title: Efficacy of chlorhexidine varnish for the prevention of adult caries: a randomized trial.
abstract: The Prevention of Adult Caries Study, an NIDCR-funded multicenter, double-blind, randomized clinical trial, enrolled 983 adults (aged 18-80 yrs) at high risk for developing caries (20 or more intact teeth and 2 or more lesions at screening) to test the efficacy of a chlorhexidine diacetate 10% weight per volume (w/v) dental coating (CHX). We excluded participants for whom the study treatment was contraindicated or whose health might affect outcomes or ability to complete the study. Participants were randomly assigned to receive either the CHX coating (n = 490) or a placebo control (n = 493). Coatings were applied weekly for 4 weeks and a fifth time 6 months later. The primary outcome (total net D(1-2)FS increment) was the sum of weighted counts of changes in tooth surface status over 13 months. We observed no significant difference between the two treatment arms in either the intention-to-treat or per-protocol analyses. Analysis of 3 protocol-specified secondary outcomes produced similar findings. This trial failed to find that 10% (w/v) chlorhexidine diacetate coating was superior to placebo coating for the prevention of new caries (Clinicaltrials.gov registration number NCT00357877).
authors.affiliation: Tufts University School of Dental Medicine, Boston, MA 02111, USA.
authors.forename: A S
authors.initials: AS
authors.lastname: Papas
authors.forename: W M
authors.initials: WM
authors.lastname: Vollmer
authors.forename: C M
authors.initials: CM
authors.lastname: Gullion
authors.forename: J
authors.initials: J
authors.lastname: Bader
authors.forename: R
authors.initials: R
authors.lastname: Laws
authors.forename: J
authors.initials: J
authors.lastname: Fellows
authors.forename: J F
authors.initials: JF
authors.lastname: Hollis
authors.forename: G
authors.initials: G
authors.lastname: Maupomé
authors.forename: M L
authors.initials: ML
authors.lastname: Singh
authors.forename: J
authors.initials: J
authors.lastname: Snyder
authors.forename: P
authors.initials: P
authors.lastname: Blanchard
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage*; D002710:Chlorhexidine / Q000008:administration & dosage*; D003442:Crowns; D004245:DMF Index; D003731:Dental Caries / Q000145:classification / Q000517:prevention & control*; D003733:Dental Caries Susceptibility / Q000187:drug effects; D003743:Dental Enamel / Q000187:drug effects / Q000473:pathology; D003793:Dental Restoration, Permanent; D003804:Dentin / Q000187:drug effects / Q000473:pathology; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D017213:Root Caries / Q000517:prevention & control; D016388:Tooth Loss / Q000145:classification; D014092:Tooth Root / Q000187:drug effects / Q000473:pathology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000891:Anti-Infective Agents, Local; D010919:Placebos; D002710:Chlorhexidine