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

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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.

Original languageEnglish (US)
Article number23
JournalBMC Oral Health
Issue number1
StatePublished - Oct 5 2010


ASJC Scopus subject areas

  • Dentistry(all)

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