypersensitivity one month pre-procedure [74,79].

Good PMMA candidates are patients with well-defined lines and furrows and minimal excess skin [74,85]. PMMA use is not recommended in areas of thin skin (e.g., lower eyelid, neck), the lips, and in patients with generally thin, loose skin [74].

Bellafill is intended for deep tissue placement. A series of conservative injections can be required for optimal results, with touch-up injections performed one to three months after initial treatment [74]. Optimal results require 3 to 12 months for sufficient new collagen synthesis, and additional improvement beyond 12 months may occur [86].

FILLER SELECTION

Hyaluronic Acid Fillers

Unlike CaHA (Radiesse), PLLA (Sculptra), and PMMA (Bellafill) fillers, availability of numerous hyaluronic acid products requires judicious product selection based on rheologic properties. Each facial area and anatomic plane subjects filler to biomechanical stressors of compression, stretching, and lateral shearing from skin tension, muscle activity, and fat volume of varying intensity and frequency [78,87].

Rheology studies the flow and deformation of filler material subjected to biomechanical stressors to understand their clinical properties and behavior. Manufacturers crosslink and modify hyaluronic acid products (e.g., Hylacross, Vycross) using methods that determine gel rheology. The rheologic properties leverage the distinct tissue distribution patterns and clinical behaviors of hyaluronic acid products [76,77].

The clinical behavior of Radiesse is influenced by the same rheologic factors as hyaluronic acid fillers. Rheologic properties are unique to each hyaluronic acid and CaHA product, between filler families. The major rheologic properties are [9,29,53,76,78,88,89,90]:

- Shearing: Force pushing one part of a body in one direction and another part in the opposite direction

- Elasticity: Ability to resist deformation by external forces

- Viscosity: Ability to resist shearing forces

- Cohesivity: Ability to resist vertical compression and stretching

- Hydrophilicity (water-binding ability): Capacity to attract water and expand

- Particle size: Contributes to overall lifting and filling power

- Particle concentration and crosslinking: Influences durability by resisting enzymatic degradation.

Clinically, the elasticity of filler reflects the gel's firmness. The level of viscosity will determine the pattern and extent of tissue integration. High-viscosity agents resist tissue spread and shearing. Low-viscosity agents are ideal for superficial placement to treat shallow folds and lines and are best used where spread and softness is more important than volume (e.g., the lips) [53,76,77,78]. Conversely, high-elasticity and high-viscosity gels are best suited for deep placement to treat deep folds and restore volume loss by creating volume and lift in the mid- and lower face.

Cohesivity is spreading related to tissue depth and ability to hold form or shape under stress by overlying/underlying muscle and skin compression. Cohesivity increases with degree of cross-linking and hyaluronic acid concentration. Low-cohesivity gels are easier to mold and spread evenly in the skin, making them suited for correcting small rhytides. High-cohesivity gels are suited for revolumizing large areas of volume loss.

Restylane Lyft is an example of a high-elasticity, large-particle gel with greater filling power and resistance to degradation in deep-tissue volumizing. Juvéderm products use elasticity from highest to lowest in gels intended for deep (Voluma), midlevel (Vollure), and superficial (Volbella) tissue placement.

Calcium Hydroxylapatite

With a high lift capacity and results that last more than one year, Radiesse works well to fill volume loss in the midface and is placed in a manner similar to injection of hyaluronic acid products [84]. The use of Radiesse for melomental folds ("marionette lines") has been reported extensively, with effective and durable results [58].

Of note, Radiesse may be more likely than other fillers to result in intra-arterial complications, skin necrosis, and blindness. The increased propensity to cause vascular compromise could be related to particle size, with larger particles resulting in more proximal vessel obstruction. Certain particles may also stimulate the clotting cascade, ultimately resulting in skin necrosis [16]. This seems to elevate precautions in using this product near vascular danger zones.

Poly-L-Lactic Acid (Sculptra)

PLLA volumizes soft tissue in a gradual, progressive, and predictable manner, providing natural-looking restoration of facial volume [91]. Although it is categorized as biodegradable by the FDA, the duration of action is 12 to 24 months and, with repeat treatment, several years. As noted, PLLA is more accurately classed as a semipermanent dermal filler [84,92].

PLLA should be avoided in perioral and periocular areas; in the neck where thin skin requires superficial injection; and in mandibular ligament/platysma muscles [49,58]. Superficial injection in the dermis is also inappropriate. PLAA injection is recommended for the supraperiosteal in the temples, lateral brow, zygomatic area, maxillary area, mandibular area, and mental area [93]. It may also be used in the subcutaneous fat in the mid-cheek regions and preauricular area. More specifically, recommended PLLA injection sites are [49,58,93]:

- Temporal fossa: Supraperiosteal at the temporal muscle origin

- Lateral brow: Supraperiosteal at the tail of the brow

- Medial malar region: Supraperiosteal on the zygomatic bone, maxilla, and pyriform fossa

- Submalar/mid-cheek: Deep subcutaneous plane where bony background is absent

- Lateral third of the mandible/mandibular angle and lower lateral cheek: Superficial subcutaneous fat above the parotid gland and masseter muscle

- Mandible/chin: Supraperiosteal over the menton and prejowl sulcus

Sculptra may provide global volume restoration in lean patients who are too depleted for space-occupying fillers, an alternative to deep volumizing hyaluronic acid fillers that could be too expensive and difficult to use as scaffolding [94].

Polymethylmethacrylate (Bellafill)

Used as a deep tissue filler for mid- and lower-face volume loss, Bellafill seems comparable to other filler types in efficacy [84]. This shifts the basis for Bellafill selection to patient preference and appropriateness [34,74].

Persistent effects, possibly with a single treatment (or with minor touch-ups), can make Bellafill attractive, but treatment with permanent fillers requires careful screening. Patients who have histories of unsubstantiated dissatisfaction with cosmetic results, are unsure of their desired outcome, or are new to fillers are poor candidates for Bellafill [34,74].

Other Considerations in Filler Selection

Clinician experience influences the choice of filler. Improper use can result in an unacceptably high risk for adverse effects, and clinicians not trained in using specific fillers should refrain from their use [34,74]. Complications or unfavorable cosmetic results with permanent fillers may require surgical intervention and may be impossible to completely reverse.

The desired duration of effect should be considered. Fillers that eventually degrade in tissue (e.g., hyaluronic acid) offer the advantage of reversibility but require multiple subsequent treatments to maintain the desired effect. Adverse effects of products may not become apparent until post-market, making it prudent to select products with an established safety/adverse event profile from clinical use [95].

7. DEOXYCHOLIC ACID

Deoxycholic acid (Kybella) is FDA-approved for treatment of moderate-to-severe submental fullness/convexity ("double chin"). Injection into the subcutaneous fat below the chin area causes focal adipolysis and necrosis. This induces macrophages to clear cell membrane fragments, recruit fibroblasts, and stimulate neocollagenesis. Once destroyed, adipocytes cannot store or accumulate fat. Submental appearance is improved through subcutaneous fat reduction and tissue tightening [96,97].

Kybella is an alternative to liposuction for achieving an aesthetically pleasing jawline by submental fat reduction, but comparisons in clinical trials are lacking. Kybella is given in 0.2-mL injections, spaced 1 cm apart, until all sites in the planned treatment area are injected. Up to 50 injections, or 10 mL, are allowed per session. Several sessions spaced at least four weeks apart are usually required. In phase 3 clinical trials, the drug was effective and safe, although a significant number of patients experienced pain, transient bruising, edema, and numbness [98,99].

In the phase 3 trials, patients were injected with a mean 186 mg of drug as treatment. Cosmetic surgeons reported charging a mean $691 per 20-mg vial of deoxycholic acid, which would have cost the average study participant $6,426.35. In contrast, the average patient cost for submental liposuction is $2,976.56. While Kybella is cost-effective only for patients with mild-to-moderate submental liposis who require fewer injections and treatments, the avoidance of surgery for some patients may outweigh the greater expense [99].

With a 13% decrease in procedures performed in 2020 (135,586) compared with 2019 (156,153), Kybella uptake into cosmetic practice seems limited following its 2015 FDA approval [12].

8. INDIVIDUALIZED ASSESSMENT AND TREATMENT PLANNING

KEY ASSESSMENT ELEMENTS

Optimal assessment of facial aging begins with a thorough patient history and examination that assesses anatomical structure and age-related changes to the bone, fat, muscle, and skin. Specifically, this should include [10,49]:

- Skeletal changes

- Degree and location of volume loss

- Muscle anatomy and movement

- Appearance of lines and wrinkles

- Skin quality

- General facial appearance, symmetry, or any imbalance in facial proportions

The use of photonumeric scales are recommended for the objective assessment of facial aging features. Photonumeric scales have the advantage of providing a consistent visual frame of reference that minimizes variability in perception and subjectivity [100].

With these scales, assessment of the upper, mid, and lower face is performed, with specific aging features rated using a 0–4 scale (0: absent; 4: advanced) [101,102,103]. The score helps inform the appropriate level of intervention [10]:

- Early intervention: Individuals with minimal evidence of facial aging (Levels 0–1)

- Restoration: Individuals with moderate to advanced signs of aging (Levels 2–4)

The assessment lays the foundation for a detailed, individualized treatment plan that balances clinical experience with patient desires and expectations [10]. In this initial period, it is important to discuss treatment goals and ensure the patient understands the progressive nature of the aging process. Costs should also be reviewed, and in patients with limited financial means, treatment should focus on areas that will have the greatest impact. When the individualized treatment plan is formulated, the extent and sequence of procedures and/or treatments should be discussed. Clinicians should ensure the patient understands the maintenance involved in any type of facial restoration and that overtreatment and unnatural results (and likewise undertreatment and suboptimal results) will be avoided.

ETHNIC CONSIDERATIONS

Fundamental to individualized patient assessment is careful consideration of racial/ethnic and gender variation in facial aging features. In this course, the terms used to reference ancestry are Caucasian (European, North African, southwest Asian/Middle Eastern), African (sub-Saharan Africa), Latino/Hispanic (Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture), East Asian (China, Korea, Japan), Southeast Asian (Thailand, Singapore, Indonesia), and South Asian (the Indian subcontinent) [104].

People of all races have distinct ethnic features, yet cultural standards of beauty share remarkable similarity around the world, such as balance, proportion, and symmetry of facial features, and clear, unblemished, and youthful skin [105,106].

