Background: This is a review of the clinical use, cariostatic mechanism, efficacy, safety and toxicity of fluoride varnishes.
Types of studies reviewed: The authors reviewed and summarized in vitro, in vivo and in situ studies; clinical trials; demonstration programs; position papers; and editorials published in English in the biomedical literature since 1966.
Results: Extensive laboratory research and clinical trials conducted in Europe and elsewhere show that fluoride varnishes are as efficacious as other caries-preventive agents. Fluoride varnishes are widely used in European caries-preventive programs. The U.S. Food and Drug Administration has cleared these products only as medical devices to be used as cavity liners and for the treatment of hypersensitive teeth. These products have not yet been cleared for marketing in the United States as caries-preventive agents.
Clinical implications: Three fluoride varnishes are currently available in the United States. Semiannual applications are the most proven treatment regimen. Varnishes are safe and easy to apply and set in contact with intraoral moisture.