Abstract
Design
Randomised controlled trial in two community health centres.
Intervention
All families received counselling, and children were randomised to the following groups: no fluoride varnish, fluoride varnish once a year, or fluoride varnish twice a year. Due to an unexpected protocol variation children unintentionally received a placebo varnish instead of the active product during a 10-month period. Consequentially only one child received all four planned active applications.
Outcome measure
The primary outcome measure was dental caries assessed by one dentist masked to treatment group. Two-year follow-up was planned unless caries were detected at the 1-year follow-up examination, in which case children were considered treatment failures and referred for dental care.
Results
A total of 376 children were randomised with a mean age of 1.8 years of whom 71% were examined at year 1 and 67% at year 2. Intent-to-treat analyses showed a fluoride varnish protective effect in caries incidence, P < 0.01. Analysing the number of actual, active fluoride varnish applications received resulted in a dose-response effect, P < 0.01. Caries incidence was higher for counselling only vs ‘counselling + fluoride varnish assigned once/year’ (odds ratio, 2.20; 95% confidence interval 1.19–4.08) and ‘twice/year’ (odds ratio, 3.77; 95% confidence interval 1.88–7.58). No related adverse events were reported.
Conclusions
Fluoride varnish and parental counselling should be recommended as part of caries prevention programmes targeting infants and toddlers.
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Change history
06 July 2018
This article was initially published with an incorrect DOI. A new DOI has been assigned and registered at Crossref, and has been corrected in the article.
References
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Authors and Affiliations
Additional information
Address for correspondence: Dr J Weintraub, 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, 3333 California Street, Suite 495, San Francisco, CA 94143-1361, USA.
Weintraub JA, Ramos-Gomez F, Jue B et al. Fluoride varnish efficacy in preventing early childhood caries. J Dent Res. 2006; 85:172–176
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Richards, D. Fluoride varnish should be part of caries prevention programmes. Evid Based Dent 7, 65–66 (2006). https://doi.org/10.1038/sj.ebd.6400123x
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DOI: https://doi.org/10.1038/sj.ebd.6400123x
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