The aging process may manifest differently among various ethnic/racial group; aging promotes and accentuates intrinsic differences of facial morphology and structure. This leads to variations in aged features, such as "Caucasian corners" of lips that develop into marionette lines [94,105].

Relative to other ethnic/racial groups, the earlier onset and more extensive facial aging common in Caucasian patients reflects the interaction of morphologic features and skin quality. Bony remodeling, facial fat and soft tissue volume loss, deflation, and descent give rise to the same common signs of aging in all ethnic groups, making restoration of volume and correction of related sequelae fundamental strategies for every patient [53,105].

Skin Phototype

A powerful determinant of skin aging is the amount of melanin pigment in skin, which determines skin color or phototype. The Fitzpatrick Scale is a classification system that assigns individuals to one of six distinct phototypes based on skin complexion and response to UV radiation exposure (Table 5) [35,107]. Phototype is more tied to the equatorial proximity of one's ancestors than to specific ethnicity.

Table 5: FITZPATRICK SKIN PHOTOTYPES

Phototype

Unexposed Skin Color

Sun Exposure Responsea

Examples

I

Pale white

Always burns, never tans

Red hair with freckles

II

White

Burns easily, minimal tan

Fair-haired Caucasian, Northeast Asian

III

Olive to light brown

Burns minimally, gradually tans

Mediterranean Caucasian, East Asians

IV

Moderate brown

Burns minimally, tans well

Some Southwest Asian (Middle East) Caucasian, South Asian, Hispanic

V

Dark brown

Rarely burns, tans profusely

Darker Hispanic, some African

VI

Deeply pigmented dark brown to black

Never burns, tans deeply

Darker African, Indigenous Australian

aAfter one hour on sun-shielded, untanned skin.

Source: [107,108,109]

Variations in Aging Features

In phototypes IV–VI, the thicker, more compact dermis and higher melanin content delays the onset of skin aging, skin laxity, and sagging. In these individuals, aged skin presents with muscular or expressive lines instead of early fine wrinkling [10].

Craniofacial measurements of diverse racial/ethnic groups were originally compiled for reconstructive surgeons, who required normative data in treating congenital or post-traumatic facial disfigurements. These data inform cosmetic practice in diverse patients who age differently [110,111]. Unless otherwise stated, Caucasian facial characteristics are the point of reference for ethnic/racial variations discussed in the following sections [104]. This is the literature standard and should be taken as a guide rather than a determinate of beauty or value.

African

Compared with White individuals, persons of African descent have skin that maintains its structural integrity and youthful appearance. This bestows lower rates of facial rhytides, brow ptosis, lip aging, lip volume loss, and perioral rhytides formation [104,111].

Facial aging tends to show more prominently in the periorbital region and midface. Patients with African ancestry can exhibit pronounced sagging of the malar fat pads, soft-tissue laxity, and jowl formation of the midface. Unlike the laxity and descent of Caucasian skin, the thickness and weight of skin contribute to jowling in these patients [104].

Aging Black patients often have fewer issues requiring soft-tissue augmentation but may seek to restore the youthful fullness of their lips. Typically the upper lip alone is treated, as the lower lip usually maintains its volume [111].

Latino/Hispanic

This heterogeneous group encompasses individuals with any combination of White, Native American, and/or African-American features. For patients with predominately Native American characteristics, approaches for East Asians are recommended; when Caucasian characteristics predominate, approaches appropriate for this group are used [111].

Patients of Mexican or Central or South American origin tend to have rounder faces with heavy eyelids, a prominent malar eminence and midface area, broader nose, abbreviated nasal length, and a recessed chin. With aging, the mid-cheek area becomes thicker and heavier, with fat pad accumulation and more prominent nasolabial folds, along with eyebrow and eyelid drooping and lower lid fat accumulation [104].

East Asian

East Asians tend to have a wider face with wider bitemporal and bizygomatic width, shorter in vertical height, lower structural projection of the midface, and lack of brow, nasal, and chin projection. Aging is likely to present as central face retrusion; flattening of the anteromedial midface; recessed piriform fossa; and a flatter forehead. A flatter facial skeletal framework promotes greater soft-tissue descent of the midface, malar fat pad ptosis, and tear trough formation [53,105].

These features account for the prevalence of fillers of the medial midface, nose, chin, and forehead of younger Asian patients. In older patients, these regions are a priority, along with correcting age-related disharmonies. Volumizing is limited to the medial maxilla area to enhance central projection and to avoid further widening the midface. Lip augmentation is usually not needed, especially in patients of Southeast Asian origin who present greater lip fullness and may more likely desire lip reduction to balance the lower third of the face [53,104,111].

South Asian

South-Asian populations differ from Caucasian and East Asians, with smaller width of the malar prominences, smaller mandibular width and height, a much shorter lower third of the face compared with the middle and upper thirds, and smaller facial skeletal width compared with Caucasians. The downward medial descent of soft tissue is more aggressive due to higher volumes of facial fat pad over a smaller bone framework [56].

Bony changes and loss of lateral temple and cheek fat are best approached by volumizing the anterior mid-cheek and nasolabial fat pads, avoiding the deep medial midface fat pads. Nasolabial and medial midface correction should be very conservative, with emphasis on deep fat volumizer placement in lateral zones [56].

A concern of some patients is of repeated filler treatment producing an overtreated appearance and unsatisfying outcome. To address this concern, avoid volumizing the medial midface where soft tissue descent aggregates, compensating for this pattern by focusing on lateral midface volumizing [56].

GENDER CONSIDERATIONS

Men represent a small but growing proportion of cosmetic patients and distinctly differ from women in facial anatomy, physiology, and aging. Knowledge of sexual dimorphism (phenotypic differences between sexes) of the entire facial form, including the skeletal structure, musculature, vasculature, soft tissue, and skin is vital for aesthetic outcomes. Female facial characteristics remain the frame of reference for male variations [50,112,113,114,115].

Sexual dimorphism of skull characteristics is foundational to gender differences in facial features (Table 6). The facial vasculature of men is greater in density. Men have increased facial muscle mass, including the mimetic muscles, greater facial muscle movement, and greater upward vertical movement capacity in facial expressions (e.g., smiling, puckering of lips). Unlike the more curvilinear cheekbone in women, the male midface is more angled due to strong muscle insertions. Facial movement contributes to rhytid formation. Men have greater severity and distribution of facial rhytides; the perioral area is the only exception.

Table 6: SEXUAL DIMORPHISM OF THE SKULL

Area of the Face

Female

Male

Forehead

More straight

More oblique

Glabella

Curved and subtle

Frontonasal suture is more prominent

Supraorbital rim

Less conspicuous

More striking

Midface

Subtle angles

Irregular surface and little anterior projection

Zygoma

More prominent and curvilinear

Less prominent

Mandible

Lighter, with subtle angles

Larger, stronger, with clear-cut angles

Chin

Smaller and rounded shape

Larger and square-shaped

Source: [50]

Facial subcutaneous fat exhibits sexual dimorphism. The subcutaneous fat is 1.5 times thicker in the medial malar fat compartment of women, but the distribution is uniform in men. Men have less soft tissue in the cheek area overall, and the subcutaneous fat layer is thinner in men regardless of age.

The loss of subcutaneous fat, thicker skin, and more prominent facial musculature results in deeper expression lines and contributes to the greater severity of male rhytides. The prominent volume loss makes men appear older than their age, relative to women. Aging also causes a more significant downward shift of the lower eyelid in men.

Treatment Considerations

Understanding sexual dimorphism is crucial to prevent unwanted feminization of male features, a primary concern of male patients seeking aesthetic treatment [53,114,116,117]. In addition, cosmetic intervention that produces an exaggeration, rather than restoration, of typical male features can result in an aggressive or threatening appearance [115]. Of course, some men do wish to attain a more feminine or masculine appearance, but this is beyond the scope of this course, which focuses on cosmetic procedures to address unwanted facial changes associated with aging.

General approaches to minimally invasive correction of cosmetic concerns in older men vary by the area of the face [53,113,114,116,117].

Upper Face

Overfilling the temple should be avoided, because temporal hollowing is aesthetically appealing in many men. With botulinum toxin for rhytides, the lateral frontalis muscle is injected to prevent lateral brow arching and to maintain the flat male brow position. The frontalis may require more injections due to the larger forehead area. In a brow already lower with age, inferior frontalis injection requires caution to avoid ptosis (when brow position falls below the orbital rim) [53,113,114,116,117].

Midface

In the subcutaneous medial cheek fat compartment, uniform injection of filler replaces volume loss while maintaining a flatter and more angular cheek contour. The structural support may also improve the tear trough and palpebral malar groove. Fillers should be injected laterally along the zygomatic arch, avoiding a feminizing convexity from overvolumizing the anterior and medial cheeks [53,113,114,116,117].

Lower Face

Filler injections can restore or enhance the projection of the chin; increasing its forward projection helps tighten the jawline area, and increasing its lateral borders helps to square a recessed chin and add definition to the jawline. To restore volume or enhance shape, the supraperiosteal temporal-buccal fat pad is injected, which will project the jaw laterally and strengthen the jawline if a more square jaw is desired [53,113,114,116,117].

AGE CONSIDERATIONS

Aesthetic medicine professionals are confronted by increasing demand for cosmetic treatments by young patients. Treating this age group can be difficult to justify, but standard physiologic aging and individual concerns can guide age-appropriate cosmetic counseling, prevention, and intervention [118].

In patients younger than 20 years of age, minimally invasive cosmetic procedures are generally inappropriate. Emphasis is placed on prevention counseling (e.g., protection against sun damage) and addressing age-independent congenital characteristics or acquired disharmonies (e.g., acne scars) [53,118]. Cumulative exposures to UV radiation, smoking, and pollution can initiate early collagen decline, leading to noticeable fine lines and wrinkles in some patients in their 20s. Appropriate treatment includes noninvasive modalities or botulinum toxin, which is FDA-approved for rhytides in patients 18 years of age and older [118,119].

The typical age of patients who seek cosmetic procedures is between 30 and 50 years. When clinically indicated, fillers and toxin can demonstrably benefit older and younger patients. Patients between 30 and 50 years of age often achieve the most benefit from botulinum toxin treatment; a greater proportion of rhytides in older patients may be due to loss of skin elasticity, which is not alleviated by botulinum toxin [33]. There is no upper limit for age beyond which benefits cease, assuming that dose and injection sites are tailored to muscle mass and function [53].

