12.6 New or Experimental Treatments, Monitoring Patient Reactions, and Reporting Adverse Events
Key Takeaways
California B&P § 651(b)(7) makes a scientific claim misleading if it cannot be supported by reliable, peer-reviewed, published studies.
ADA Advisory Opinion 5.D.2 requires dentists to verify a health product's safety and efficacy claims independently, not rely on the manufacturer.
California requires an experimental subject's bill of rights and a signed, dated written consent before a medical experiment (Health and Safety Code §§ 24172–24173).
ADA Advisory Opinion 5.D.1 obliges a dentist who suspects an adverse reaction to a drug or device to tell the medical and dental community, including the FDA for serious events.
California Civil Code § 56.10(c)(14) permits disclosing patient information when voluntarily reporting drug or device adverse events to the FDA.
Evaluating new or experimental treatment (K2171)
A dentist considering a new laser protocol, a novel implant surface, a "biomimetic" material, or an off-label use should apply clear criteria:
| Criterion | Question to ask | Source |
|---|---|---|
| Evidence | Is there reliable, peer-reviewed, published research, ideally systematic reviews or controlled trials, rather than case reports or testimonials? | B&P § 651(b)(7); ADA 5.A.2 |
| Independent verification | Have I checked the manufacturer's claims myself, not just accepted their marketing? | ADA 5.D.2 |
| Regulatory status | Is the device FDA-cleared or approved for this use? Is the use off-label, and is that disclosed? | FDA; veracity |
| Transparency | Are the complete formulae available to the profession, and am I avoiding claims of exclusive or secret methods? | ADA 5.D |
| Competence | Have I completed adequate training, and can I manage complications? | ADA 2.A; CDA competence |
| Consent | Have I told the patient the treatment is new or experimental, what the evidence shows, the risks and unknowns, and the established alternatives? | Cobbs; CDA 1D |
| Conflicts | Do I have a financial interest to disclose? | ADA 5.C, 5.D.2 |
ADA Section 5.D requires dentists, except in formal investigative studies, to prescribe, dispense, or promote only devices, drugs, and agents whose complete formulae are available to the profession, and not to hold out any device or technique as exclusive if that would be misleading. Advisory Opinion 5.A.2 calls it unethical to claim a treatment can diagnose, cure, or relieve conditions without accepted scientific support.
Formal research
When a treatment is part of a medical experiment, California's Protection of Human Subjects in Medical Experimentation Act requires:
- An experimental subject's bill of rights, in a language the subject speaks fluently, covering the purpose, procedures, discomforts and risks, expected benefits, alternatives, treatment available if complications arise, the chance to ask questions, the right to withdraw at any time without prejudice, a copy of the signed consent, and a decision free of coercion (Health and Safety Code § 24172).
- A written consent form, signed and dated by the subject or legal representative (§ 24173).
The CDA Code (Section 1D) likewise requires informed consent before using a human subject in research. ADA Section 3.C obliges dentists to share useful research results with the profession.
Evaluating patient reactions (K2174)
Monitoring does not end when the patient leaves the chair. Evaluate reactions systematically:
- Baseline: record allergies, including latex, local anesthetics, metals, acrylics, and medications, along with current drugs and relevant conditions.
- During treatment: watch vital signs and responses, especially with anesthetics, sedation, and new materials.
- Afterward: follow up after surgery, new prescriptions, or new materials by phone or recall, and ask specifically about symptoms.
- Assess causation: timing, dose, prior exposure, whether symptoms improve when the agent is removed, and other possible causes.
- Classify severity: expected side effect, such as mild post-operative sensitivity; allergic reaction, such as a mucosal lichenoid reaction to a metal; or serious adverse event, such as anaphylaxis, hospitalization, permanent nerve injury, or death.
- Act: treat or refer, change the plan, document in the chart, update the allergy list, and inform the patient.
Reporting adverse reactions (T211, K2111)
ADA Advisory Opinion 5.D.1:
A dentist who suspects the occurrence of an adverse reaction to a drug or dental device has an obligation to communicate that information to the broader medical and dental community, including, in the case of a serious adverse event, the Food and Drug Administration (FDA).
Ways to meet it:
- FDA MedWatch: voluntary reports by health professionals of serious adverse events, product problems, and device malfunctions. Civil Code § 56.10(c)(14) expressly permits disclosing medical information for voluntary FDA reports.
- Vaccine Adverse Event Reporting System (VAERS): for dentists who give influenza or COVID-19 vaccines (Section 7.1), report clinically significant adverse events after vaccination.
- The manufacturer: so it can investigate and meet its own FDA reporting duties.
- Colleagues: case reports, study clubs, and dental society channels, with patient identity protected.
- The Dental Board, when the law requires it: a patient's death, or a hospital or emergency transfer (always, for sedated patients), must be reported within seven days (B&P § 1680(z)). This is a legal report, separate from the ethical duty to inform the community.
Worked scenario
Three patients develop persistent, unusual gingival inflammation around restorations placed with a newly marketed resin cement. Symptoms improve after the restorations are replaced with a different cement.
- Evaluate each case, document the timeline and response, and tell the patients what was found.
- Stop using the product pending review.
- Report to the manufacturer and file an FDA MedWatch report (ADA 5.D.1). If a reaction is serious, the FDA report is expressly expected.
- Share the observation with colleagues through appropriate professional channels, without identifying patients.
A dentist suspects that a new dental adhesive caused a serious allergic reaction requiring emergency treatment. Under ADA Advisory Opinion 5.D.1, what should the dentist do?
Keep the information private to avoid liability
Report only if a second patient has the same reaction
Communicate the adverse reaction to the broader medical and dental community, including a report to the FDA because it was serious
Tell only the patient's physician
A sales representative says a new "regenerative" gel reverses periodontitis and gives the dentist a brochure of testimonials. What does the ADA Code expect before the dentist recommends it?
Accept the claims because the product is sold by a licensed company
Recommend it as an exclusive technique to attract new patients
Use it without telling patients it is new, to avoid alarming them
Independently verify the claims against accepted scientific research, and not rely on the manufacturer's representations
A dentist enrolls patients in a study testing an unapproved bone-graft material. What does California law require before a patient participates?
A copy of the experimental subject's bill of rights and a written consent form signed and dated by the subject or their representative
Only verbal consent documented in the chart
Approval from the Dental Board for each patient
Nothing, if the material is provided free of charge
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