Design of the Prevention of Adult Caries Study (PACS): a randomized clinical trial assessing the effect of a chlorhexidine dental coating for the prevention of adult caries

• Published in: BMC oral health Vol. 10; no. 1; p. 23
• Main Authors: Vollmer, William M, Papas, Athena S, Bader, James D, Maupomé, Gerardo, Gullion, Christina M, Hollis, Jack F, Snyder, John J, Fellows, Jeffrey L, Laws, Reesa L, White, B Alexander
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 05.10.2010; BioMed Central; BMC
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Analysis of Variance; Anti-Infective Agents, Local - administration & dosage; Anti-Infective Agents, Local - therapeutic use; Cariostatic Agents - administration & dosage; Cariostatic Agents - therapeutic use; Chlorhexidine; Chlorhexidine - administration & dosage; Chlorhexidine - therapeutic use; Clinical trials; Cost-Benefit Analysis; Dental care; Dental caries; Dental Caries - prevention & control; DMF Index; Dosage and administration; Double-Blind Method; Drug therapy; Fluorides; Health services; Humans; Management; Medical research; Middle Aged; National Institute of Dental and Craniofacial Research (U.S.); Older people; Outcome Assessment (Health Care) - methods; Prevention; Product development; Quality Control; Research Design; Streptococcus mutans - drug effects; Study Protocol; United States; United States Food and Drug Administration; Young Adult; United States
• ISSN: 1472-6831; 1472-6831
• DOI: 10.1186/1472-6831-10-23

Dental caries is one of the primary causes of tooth loss among adults. It is estimated to affect a majority of Americans aged 55 and older, with a disproportionately higher burden in disadvantaged populations. Although a number of treatments are currently in use for caries prevention in adults, evidence for their efficacy and effectiveness is limited. The Prevention of Adult Caries Study (PACS) is a multicenter, placebo-controlled, double-blind, randomized clinical trial of the efficacy of a chlorhexidine (10% w/v) dental coating in preventing adult caries. Participants (n = 983) were recruited from four different dental delivery systems serving four diverse communities, including one American Indian population, and were randomized to receive either chlorhexidine or a placebo treatment. The primary outcome is the net caries increment (including non-cavitated lesions) from baseline to 13 months of follow-up. A cost-effectiveness analysis also will be considered. This new dental treatment, if efficacious and approved for use by the Food and Drug Administration (FDA), would become a new in-office, anti-microbial agent for the prevention of adult caries in the United States. NCT00357877.