9. THE MINIMALLY INVASIVE TREATMENT APPROACH

In the recommended practice of minimally invasive therapy for aging features, discussion begins with an overview of evidence that informs practice and the sequence of treatment delivery. Next, for each horizontal zone, the clinical features of aging are briefly reviewed and corresponding interventions are described.

The practice standard for facial aging is volume replacement, tissue tightening, and skin rejuvenation (resurfacing). Therapies for skin resurfacing include lasers/light (e.g., intense pulsed light, fractional laser), energy (e.g., microfocused ultrasound with visualization, radiofrequency) and topical (e.g., microdermabrasion, chemical peels) modalities. These mostly noninvasive therapies are mentioned by necessity as recommended components of multimodal treatment, but specifics of their use are beyond the scope of this course.

RECOMMENDED THERAPY COMBINATIONS

Improved understanding of facial aging and mechanisms of therapies inform their combination and sequence of use. With superior outcomes repeatedly demonstrated with combination therapy over monotherapy, this approach is now recommended for most patients [6,10,33,34,53,120].

Botulinum Toxin Plus Hyaluronic Acid Fillers

Botulinum toxin and hyaluronic acid fillers act synergistically for superior improvements and duration [34,53,79,87,120]. Recognition that hyperdynamic muscle activity leads to both soft tissue volume loss and rhytides has prompted botulinum toxin injection one to two weeks before fillers. Botulinum toxin increases filler efficacy by diminishing the dynamic muscle component of the target, and improves longevity by preventing filler breakdown from repetitive muscle activity. Fillers can extend botulinum toxin efficacy to six months.

Botulinum toxin is less effective in deep lines and creases (e.g., glabellar or forehead rhytides), and repetitive muscle contraction degrades filler efficacy to soften the appearance. Botulinum toxin/fillers overcome the respective monotherapy limitations to produce superior extent and duration of improvement, without increased bothersome or significant side effects. Outcomes are optimized by treating aesthetic units.

Botulinum Toxin/Hyaluronic Acid Fillers Plus Lasers/Light Therapies

Combined with energy-based therapies, the efficacy of botulinum toxin/fillers is superior to monotherapy, without increased spread of botulinum toxin, filler migration, or other untoward effects [10,94]. Botulinum toxin before laser resurfacing improves post-laser healing, collagen remodeling, and aesthetic results, while post-laser botulinum toxin reduces wrinkle recurrence, prolonging resurfacing efficacy.

Botulinum toxin added to intense pulsed-light treatment of photoaging increases overall aesthetic benefits. Microfocused ultrasound and radiofrequency stimulate fibroblast proliferation and new collagen for efficacy in cutaneous sagging, wrinkling, and marionette lines. Outcomes are usually more satisfactory combined with hyaluronic acid fillers.

RECOMMENDED THERAPY SEQUENCE

Ideally, all treatments should be spaced apart at least two weeks, with botulinum toxin given two weeks before filler injections in areas of static lines, dynamic rhytides, or deep folds. However, patients may prefer same-day botulinum toxin and filler injection for convenience. This is thought to be safe, with botulinum toxin injection before fillers to avoid toxin spread beyond the treated area [8,10,11,29,30,53,71]. In the four weeks before and after filler injection, lasers, intense pulsed light, chemical peels, microdermabrasion, and over-the-counter or prescription wrinkle treatments should be avoided. It is also important to avoid concurrent botulinum toxin with laser resurfacing or microfocused ultrasound; increased blood flow and edema may promote toxin diffusion and side effect risks.

The midface is treated first. Patients with nasolabial fold complaints may require education that correcting midface volume naturally and effectively treats overall aging features. The filler injection sequence is lateral, then middle, then medial fat compartments; in some cases, a sequence from deep to superficial tissue planes is suitable. New filler injection over previous fillers ("layering") is discouraged due to greater risk of potentially serious complications [8,10,11,29,30,53,71].

PATIENT-TAILORED TREATMENT

While minimally invasive procedures can improve facial texture and volumize, reduce, contour, lift, or reinforce soft tissue, optimal safety and aesthetic outcomes require individualized treatment planning based on assessment of skin changes, tissue quality, extent and pattern of muscle contraction, and soft/hard tissue volume loss [2,53]. These principles become obscured when rigid adherence to algorithms or cutaneous landmarks (which shift with age) supersedes a patient-tailored approach [53].

Declining tissue quality and skin laxity are indications for combining fillers with lasers or energy-based devices. In older patients, fewer injection sites and smaller toxin doses at each site may be indicated if muscle mass or function is reduced [53].

THE TRI-VECTOR TECHNIQUE

Patients present with varying levels of lipoatrophy regardless of age, and the tri-vector technique adapts practice standards into an easily patient-tailored framework [121]. In each horizontal zone, this approach initiates filler injections in lateral compartments, working from lateral to medial.

In this approach, step one is supra-periosteal filler injections. In the upper face, injections are made in the temporal fossa to address forehead atrophy, brow ptosis, and temporal volume loss. Filler in the midface addresses volume loss of preauricular (in front of ear) lateral cheek and mid-cheek fat, tear trough, and infra-nasal lines/folds; in the jawline, injections can address mandibular angle changes and maxilla and mandibular fat volume loss (also marionette lines).

The second step consists of deep dermis filler injections at three ligament support sites to provide fibrous fixation points and restrain facial skin against gravitational changes. These sites are:

- McGregor patch (posterior to zygomaticus minor muscle)

- Pyriform aperture (superior part of nasolabial fold)

- Modiolus (lateral to inferior part of nasolabial fold)

The final step in this approach is patient-specific. It may include filler injection in dermal or superficial fat layers to contour the face, soften any sharp angles (especially in jawline area), or address focal superficial lipoatrophy sites [121].

THE UPPER FACE

In each horizontal facial zone, there are compartmentalized anatomic regions that undergo changes and/or loss of volume and tissue integrity with age. Differences in underlying bony structure, weight, and soft-tissue quality influence inter-patient variations in specific aging changes [29,49].

The youthful upper face is characterized by a subtle convexity of the temple, forehead, and lateral brow and upper eyelid fullness [29]. The aged forehead skin, with loss of bone and fat support, is pulled by repetitive activity of depressor muscles and mimetic musculature to form horizontal rhytides. With temporal and forehead volume loss, glabellar rhytides deepen and lateral canthal rhytides (crow's feet) develop at rest and at smile [10].

The eyebrows, a powerful and versatile facial feature, greatly contribute to the perception of facial attractiveness, and fundamentally inform sexual dimorphism, facial recognition, and nonverbal communication [122]. Low medial brows, even without furrowed wrinkles, signal hostility and anger [65]. Brow ptosis develops as periorbital bone remodeling and temporal deep fat loss erode the support and fullness of the upper lid, causing the brow to descend to the superior orbital rim [4,29]. Fixed glabellar frown lines, transverse forehead furrows, temporal hollowing, skeletonized supraorbital rim, brow ptosis, and redundant upper eyelid skin combine to form an aged appearance to the upper face [4,29].

The forehead, glabella, and temples are treated as one aesthetic unit, with botulinum toxin for muscle modulation, fillers to improve temporal hollowing and contours of the forehead, and microfocused ultrasound to lift the ptotic brow and tighten the skin [10,11]. This "aesthetic unit" principle is underscored by inter-relationships of the brow elevator (frontalis) and depressor (corrugator, procerus, orbicularis oculi) muscles. With antagonistic function, botulinum toxin injection in one muscle causes unopposed strength in another [11,79].

Botulinum Toxin Treatment

Lines, furrows, and creases develop over time from hyperactive, repetitive use and contraction of various muscles. Botulinum toxin injection into culpable muscles can smooth vertical glabellar rhytides (glabellar complex muscles), horizontal forehead rhytides (frontalis muscle), and periorbital lateral canthal rhytides (lateral orbicularis oculi muscle) [33].

Horizontal Forehead Rhytides

The frontalis, the sole elevator muscle in the upper face, contracts to raise the eyebrows and upper eyelid to express surprise or fright. Frontalis contraction eventually forms horizontal forehead rhytides [33,67].

Horizontal forehead rhytides require simultaneous botulinum toxin injections of the frontalis and brow depressors. With frontalis muscle injection alone, unopposed activity of depressor muscles will induce a lowered, angry-looking brow ptosis. Frontalis injections are 2–3 cm above the brows; closer brow placement risks inhibition of facial expression and brow ptosis [11,33].

Glabellar Rhytides

Treatment of glabellar frown lines is an integral part of harmonizing the brow shape and eyebrow position. Glabellar lines are caused by contraction of the corrugator and orbicularis oculi muscles (move the brow medially) and the procerus and depressor supercilii muscles (pull the brow inferiorly). Botulinum toxin injection of corrugator and procerus muscles weakens the brow depressors to improve glabellar rhytides. Injections are made above the supraorbital rim to avoid upper eyelid ptosis. Men typically require higher doses due to greater muscle mass in this area [33].

Lateral Canthal Rhytides

Contraction of the lateral orbicularis oculi muscle produces lines (crow's feet) that radiate from the lateral canthus. These lines initially appear on smiling or squinting (dynamic) but can become static (at rest) due of aging, photodamage, and skin remodeling. Crow's feet are treated with multiple botulinum toxin injections into the lateral orbicularis oculi muscle, lateral to the orbital rim with the facial musculature at rest [11,33,79].

Brow Lift

Brow ptosis, a common feature of aging, can produce facial features at rest that mimic angry or scowling expressions. Brow shape and height are controlled by the opposing action of brow elevator (frontalis) and depressor muscles [33]. Botulinum toxin is injected as in treating glabellar lines (above), the lateral orbicularis oculi, and in the lateral corrugators 1–2 cm above the orbital rim to avoid the Mephisto or Spock eyebrow (quizzical look). Injections limited to the superolateral orbicularis oculi muscle (tail of the eyebrow) can give a lateral eyebrow elevation [10,11,33,79].

Hypertrophic Orbicularis Oculi

Botulinum toxin injection can widen the ocular aperture by weakening the orbicularis oculi muscle complex, producing a wider, rounder eye during smiling and at rest [33].

