title: Fluoride varnish efficacy in preventing early childhood caries.
abstract: To determine the efficacy of fluoride varnish (5% NaF, Duraphat, Colgate) added to caregiver counseling to prevent early childhood caries, we conducted a two-year randomized, dental-examiner-masked clinical trial. Initially, 376 caries-free children, from low-income Chinese or Hispanic San Francisco families, were enrolled (mean age +/- standard deviation, 1.8 +/- 0.6 yrs). All families received counseling, and children were randomized to the following groups: no fluoride varnish, fluoride varnish once/year, or fluoride varnish twice/year. An unexpected protocol deviation resulted in some children receiving less active fluoride varnish than assigned. Intent-to-treat analyses showed a fluoride varnish protective effect in caries incidence, p < 0.01. Analyzing the number of actual, active fluoride varnish applications received resulted in a dose-response effect, p < 0.01. Caries incidence was higher for 'counseling only' vs. 'counseling + fluoride varnish assigned once/year' (OR = 2.20, 95% CI 1.19-4.08) and 'twice/year' (OR = 3.77, 95% CI 1.88-7.58). No related adverse events were reported. Fluoride varnish added to caregiver counseling is efficacious in reducing early childhood caries incidence.
authors.affiliation: Center to Address Disparities in Children's Oral Health and Comprehensive Oral Health Research Center of Discovery, University of California, San Francisco School of Dentistry, San Francisco, CA 94143-1361, USA. Jane.Weintraub@ucsf.edu
authors.forename: J A
authors.initials: JA
authors.lastname: Weintraub
authors.forename: F
authors.initials: F
authors.lastname: Ramos-Gomez
authors.forename: B
authors.initials: B
authors.lastname: Jue
authors.forename: S
authors.initials: S
authors.lastname: Shain
authors.forename: C I
authors.initials: CI
authors.lastname: Hoover
authors.forename: J D B
authors.initials: JD
authors.lastname: Featherstone
authors.forename: S A
authors.initials: SA
authors.lastname: Gansky
mesh_terms: D002327:Cariostatic Agents / Q000008:administration & dosage*; D002675:Child, Preschool; D004245:DMF Index; D003731:Dental Caries / Q000517:prevention & control*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005460:Fluorides, Topical; D006267:Health Education, Dental; D006801:Humans; D007223:Infant; D016014:Linear Models; D008297:Male; D016037:Single-Blind Method; D012969:Sodium Fluoride / Q000008:administration & dosage*; D018709:Statistics, Nonparametric
chemical_list: D002327:Cariostatic Agents; D005460:Fluorides, Topical; C023807:sodium fluoride topical preparation; D012969:Sodium Fluoride