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

William M Vollmer, Athena S Papas, James D Bader, Gerardo Maupomé, Christina M Gullion, Jack F Hollis, John J Snyder, Jeffrey L Fellows, Reesa L Laws, B Alexander White, PACS Collaborative Research Group, William M Vollmer, Athena S Papas, James D Bader, Gerardo Maupomé, Christina M Gullion, Jack F Hollis, John J Snyder, Jeffrey L Fellows, Reesa L Laws, B Alexander White, PACS Collaborative Research Group

Abstract

Background: 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.

Methods/design: 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.

Discussion: 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.

Trial registration number: NCT00357877.

Figures

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Figure 1
Sample size needed at varying effect sizes, using normalized Poisson data.

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