Dermal Fillers

Given the substantial variability in anatomy and aging of the upper face, reversible (hyaluronic acid) fillers may be preferred; clinicians with experience and a level of comfort may consider stimulatory (PLLA) fillers [10,11].

Fillers for temple and upper brow volume loss require elevated elasticity and viscosity for periosteal placement, to give structural and lifting support to overlying tissues with low risk of displacement (e.g., Restylane Lyft, Radiesse, Juvéderm Voluma-XC, Juvéderm Ultra Plus XC) [29]. Fillers for volumizing the upper lid, forehead, and crow's feet should have lower elasticity and viscosity for superficial placement (e.g., Restylane-L, Restylane-Silk, Belotero Balance, Juvéderm Ultra XC) [29].

The anatomic order of contouring influences the ultimate outcome of facial volumization. Augmenting the temple alone may provide lateral brow support and should be addressed before moving more caudally [29]. The upper face is a challenging area for fillers because of risk for serious complications [11].

Temple Volumization

Fillers for temporal volume loss and hollowing intend to eliminate concavity and achieve a uniform or slightly convex contour between the temporal fusion line and the zygomatic arch. Severe volume loss may require multiple treatment sessions [8,11].

Brow and Upper Lid

Volume loss occurs in bone and more superficial tissues including subcutaneous fat and the retro-orbicularis oculi fat pad. To correct this deficit, the initial filler injection is directly onto periosteum 1 cm superior to the upper lateral orbital rim or just above the superior lateral brow hairline [29].

Eyebrow Shaping

The position and/or shape of the eyebrow often changes with aging. Fillers can enhance eyebrow contour and volume and may improve elevation of the eyebrow tail when botulinum toxin provides insufficient eyebrow lifting [11].

Forehead Contouring

Dynamic forehead lines are usually treated with botulinum toxin, but fillers can treat deep horizontal lines to create a smooth contour across the forehead. The filler is injected at least 2 cm above the eyebrow, with the needle tip on bone [11]. For tightening eyelid skin, radiofrequency is preferred because of its efficacy and built-in safety features [10].

THE MIDFACE

In facial aesthetics, the midface is a main determinant of perceptions of facial attractiveness, influenced by synergy of the eyes, nose, lips, and cheekbones (central facial triangle). It is also the focal point for restoration of a youthful topography. As such, the midface should be treated first [4,10,122].

Degenerative changes occur in nearly all anatomic components of the midface. The mid-cheek manifests the most complex soft tissue changes with aging, and volume loss of the deep mid-facial fat is a primary determinant of an aged appearance. Fat within each compartment changes independently over time, losing volume and shifting as the facial ligaments attenuate and the bony skeleton recedes [10,31].

Loss of maxilla projection and skeletal support and inferior displacement of soft tissues contribute to the tear-trough deformity, malar mounds, and prominent nasolabial fold and groove. The cheeks lose projection to assume a sunken appearance. Prominent transitions between cheek fat pads and flattening of the malar prominence mark the deflated midface; the heart-shaped face of youth becomes distinctly pear shaped [10,29,31].

Accurate assessment of midface volume loss is the single most important factor for appropriate correction of facial volume; precise restoration may rejuvenate the upper and lower face [29]. To define these midface areas, draw one line from the lateral canthus to the lateral oral commissure and a second line from the tragus to the nasal ala. The lines intersect to form quadrants. Examine the upper-outer (zygomatico-malar region), upper-inner (anteromedial cheek), and lower-outer (submalar region) quadrants for volume loss and treat accordingly [84,123,124].

The medial suborbicularis oculi fat migrates inferiorly with aging. The medial part of the deep medial cheek fat extends almost to the lateral incisor tooth. Volumizing both medial fat pads is crucial for correcting cheek sagging—a major contributor to deep nasolabial folds [2,40].

Fillers are used for volumization and contouring the upper cheek and lid-cheek junction, the submalar and preauricular areas. Botulinum toxin plays a limited role [125]. Recommendations for the midface advise treating the malar area first; volumizing the malar and restoring its contours gives a lifting effect that may reduce or negate the need for filling other midface areas [30,55]. Careful attention should be paid to restorative effects on the lower lid, nasolabial fold, nasal base, and upper lip during malar augmentation [29].

Malar Area

Fillers are injected to create vertical pillars over the bone to support and lift the malar area. The following injection sequence is lateral to medial, to achieve a tenting effect with less filler needed for medial injection [8,30,94]:

- In the lateral midface, the zygomatic (cheekbone) arch and prominence (crucial for optimal cheek restoration)

- Lateral compartment of the superficial cheek fat pad and the preauricular superficial fat compartment

- Middle compartment of the superficial cheek fat (medial sub-orbicularis oculi fat)

A variety of fillers can volumize the malar/lateral cheek region with good results (e.g., hyaluronic acid, CaHA, PLLA, PMMA) [84].

Lower Lid

Volume restoration of tear trough deformity with filler injection is a difficult technique in a danger zone for vascular complications and should only be performed by experts [84].

Deep Medial Cheek

Volumizing the deep medial cheek fat increases anterior projection, reduces the nasolabial fold, and recreates a youthful cheek within its natural boundaries [25,40]. Juvéderm Voluma XC, Juvéderm Ultra Plus XC, Restylane Lyft, Radiesse, PLLA, and PMMA are all suited for deep midface volumizing [29,84]. Patients with significant orbital fat herniation may benefit more from surgery; fillers alone may be inadequate to reduce the transition between protuberant fat pad and concave tear trough [84].

Nasal Tip and Upper Nasolabial Fold

Deep volumizing of the nasal sill can provide support to the aging nasal tip, a natural correction of the upper nasolabial fold, and a minor lift to the upper lip. Treatment requires periosteal placement of high-elasticity, large-particle fillers [29].

Botulinum toxin can correct "bunny lines"—horizontal rhytides that traverse the nasal bridge and the downward slope of the nose when the patient is smiling—and elevation of the nasal tip [10,125]. In the midface, nasolabial folds are treated last [10].

Nasolabial Folds

Most fillers are indicated for treating nasolabial folds by the FDA, but unlike other midface areas, nasolabial folds hypertrophy with age. Thus, fillers are suggested to soften a prominent fold, not to volumize. First correct deficient malar volume, then soften residual nasolabial folds conservatively using moderate-elasticity and -viscosity filler (e.g., Restylane-L, Juvéderm Ultra XC) injections in the superficial fat just to the dermis [29].

Low-dose botulinum toxin into each lip elevator complex above the nasofacial groove can collapse the upper nasolabial fold but may vertically lengthen the upper lip, an aging-related feature. Botulinum toxin should not be directly injected into nasolabial folds, as this may result in an asymmetrical smile or lip ptosis [33].

After addressing volume loss, microfocused ultrasound treatment of the overlying superficial musculo-aponeurotic system and skin envelope addresses laxity and bridges the aesthetic unit compartments to create a smooth cheek contour [10,126].

THE LOWER FACE AND NECK

During the aging process, bony and soft-tissue structures in the lower face undergo significant alterations [4,10,29,58]. Malar and perioral fat volume loss, bone resorption, and ligament laxity cause increasingly lax skin to droop downward over a changing lower face structure. The general widening and loss of integrity of the lower face can appear as a relative increase in jowl volume with decreased jawline strength and perioral/lip volume.

Jowling is one of the most unwanted effects of aging and a primary concern of aging patients. The jowls become prominent with deflation of superficial fat exposing deeper fat pads, descent of deep fat pads, and increased septal laxity. Loss of volume in the prejowl sulcus, posterior jawline, and inferior preauricular region exacerbates the appearance of jowls.

Superficial and deep atrophy of the perioral area manifests as a lengthening and flattening of the upper lip complex, loss of vermillion and vermillion border volume, and formation of vertical perioral rhytides. The oral commissures turn down, and the mentalis region flattens or becomes ptotic. Protrusion of the central chin results from loss of lateral and inferior volume. These changes are superimposed on and intensified by mandibular bony changes that result in decreased vertical ramus height, a widening mandibular angle, and loss of anterior mandibular (mental) projection. Platysma muscle contraction from support of deeper neck and floor of mouth structures promotes vertical fibrous bands on the neck; laxity in overlying skin creates horizontal rhytides.

Botulinum toxin and filler combinations are especially effective in the lower face to address dynamic musculature, loss of volume and support, and skin laxity [10]. Some believe that fillers are more important than botulinum toxin and should be used first to provide structure and support before considering botulinum toxin for dynamic lines [127].

Jawline

Structural volumizing of the lower face should begin with correction of the jawline, using fillers with high elasticity (Restylane Lyft, Radiesse, Juvéderm Voluma XC, or Juvéderm Ultra Plus XC) [29]. Injector preference/experience will also determine filler choice [10].

Mandibular shrinkage and redistribution of fat leads to the emergence of jowls and loss of jawline definition. To smooth the jawline and camouflage the prejowl, the inferior mandibular border is injected in the supraperiosteal plane. Injection under the mandibular rim improves the prejowl concavity. The jowl is not directly injected, to avoid blood vessels [8,58].

A technique referred to as the "Nefertiti lift" involves small amounts of botulinum toxin injected along the jaw and into the lateral, upper platysmal band to improve the appearance of pouches. With skin laxity, the addition of microfocused ultrasound helps lift the jowls for a tighter appearance [10].

In women, an overly squared jaw can be undesired. If sagging is not an issue, botulinum toxin injection of the masseter results in a softening of the determined, clenched appearance and a more feminine face [65].

Chin

Botulinum toxin injections just anterior to the bony mentum on each side of the midline weaken the mentalis muscle contraction responsible for mental crease, and injections into the mentalis muscle at the prominence of the chin can help reduce a peau d'orange chin [33,65]. Fillers create definition and fill residual depressions. Injection is placed on the periosteum and deep subcutaneous tissue to create vertical pillars. Fillers with greater lift are preferred [8,58].

The perioral region is considered one aesthetic unit, comprising the lips, oral commissures, and melomental folds (marionette lines). Botulinum toxin is commonly used for perioral rhytides but requires caution, as improper injection may result in a flaccid cheek, an incompetent mouth, an asymmetrical smile, or speech pathology [10,79]. Perioral volumization may independently restore and support the lips by enhancing lip volume and should be precede direct mucosal lip volumizing in an aging face [29].

