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Dental procedures ‘excellent models’ for sedation product evaluation, coalition says

Rockville, Md.—Dental procedures can provide relevant efficacy and safety data as the Food and Drug Administration develops guidance on clinical development programs for sedation products, the ADA and four dental specialty organizations told the FDA.

“A dental perspective would be invaluable to the development of any clinical development program guidance,” the dental coalition said in response to FDA’s request for information related to the clinical development and use of sedation products in adult and pediatric age groups. Also commenting on the FDA plans were the American Academy of Pediatric Dentistry, American Academy of Periodontology, American Association of Oral and Maxillofacial Surgeons and American Society of Dentist Anesthesiologists.

“Dental surgical/restorative procedures are excellent models for the use of sedation drug products and their evaluation,” the coalition said in a July 3 cover letter with the organizations’ comments. “The procedures are short and recovery is such that end-of-procedure responses can be elicited from the patients. Meaningful safety data come from both healthy patients and those who are more susceptible to respiratory complications, particularly children and adolescents.

“Safe and effective sedation products are a critical part of oral health care, especially for patients with special needs and those who suffer from anxiety associated with dental or other medical procedures and conditions,” the coalition said. “We urge you to include dental representatives on any future panels or workgroups that may aid in drafting of industry guidance on the clinical development and use of sedation products in adult and pediatric age groups.”

The cover letter and comments will be posted at the ADA.org Dental Product Regulation page.