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 Maupome, Christina M. Gullion, Jack F. Hollis, John J. Snyder, Jeffrey L. Fellows, Reesa L. Laws, B. Alexander White

Research output: Contribution to journalArticle

8 Citations (Scopus)

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.

Original languageEnglish (US)
Article number23
JournalBMC Oral Health
Volume10
Issue number1
DOIs
StatePublished - Oct 5 2010

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Chlorhexidine
Tooth
Randomized Controlled Trials
Placebos
Tooth Loss
Deciduous Tooth
North American Indians
Dental Caries
Vulnerable Populations
United States Food and Drug Administration
Anti-Infective Agents
Population
Cost-Benefit Analysis
Therapeutics

ASJC Scopus subject areas

  • Dentistry(all)

Cite this

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. / Vollmer, William M.; Papas, Athena S.; Bader, James D.; Maupome, Gerardo; Gullion, Christina M.; Hollis, Jack F.; Snyder, John J.; Fellows, Jeffrey L.; Laws, Reesa L.; White, B. Alexander.

In: BMC Oral Health, Vol. 10, No. 1, 23, 05.10.2010.

Research output: Contribution to journalArticle

Vollmer, William M. ; Papas, Athena S. ; Bader, James D. ; Maupome, Gerardo ; Gullion, Christina M. ; Hollis, Jack F. ; Snyder, John J. ; Fellows, Jeffrey L. ; Laws, Reesa L. ; White, B. Alexander. / 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. In: BMC Oral Health. 2010 ; Vol. 10, No. 1.
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