Moderate-elasticity fillers (e.g., Restylane-L, Restylane-L Silk, Juvéderm Ultra XC, Belotero Balance) are injected in the subcutaneous plane, first in the oral commissure until a subtle upturning is achieved, then in the upper and lower lip columns for volumizing support. This will improve the appearance of vertical lip rhytides and philtral columns [29].

Vertical perioral rhytides are common cosmetic concerns, induced or exacerbated by repetitive orbicularis oris muscle contraction. With fillers, a short-lived improvement and fairly rapid recurrence is likely caused by normal perioral animation. Low-dose botulinum toxin is injected adjacent to the vermillion border in the areas of rhytides, and lateral to the Cupid's bow area of the lip. Avoid injecting the oral commissures (corners of the lip) and the midline area to reduce the risk of a drooping lateral lip [33].

Mouth frown results when the depressor anguli oris muscle pulls the corners of the mouth downward, in opposition to the action of zygomaticus major/minor muscles, producing a frowning expression. Botulinum toxin injection weakens the depressor anguli oris, allowing the zygomaticus to elevate the corners of the mouth, which return to a horizontal position. Botulinum toxin is injected into the insertion point of the mentalis muscle, because upward pull of the mentalis contributes to mouth frown [33].

Melomental folds (marionette lines) are exacerbated by contraction of the depressor anguli oris muscle. This is treated by botulinum toxin injection into the posterior margin of each depressor anguli oris immediately above the mandible [33].

THE NECK

Platysmal bands, often the first sign of aging of the neck, appear as two vertical, bulky cords from the lower border of the mandible to the suprasternal region. Formerly thought to result from skin laxity and loss of platysma muscle tone, these vertical muscular bands are now attributed to platysma muscle activity, treated by denervating the platysma muscle with botulinum toxin instead of tightening the skin [128]. Very-low-dose botulinum toxin is injected superficially into only specific platysmal bands, to avoid dysphagia [79]. Improvement of the overall appearance of the neck requires fillers for structural support of the chin and jawline and botulinum toxin for the masseter, platysmal bands, or horizontal neck lines [33,127].

10. PATIENT SELECTION AND EVALUATION

As discussed, the careful assessment of patients forms the basis of individualized treatment planning. Because aesthetic procedures are elective, the benefits must clearly outweigh the risks. Healthcare providers have a responsibility to refuse requests in which the risk-benefit ratio is not in the patient's best interest, and to refer patients elsewhere for consideration of treatments the clinician cannot or prefers not to perform. Patients rely on the healthcare provider to act as a "learned intermediary" and to exercise fiduciary responsibility in advising the patient on the best course of action [95].

Patients should be carefully selected by thorough assessment of medical history, motivation, and expectations to identify contraindications. The increasing incidence of serious dermal filler complications has expanded the cutaneous and systemic contraindications to filler treatment, relevant to botulinum toxin because combined therapy is common.

Following screening, careful discussion addresses the specific cosmetic concerns and possible benefits and risks across a range of available options. A treatment plan is arrived at through shared decision-making; informed consent and documentation are made.

For those who are not proficient in English, it is important that the patient history and information regarding the risks associated with the use of botulinum toxin/dermal fillers be obtained in the patient's native language, if possible. When there is an obvious disconnect in the communication process between the practitioner and patient due to the patient's lack of proficiency in the English language, an interpreter is required.

SCREENING AND SELECTION

Screening and Assessment of Medical Contraindications

The patient may request a cosmetic therapy, but the aesthetic provider should ultimately "select" the patient. Most complications stem from inappropriate patient selection, inadequate antiseptic preparation, or improper treatment technique. Selecting appropriate patients, or perhaps more importantly, not treating inappropriate patients, is the first crucial step in avoiding complications [71].

A thorough history of skin conditions, allergies, systemic disease, current medication use, and previous cosmetic procedures is mandatory. Patients may not see important aspects of their history as relevant. To help ensure disclosure, assess skin-related and systemic conditions by linking to potential adverse effects [19,71].

Some skin disorders and local or remote infections can promote injection seeding of infective agents that populate the filler site, or hematogenous spread to implanted fillers and later biofilm formation or transition from infection to hypersensitivity [19,129,130]. These conditions require careful screening. Fillers have risks of injection-site keloid formation or hyperpigmentation; patients with these conditions should avoid fillers [75].

Screening may identify conditions whereby filler therapy is contraindicated, deferred until resolution, or considered cautiously. Significant comorbidity, polypharmacy, or use of immunomodulatory drugs can greatly complicate adverse effect management if it becomes necessary [22].

Screening and Assessment of Psychological Contraindications

Understanding the motivations for cosmetic treatment is vital to minimizing inappropriate patient selection. Unrealistic expectations, which are contraindications to cosmetic treatment, are prevalent in some psychological conditions [19,75]. Low self-esteem can lead to unrealistic goals and expectations. High neuroticism and/or anxiety may influence expectations, and outcomes tend to be poorer [131]. The most important mental disorder consideration is body dysmorphic disorder.

Body dysmorphic disorder is a psychiatric disorder characterized by preoccupation with an imagined defect in appearance or distorted perception of one's body image. These patients may be unduly invested in the cosmetic procedure as the solution to other life problems. Unrealistic expectations are followed by dissatisfaction with results that do not correlate with objective outcomes [132,133]. Dissatisfied patients with body dysmorphic disorder have been reported to retaliate against their cosmetic providers with lawsuits, threats of violence, physical assault, and in rare cases, homicide [134,135].

Compulsive behaviors have been described in patients who, driven by the quest for physical perfection, demand and obtain multiple sequential cosmetic injections despite the increasing risk. Compulsive demand for cosmetic procedures falls on a spectrum of dysmorphophobic behaviors [136,137]. Body dysmorphic disorder is also associated with "doctor-shopping" [131].

Whether the diagnostic threshold for body dysmorphic disorder is a contraindication to nonsurgical cosmetic procedures is unresolved, but many consider signs of body dysmorphic disorder a firm contraindication to cosmetic treatment [19,131,132,138]. Appropriate onward referral may be required when psychopathology is apparent [131,139].

PATIENT EVALUATION AND CONSENT

After the patient has been screened for medical and psychological contraindications to cosmetic treatment, the next step is to determine if treatment expectations can be met or managed with education and counseling. Following this, treatment options are explored and a plan is developed and documented.

Patient Motivation and Treatment Expectations

American healthcare consumers are both aging and youth-oriented [94]. A majority of the population is dissatisfied with their appearance, rates of cosmetic interventions continue to increase, and the expectations of many patients have risen proportionately [131].

Patient motivation for cosmetic therapy, benefits anticipated, and satisfaction with the outcome are closely inter-related. The expectations and motives for seeking treatment are complex and diverse. Patient dissatisfaction usually derives from failing to manage or meet expectations, underscoring the importance of identifying expectations at the first consultation and documenting this discussion [131]. The clinician should establish underlying motivations, differentiate patient wants from needs, and temper expectations within realistic goals [19].

Patient motivation is considered external when expecting physical changes to influence some aspect of their life (e.g., partner will love them more, career success). Unrealistic expectations with external motivation require discussion, as these patients are more likely to be dissatisfied with outcomes. In contrast, internally motivated patients (driven by a desire to look better for themselves) are good candidates [131,138].

Other factors can influence expectations [94,131]. Younger patients can be especially sensitive to peer group acceptance and social media images, but correction of an objectively undesired feature can also be therapeutic. Traditional and digital media promote unrealistic expectations of an idealized appearance, and along with marketing, this has led some patients to believe a youthful appearance can be maintained indefinitely, has a quick fix, or is guaranteed with a "miracle treatment." Partners, families, and friends can exert strong influences that can be helpful to separate from the patient's own expectations. Expectations tend to be higher among more educated patients.

Expectation Management

Patient expectations should be managed so they do not envisage an unrealistic outcome. The treatment of inadequately informed patients is fraught with potential problems and risks of dissatisfaction [71].

Patient education on the risks, potential benefits, and limitations of cosmetic procedures may modify expectations. Good information is associated with better outcomes, and hearing these details may lead the patient to prefer a different course of treatment than first proposed [131].

A 2016 guideline stresses the importance of giving prospective cosmetic patients time to reflect on what they learned during the initial consultation—a "cooling-off period" [140]. However, a 2015 consensus statement suggested initiating at least part of the treatment plan the same day to build patient confidence in aesthetic procedures and in the clinician [94]. It may be best to assess on a patient-by-patient basis which approach is appropriate.

The FACE-Q is a validated screening instrument that measures patient expectations of cosmetic treatment, such as appearance-related psychosocial distress and how they expect their appearance and quality of life to change after cosmetic treatment [141]. Use of the FACE-Q can help augment, but not replace, patient-clinician discussions of factors that influence expectations of cosmetic treatments [131].

An effective approach to expectation management is the mnemonic STEP [94]:

- Stress what can and cannot be done with minimally invasive aesthetic treatments.

- Target specific areas of patient concern.

- Envision what the effect of the aesthetic outcome would be like to the patient.

- Preframe the patient to the expected outcome.

Developing a Treatment Plan

The clinician should be both probing and empathetic. Patients may be ashamed they look older than their peers but too embarrassed to directly discuss it. Others may see their concerns as vain and frivolous. Many patients are unaware of the range and versatility of cosmetic procedures or believe their concerns are beyond remediation [94]. Keep the focus on cosmetic concerns rather than any preconceived treatment approach.

Educate the patient to focus on the underlying cause, not the superficial manifestation, of her/his cosmetic complaint. For example, sagging skin is often caused by volume loss, making volume augmentation the appropriate treatment [94].

Discuss realistic expectations for the results of specific treatments. For example, if a patient requests a specific treatment for prominent nasolabial folds with the goal of looking younger, explain that nasolabial folds can be treated directly, but would not produce a more youthful appearance—correcting the underlying volume loss could restore a youthful appearance, even with some residual folds [94].

Many patients have concerns about several facial areas. Asking: "If you could fix only one thing today, what would it be?" can help clarify their relative priorities to base a reasonable sequence of procedures [94].

Clarify expectations of time frame to determine what is realistic and feasible when patients require the desired effects before an important event, such as a wedding. Other patients may want progressive, rather than immediate, aesthetic improvement. Also understand the degree of patient risk tolerance in treatment selection [94].

Discuss the implications of botulinum toxin treatment of the orbicularis oris muscle. The reduction of fine motor control around the mouth may be detrimental to professional speakers, vocalists, or musicians [94].

Informed Consent and Documentation

The risk of malpractice claims is highest in cosmetic medicine. Most result from inadequate informed consent instead of procedural failures [16]. To fully inform decision-making and consent to treatment of patients, carefully discuss the possible benefits, disadvantages, and limitations over a broad range of options [7,95].

Beyond an unnatural look, the three main patient concerns are pain, complications, and costs. It is essential to discuss treatment costs, obtain financial consent, and plan over the long term to obviate financial stress. Addressing these issues upfront is instrumental in establishing the trust that underpins true patient satisfaction [19].

Shared decision-making, an essential element of evidence-based medicine, explores available treatment options, possible benefits and harms of each option, and best match to the patient's characteristics and preferences [142]. Obtaining signed informed consent is crucial in creating awareness and acceptance of potential complications. An informed consent document confirms patient understanding of the potential adverse effects and expected treatment outcome. The document should outline common and uncommon but serious adverse events. Supplying written pre- and post-instructions during the initial consultation can help to establish realistic expectations and minimize dissatisfaction [19,34].

Photographic documentation is essential for medico-legal purposes and appraisal of results. To ensure good quality pre- and post-treatment photographs, the patient should remove all makeup and jewelry and pull hair back or up using a hairband; a black/dark background is preferred. Multiple images at rest and during animation are recommended, including anterior, oblique, and lateral views with the head in a neutral, neck-extended, and neck-flexed position. Proper lighting, consistent angles, and a fixed camera distance are mandatory. A single-lens reflex camera and tripod are recommended instead of smartphones [19].

11. ADVERSE EFFECTS

As mentioned, there is increasing concern of serious adverse events involving dermal filler injections. Some experts noted that by 2010, the increasingly sophisticated training in nonsurgical cosmetic treatment was already neglecting adverse events and their management [22]. With the rapid growth in consumer demand for injection cosmetic therapies, the quality of training, skill, and credentialing of injectors and facilities are increasingly unclear. Along with inadequate regulation, the net effect is described as compromising not only patient safety but the reputation of the field [19,20,23].

With serious adverse events a focus of concern, there is an expansion of recommended measures to prevent, reduce, and manage adverse events before they become disastrous complications.

PREVENTION AND RISK REDUCTION

Several approaches are recommended before injection therapy to prevent or reduce complications by mitigating patient, clinician, or procedure risk factors.

Pretreatment Patient Management

Some complications may be prevented by careful pre-treatment patient management. Filler injection can reactivate latent herpes simplex virus (HSV) infection. Prophylactic antivirals (e.g., acyclovir, valaciclovir, famciclovir) are recommended with patient history of HSV in the intended injection area. Patients with a current outbreak of HSV should receive antivirals, with fillers deferred until resolution of herpes lesions [143,144]. For two to four weeks before and after filler treatment, patients should be counseled to avoid [92,143,144]:

- Dental procedures, oral hygienist visits, tooth bleaching/whitening

- Immunizations/vaccinations

- Other medical procedures

- Any facial procedure inducing inflammation or skin barrier disruption

In addition, products with blood-thinning effects should be avoided the week before filler treatment. This includes food/beverages (e.g., red wine, dark chocolate, grapefruit) and certain supplements/over-the-counter medications (e.g., vitamin E, gingko biloba, fish oils, St. John's wort, nonsteroidal anti-inflammatory drugs [NSAIDs]). Prescribed anticoagulants (e.g., aspirin, warfarin, clopidogrel, apixaban, rivaroxaban, dabigatran) should also be withheld, but only when cleared by the prescribing physician [92,143,144].

A pretreatment checklist should be provided to the patient that includes these points and explains the importance of having any infective or inflammatory conditions treated before the procedure; the treatment should be rescheduled if the pretreatment checklist is incomplete. The patient should receive the checklist with sufficient time to plan relevant medical visits around the treatment date. Contact patients one week pretreatment to ensure they possess and understand the checklist and have no precluding factors [19].

Procedure- and Clinician-Related Factors

Knowing previous surgical (e.g., rhinoplasty) or nonsurgical cosmetic procedures and locations is vital to prevent complications. Fixation, scarring, or alteration of underlying vasculature and anatomy at procedure sites can facilitate intravascular filler injection. "Layering" new fillers over a previously injected semi/fully intact filler can provoke dormant biofilm or inflammatory response [19,71,145].

Vascular Complications

Vascular occlusion from injected filler material may lead to potentially catastrophic complications of tissue necrosis, blindness, or stroke. Even with advanced knowledge of facial anatomy, vascular injury cannot be avoided with 100% certainty. However, measures can be taken to help reduce risks and mitigate intravascular adverse events if they develop. A key step is understanding the danger zones for vascular occlusion, areas where arteries have little or no collateral circulation, extensive anastomoses with the internal carotid artery, or are prone to external compression. Risk factors for vascular occlusion are summarized in Table 7[19,146,147]. Table 8 outlines strategies to mitigate these potential complications.

Table 7: RISK FACTORS FOR VASCULAR COMPLICATIONS DURING FILLER INJECTION

Factor

Description

Injection site danger zones

Injections to the nose, nasolabial fold, forehead, and glabella are at increased risk for blindness.

Injections to the glabellar region, nasal tip/alar triangle, and lips increase the risk for necrosis.

Injected volume

Bolus injections near danger zones increase risk of necrosis.

Filler type

Non-hyaluronic acid fillers cannot be dissolved.

Necrosis is more common with denser or more permanent fillers.

Needle gauge

Sharp needles puncture arteries more easily. Aspiration before injecting is suggested, but unreliable. Blunt cannulas are less likely to puncture vessels.

Scarring

Scarring from prior cosmetic procedures or trauma can alter the local vascular pattern.

Source: [70,145,146,147,148,149,150]

Table 8: RISK MITIGATION STRATEGIES FOR FILLER-RELATED VASCULAR COMPLICATIONS

Step

Recommended Strategy

Knowledge

Know injection-site vascular anatomy, and be aware of inter-patient variations.

"Go easy"

Inject slowly, and apply the least amount of pressure necessary. Keep the needle moving. Restrict bolus injections to periosteal plane.

Monitor closely

Watch for blanching or any changes in skin color.

Be aware

In a vascular occlusion, epinephrine can mask skin blanching, and local anesthetic or lidocaine can mask pain.

Listen to your patient

Immediately stop injecting if resistance is encountered, or if patient reports pain, discomfort, or changes in vision.

Have a plan

Onsite protocols for immediate, early, and late adverse events should be easily accessible.

Discharge instructions

Describe in writing the signs/symptoms of vessel occlusion and where and why to seek medical attention.

Staff education

Educate clinic staff on accurate assessment and appropriate referral of patients who report filler adverse events.

Report the incident

Report vascular compromise adverse events to the FDA and filler manufacturer.

Source: [70,145,146,147,148,149,150]

Infection Risk

To minimize infection, stringent aseptic technique is mandatory [19,151]. Prior to any intervention, it is vital to clean, degrease, and disinfect the patient's skin. Remove makeup and cleanse carefully with 2% chlorhexidine in 70% alcohol, avoiding ocular exposure. When treating the perioral area, consider antiseptic mouthwash containing chlorhexidine or povidone-iodine for sterilizing the oral cavity.

The clinician should remove all jewelry, wash hands with antiseptic cleanser, and use gloves for all injections. Once the syringe is held, sterility is lost and aseptic technique is crucial. Not touching any needle or cannula component that penetrates the skin may further reduce infective complications. Cleansing a broad area avoids infective risk from inadvertently resting a cannula on adjacent uncleaned skin. Frequently change needles/cannula when using multiple entry points.

Biopsy can play a crucial role in diagnosing and treating filler-related adverse events, but cosmetic patients strongly resist facial biopsy unless absolutely necessary. A medicolegal process is always justified [152].

After treatment is administered, it is important to assess the patient's response. Clinicians should routinely check perfusion in treated and watershed (e.g., glabella, nasal tip, upper lip) areas [19]. Consider that makeup can obscure skin tone and signs of vascular compromise. Patients should be furnished with written post-treatment instructions and contact numbers. A follow-up call to the patient should be made within 24 hours, and the clinician/clinic should be available by phone for 48 hours postprocedure [19].

All facilities should have easily accessible protocols for early and delayed-onset reactions [19]. Resuscitation measures (e.g., epinephrine, IV access, fluids) and an adequate supply of hyaluronidase should be kept on hand, with regular checks of expiration dates on emergency drugs. In addition, contact information for an ophthalmologist or oculoplastic surgeon experienced in treating retinal artery occlusion should be maintained.

Anesthesia/Analgesia

Pain control is crucial to ensuring a positive experience for patients [76]. Topical anesthetics or local nerve blocks are commonly used to reduce pain, although many fillers are also formulated with lidocaine. To reduce pain, use the smallest suitable needle, slow infiltration, and the least needle punctures necessary. Other measures to help reduce pain include ice application, skin vibration, patient distraction, and a relaxed, soothing treatment environment [34].

COMMON ACUTE SIDE EFFECTS

Pain, bruising, redness, itching, and swelling are common, self-limiting side effects following dermal filler injections. Persistence beyond seven days should be closely assessed [144].

Pain

Pain is relatively common and is more likely with multiple needle punctures. However, pain may also be a sign of impending vascular compromise, discussed in detail later in this course. Pain can be minimized by using slow needle introduction, ice anesthesia, and filler warmed to body temperature [70].

Erythema

Erythema (redness) usually resolves without treatment. Longer-lasting or persistent erythema suggests hypersensitivity reaction or infection and requires careful evaluation. Oral tetracycline, isotretinoin, topical tacrolimus, or medium-strength topical steroids are suggested for persistent erythema; long-term, high-potency topical steroids should be avoided. In severe cases, oral propranolol (20 mg) can make erythema less evident [70,143].

Edema

Evidence Based Practice Recommendation

If ice is used to control pain following botulinum toxin or dermal filler injection, the Australasian College of Dermatologists recommends placing it inside either a sterile glove or a nonsterile glove, then wiping the glove with alcohol or chlorhexidine to sterilize it, as ice is not sterile. Alternatively, frozen gel packs may be used in the same way.

https://onlinelibrary.wiley.com/doi/full/10.1111/ajd.13273

Last Accessed: March 19, 2024

Level of Evidence: Expert Opinion/Consensus Statement

Edema (swelling) in the first few days is normal with all fillers and can be managed by gentle pressure and ice packs [83]. Episodic swelling and edema following filler injection can occur after sun exposure, exercise, or saunas. It is important not to confuse normal edema with allergic reaction; manage with ice packs, topical steroids, and avoidance of vasodilating stimuli [70].

Ice is recommended and commonly applied on the injection site to prevent and manage pain and edema, but it has also been associated with infection. An Oregon plastic surgery clinic described an outbreak of facial Mycobacterium chelonae infection (presenting as swollen skin nodules with drainage or discoloration three to six weeks after inoculation) following filler injections. The infections required three to four months of multiple oral or IV antimicrobial agents to resolve. The source was traced to clinic tap water, used for ice applied immediately pre- or post-injection [153]. As such, cold packs rather than ice may be safer options.

Bruising

Bruising, hematoma, and ecchymosis can result from needle pricks and bleeding. This can be minimized by firm pressure on the needle insertion site and prevented by cessation of alcohol and supplements with anticoagulant effects one week before treatment. Intense pulsed light and vascular lasers have been used to treat persistent symptoms [70].

Lesions

Papulopustular lesions occur when filler injected too superficially in the papillary dermis occludes, or extrudes through, sebaceous or sweat gland openings and mimics bacterial infection or acneiform eruption. Post-injection massage can help in prevention, and topical astringents can help in their resolution [70].

Overcorrection can appear as bumps, nodules, or irregularities when too much material is injected. In these cases, hyaluronic acid products should be resolved using hyaluronidase. With non-hyaluronic acid fillers, puncture and drainage of excess product may suffice [70].

INFREQUENT ACUTE ADVERSE EVENTS

Dysesthesias and Paresthesia

Dysesthesias and paresthesia are symptoms of nerve injury following direct trauma, injection of filler into a nerve, or tissue compression by the product. Nerve damage is usually transient and reversible, infrequently permanent, with the infraorbital nerve the most common site [143].

Intracranial Penetration

For deep periosteal or supraperiosteal injections, the needle is advanced to the level of the bone and retracted slightly. Accidental intracranial penetration is a demonstrated risk, but the prevalence is unknown [70].

VASCULAR COMPROMISE

Vascular compromise is the result of vascular occlusion following inadvertent intravascular filler injection or vascular compression by adjacent filler material. Embolism occurs when filler material enters the vasculature, impeding blood flow. Vascular compromise can involve arterial or venous occlusion [70,143,150].

Areas at highest risk of embolism have minimal collateral circulation (the nose), terminal blood supply (the glabella), large vessels (the nasal artery), or large areas (forehead) supplied by a vessel with minimal collateral circulation (terminal supratrochlear artery) [154]. Embolization of filler material is a potentially catastrophic complication with possible sequelae of tissue necrosis, blindness, or cerebrovascular accident. The literature is replete with examples of permanent blindness following hyaluronic acid, PLLA, or CaHA filler injections [122,155]. Intravascular injection occurs more frequently than assumed. In a study of expert aesthetic physicians, 62% reported inducing one or more such events [156].

Tissue Necrosis

With embolism induced by intra-arterial injection, damage to endothelial cells leads to ischemic changes in the skin, tissue degradation, and necrosis [71]. Cells undergoing necrosis swell and then burst, releasing their contents to trigger a local inflammatory reaction, with swelling, pain, heat, and redness. Intra-arterial injection can lead to embolism, platelet aggregation, subsequent occlusion in a terminal branch, and delayed-onset necrosis [145].

Necrosis can follow vascular occlusion due to vessel compression by filler material or filler-induced tissue swelling, and onset can be delayed. Tissue necrosis can occur with all dermal filler types but is more likely with particulate fillers [83,145]. With blood supply reliant on a single arterial branch, the glabella, nasal ala, and nasolabial folds are most vulnerable to necrosis [70,83].

The cardinal features of vascular occlusion and necrosis are changes in skin color and pain [70,71,145,150]. Skin blanching and severe pain are immediate with arterial occlusion. However, as noted, epinephrine use may mask blanching, and pain may not fully appear until local anesthetic or nerve block wears off. If not swiftly resolved, the affected skin will develop reticulated erythema, purpura, ulceration, and scarring.

With venous occlusion, red/bluish skin color changes appear immediately to hours later, with or without pain, progressing to blisters, pustules, and tissue necrosis within a few days.

Blindness

The most feared complication of filler injections is blindness following occlusion of the central retinal artery, the final branch of the ophthalmic artery. Comparing average diameters, injected hyaluronic acid filler particles (400 mcm) easily move through the ophthalmic artery (2 mm) to block the central retinal artery (160 mcm) [122,154,157].

The routes to occlusion and blindness vary by proximal branch of the ophthalmic artery inadvertently injected. When the force of injection exceeds intra-arterial pressure, the injectate can move proximally in the angular artery and then proximal of the origin of the central retinal artery. With pressure on the syringe released, the material moves distally into the retinal artery. Central retinal artery occlusion follows injection into the glabellar region (through the supratrochlear artery into the supraorbital artery) or the nasolabial fold (in any anastomosis of the dorsal nasal artery from the ophthalmic artery) [154]. Blindness, visual field deficit, or blurring is instant, often with excruciating ocular pain [70,83,143].

Stroke

With greater pressure on the plunger or for a longer time, the filler may travel into the internal carotid artery and then enter cerebral circulation, producing a stroke [122,150]. Unilateral blindness and left-sided hemiplegia immediately following glabellar area injections are reported. However, these effects are rare with dermal fillers and more likely with autologous fat injections [70]. Pulmonary embolism and panophthalmoplegia have also been reported with filler injections [19].

Management of Vascular Compromise

Intense pain is considered an initial sign of intravascular filler injection, but as noted, it may be obscured by lidocaine in fillers or by local anesthetic. Vigilance for skin color change is mandatory [19]. With any suspicion of vascular occlusion from inappropriate pain, skin blanching, or mottled discoloration, immediately stop injecting and aspirate any product when withdrawing the needle (if possible). It is vital to facilitate an immediate, aggressive response to remove the product and promote blood flow [19,71].

Hyaluronidase Reversal

With hyaluronic acid fillers, hyaluronidase injection is the foundation of emergent therapy for most adverse events, a powerful advantage of these products, as no other dermal filler material has a reversing agent [19]. Hyaluronidase injection enzymatically dissolves the hyaluronic acid filler material [68].

Evidence Based Practice Recommendation

Hyaluronidase has also been shown to diffuse into the lumen of blood vessels even when injected external to it. According to the Aesthetic Complications Expert Group, for potential cases of necrosis due to intravascular deposition of hyaluronic acid, it is not essential to inject directly into the vessel—injection into the surrounding area is also likely to result in dissolution of the product.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6057733

Last Accessed: March 19, 2024

Level of Evidence: Expert Opinion/Consensus Statement

Hyaluronidase is indispensable in resolving acute hyaluronic acid filler adverse events. All clinicians who provide hyaluronic acid filler injection should always have an adequate supply of hyaluronidase in the office for emergencies and regularly check the product expiration date [122].

Hyaluronidase is recommended in vascular compromise from all filler types to reduce edema and potentially decrease vessel-occluding pressure. When injected immediately, hyaluronidase degrades hyaluronan, a potent proinflammatory mediator associated with tissue necrosis [58,71].

High-dose hyaluronidase (500–1,000 IU) mixed with lidocaine is injected in the affected vessel, the surrounding path of the vessel, and its terminal branch; a large-bore cannula avoids bruising that obscures signs of improving skin color. Doses up to 1,500 U may be used if needed; the consequences of inadequate dosing are dire. Repeat hourly for three to four hours and daily for at least four days or as long as signs of ischemia persist [71,146,158,159].

Injecting high-dose hyaluronidase diluted with lidocaine induces vasodilation and hyaluronic acid dispersion and, with saline, allows coverage of a larger area [71]. Vigorously massage the treated area during and after all hyaluronidase injections to optimize the results and aid mechanical breakdown [158].

Because anaphylaxis is a potential side effect of hyaluronidase and skin testing for hypersensitivity reaction is not an option in emergencies, risk mitigation requires full resuscitation equipment on site and training in its use [34,95,158].

Promote Blood Flow to the Affected Area

Evidence Based Practice Recommendation

For necrosis following dermal filler injection, nitroglycerin paste (rectal paste, used off label) can be applied under an occlusive dressing for several days. The Aesthetic Complications Expert Group recommends applying for 12 hours and then removing for 12 hours until clinical improvement is seen or until it is no longer tolerated.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6057733

Last Accessed: March 19, 2024

Level of Evidence: Expert Opinion/Consensus Statement

Apply warm compresses, and vigorously massage or tap the area. To limit platelet aggregation, clot formation, and further compromise, the patient should be administered two tablets (650 mg) of aspirin to chew and swallow, followed by 75 mg per day until necrosis resolves [19,71,145].

Some experts recommend nitroglycerin paste 2% to promote vasodilation [70,145,160,161]. However, others caution against its use before the hyaluronic acid has dissolved with two or three days of treatment, as dilation of adjacent unobstructed vascular pathways may propagate the embolus toward the orbital area [19]. Low-molecular-weight heparin has also been used in the management of patients with filler-induced vascular occlusion [34].

Additional Recommendations

Necrotic cells and tissue invite opportunistic infection. The measures needed to promote healing and prevent further complications depend on the extent of necrosis and range from appropriate dressing and wound care with topical and/or oral antibiotics to surgical debridement for removal of dead tissue. Susceptible patients may require antiherpetic medication with perioral-area necrosis [145].

Necrosis can be very painful, and pain management should be considered. While over-the-counter analgesics may be adequate in some cases, more severe pain can require opioids [145]. Because necrosis can cause significant scarring and distress to patients, practitioners should prepare for a possible malpractice claim filed by the patient [145].

Ophthalmic Events

An ophthalmic event is a medical emergency, with 60 to 90 minutes the absolute time window for saving vision. Blindness from central retinal artery occlusion is resolvable following hyaluronic acid filler injection only with rapid intervention by retrobulbar injection of hyaluronidase. Occlusion longer than 60 to 90 minutes is irreversible [19].

An ophthalmologist or oculoplastic surgeon should be contacted immediately and the patient transported to the clinic. The general emergency department is inappropriate [122].

To save vision, a needle is advanced in the inferotemporal quadrant of the orbit, inferior and lateral to the optic nerve, with hyaluronidase 2–4 cc (150–200 U/mL) injected into the inferolateral orbit [122]. Attempt rapid ocular pulsed massage. Having the patient hyperventilate in a paper bag may promote retinal vessel dilation. If possible, annotate the time of the vascular event and the visual acuity if lack of light perception or loss of vision occurs [19].

ALLERGIC/HYPERSENSITIVITY REACTIONS

Acute infections appear as acute inflammation or abscesses at the injection site. If left untreated, the initial reddening and hardening can result in fistula formation, discharge of pus and filler, and potentially permanent disfigurement [162].

Hypersensitivity/allergic reactions occur when injected filler material triggers an immune response. Etiology differs by post-injection onset: acute (minutes to hours) or delayed (within days) [19,71,143,163].

Acute Hypersensitivity Reaction

Type I hypersensitivity reactions, mediated by immunoglobulin E (IgE), may present with angioedema or anaphylaxis. Check vital signs; anaphylactic shock is a medical emergency. Angioedema can also progress to airway obstruction. Any systemic manifestation should be considered impending anaphylaxis and treated as such. This involves immediately administering IV epinephrine; if insufficient to maintain perfusion, consider additional vasopressor agents (e.g., dopamine, norepinephrine, glucagon). H1-receptor antagonists (plus cimetidine) are recommended for histamine-induced hypotension.

Hospital admission should be considered for more severe cases, as late-phase reactions may occur more than 36 hours after onset. If possible, remove the dermal filler using hyaluronidase as needed.

Delayed Hypersensitivity Reaction

Type IV hypersensitivity reactions, mediated by T lymphocytes and not antibodies, usually present with induration, erythema, edema, or various types of skin lesions, including painful erythematous nodules. Management consists of cold compresses for localized angioedema and H1-receptor antagonists for histamine-induced hypotension and pruritus. H2-receptor antagonists, oral corticosteroids, and ibuprofen are additional measures.

DELAYED COMPLICATIONS: INFLAMMATION OR INFECTION?

Understanding of delayed dermal filler adverse events and pathogenesis has been a slowly evolving process, impeded by the inconsistent terminology describing these adverse events [148,152]. Delayed filler adverse events have long been considered foreign body immune responses or type IV immunologic reactions to filler materials or contaminants from production, reinforced by negative bacterial culture tests of pus from nodules and the low-grade nature of most inflammations [69,144,150,164]. Sporadic findings of bacterial infection in late-onset nodules were often ascribed to departures from antiseptic standards in skin prep or handling of fillers [165,166]. However, steroid or high-dose NSAID therapy to suppress a presumed inflammatory/immune response led to worsened inflammation and abscesses in some patients, who often required IV antibiotics or surgery [22,162].

In 2009, molecular diagnostics with fluorescence in situ hybridization and advanced imaging established bacterial colonization of tissue and filler material as the causality of chronic inflammation and nodules [165,167,168]. In 2010, the role of biofilm in late filler complications gained attention, helping explain adverse reactions to steroid therapy. These dense bacterial colonies on surfaces secrete extracellular polymers, forming a protective matrix against host defenses and antibiotics. Knowledge of biofilm involvement improved the characterization of filler adverse events [152,162].

A foreign body granuloma results when immune response, unable to enzymatically degrade a foreign body, forms lymphocytic inflammation and fibrosis entrapping the body, preventing its migration. Foreign body granulomas are histologically distinct from inflammatory nodules [70,71,150].

Foreign body granuloma formation can involve biofilm which, protected from host immune response, remains semidormant until activated months or years later by host conditions that favor replication (e.g., new filler injection, dental/medical surgery, local or remote infection, trauma). Activated biofilm can cause an immune response, granulomatous inflammation, abscesses, or nodules, and flu-like illness can precede late-onset nodules [19,22,69].

Thus, late-onset nodules or granuloma may represent an immune/inflammatory response secondary to biofilm-colonized filler. Clinical differentiation is challenging. Foreign material in the dermis or sub-dermis can lead to sterile abscesses, granulomas, cellulitis, or nodules. Infection months or years after injection may have similar signs, varying from erythema, edema, inflammatory nodules, and pain/itching to systemic responses [165].

Therapy for late-onset nodules or granuloma consists of [19,68,69,150]:

- Oral antibiotics with immunomodulatory and anti-inflammatory efficacy, with a macrolide (e.g., clarithromycin) or a tetracycline (e.g., minocycline or doxycycline)

- Systematic and intralesional corticosteroids

- Topical tacrolimus (0.1%) or pimecrolimus (1%)

- Intralesional 5-fluorouracil

- Laser treatment

- Surgical excision

Biofilm in Dermal Filler Infections

Biofilm as an increasing concern is reflected in surgical and infectious disease practice guidelines; uptake in cosmetic/aesthetic medicine is more recent. The skin is understood as a microbiota ecosystem, colonized by diverse micro-organisms. In normal skin flora, most bacterial constituents are harmless. Some are beneficial, such as Staphylococcus epidermidis, which inhibits the growth of pathogenic Staphylococcus aureus[169,170].

Evidence Based Practice Recommendation

To minimize the risk of contamination and infection, the Australasian College of Dermatologists asserts that stringent hygiene, including the use of antiseptic non-touch technique at all times, is essential when fillers are injected. Because filler injections necessitate using hands to stabilize or pinch the skin, clinicians should perform antisepsis frequently during the procedure. They also note that sterile gloves may provide a false sense of security; therefore, they advocate changing gloves after preparing syringes for injection and marking the face.

https://onlinelibrary.wiley.com/doi/full/10.1111/ajd.13273

Last Accessed: March 19, 2024

Level of Evidence: Expert Opinion/Consensus Statement

S. aureus, the most commonly isolated pathogenic bacteria in surgical-site infections, colonizes tissue and artificial surfaces and is found on 30% to 60% of healthy Americans. A disturbed balance of the skin ecosystem can favor S. aureus proliferation and biofilm [171,172,173,174].

On unbroken skin, S. aureus can remain asymptomatic; on injection sites, it can seed infections. The needle breaks the skin barrier, picking up bacteria that are delivered into the dermal filler and setting up infection in the tissue. Preoperative skin preparation for open surgery fails to remove 20% of resident skin flora [21,165,175].

Dermal filler skin prep is less stringent than presurgical site prep. However, it is important to remember that Isopropyl alcohol, chlorhexidine, and povidone iodine are demonstrably insufficient in preventing S. aureus biofilm transfer to tissue during filler injection [165,170].

S. aureus biofilm-seeded hyaluronic acid injections have been linked to bacterial infection in studies comparing subjects who developed late infection to complication-free subjects, matched on age and hyaluronic acid treatment (e.g., filler properties, injections, volume). Bacterial skin flora were cultured from nasal swabs in both groups and filler injection sites in patients with late bacterial infection repeatedly over 12 months [164]. S. epidermidis dominated the bacterial flora on facial skin in 100% of subjects without complications, but pathogenic S. aureus and Klebsiella spp. dominated the bacterial flora on the facial skin of subjects with late bacterial infection. Late bacterial infection was diagnosed a mean 5.5 months after filler injection; pus and inflammatory tissue cultures were negative for bacterial growth. No subjects consented to biopsy, but exhaustive exclusion of other etiologies suggested bacterial biofilm infection [164].

Concerns of Antibiotic Resistance

Bacteria in a biofilm matrix exchange DNA mutations to spread antibiotic-resistant genes and biodiversity. As biofilms mature, antibiotic and antimicrobial resistance strengthens [162,172,173,175]. A lack of biofilm-specific biomarkers has made noninvasive detection and diagnosis very difficult [174].

Biofilms are very difficult to treat and can require antibiotic concentration over 32 times that necessary for planktonic bacteria. Even the highest tolerable antibiotic dose can be insufficient [176]. Filler explant may be needed, putting the patient at risk for tissue scarring, deformity, and nerve or structural damage. Minimally biodegradable fillers have higher rates of delayed-onset infection [165].

MRSA is a serious concern because few remaining antibiotics are effective. Vancomycin-resistant S. aureus has also emerged—a potentially incurable infection [174]. In the general U.S. population, 20% are persistently colonized with S. aureus (i.e., carriers) and 2% are MRSA carriers. MRSA carriage among surgical staff (4.5%) and healthcare workers (5%) is higher, and many studies support MRSA transmission from healthcare workers to patients [170,177]. As such, MRSA carriage screening and decolonization of surgical staff and patients can reduce MRSA surgical infections. However, no protocols or data are available on plastic surgeon MRSA carriage, association with filler-site infections, or decolonization [178,179].

Management of biofilm infection consists of oral antibiotics with immunomodulatory and anti-inflammatory efficacy [19,22,143,150]. The first-line choice is a macrolide (e.g., clarithromycin) or a tetracycline (e.g., minocycline or doxycycline) for two weeks. Second-line therapy is dual macrolide- and tetracycline-class therapy. The addition of a quinolone (e.g., ciprofloxacin) is reserved as third-line therapy due to potential serious class-wide adverse events. Patients with systemic symptoms or more severe local infection may require hospitalization and IV antibiotics.

Additional treatment options include hyaluronidase, laser, surgical drainage of the abscess, and filler excision. Note that intralesional hyaluronidase requires extreme caution, as it can facilitate the spread of active infection into adjacent tissues.

Another strategy for treating biofilm is low-dose triamcinolone injection mixed with 5-fluorouracil at regular intervals until resolution. The efficacy of 5-fluorouracil may involve its interaction with ariR, a regulatory gene that inhibits biofilm formation [34].

12. CONCLUSION

The importance for primary care clinicians to understand aesthetic medicine, patient variables, and market factors is brought to light by the increasing rates of aesthetic injections performed by non-board-certified physicians, nurses, and minimally trained aestheticians at inadequately equipped clinics, office settings, and spas [20]. Primary care providers are well-placed to importantly inform their patients about many aspects related to aesthetic medicine but benefit from educational intervention to become most effective in this role.

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Evidence-Based Practice Recommendations Citations

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