Fluoride Administered and Retained After Topical Fluoride Varnish

University of Washington

Status and phase

Completed

Early Phase 1

Conditions

Healthy

Treatments

Device: Fluoride varnish

Study type

Interventional

Funder types

Other

Identifiers

NCT01754831

41117

Details and patient eligibility

About

The specific aim of the study is to determine the excess urinary fluoride and its time course after administration of an application of Premier Enamel Pro Varnish to the teeth of 12-15 month old infants. From these data the investigators can estimate the bioavailable (more precisely the equivalent) dose of sodium fluoride and the peak serum fluoride concentration that will allow an estimate of the margin of safety of the procedure.

Full description

Fluoride varnish painted on the teeth is the standard method dentists use to prevent tooth decay (cavities) in preschool children in the United States. Fluoride varnish is not FDA approved specifically for prevention of cavities, but dentists may legally use it for this purpose. We want to study how much fluoride appears in the urine after the painting procedure to improve our knowledge of how the varnish works and its safety. The fluoride varnish is being used for research purposes for this study by permission of FDA (IND #110869).

Premier Dental Product Company's Enamel Pro Varnish will be used. Up to six children aged 12-15 months will be enrolled in this study. We measured urinary fluoride for 5 hours after application of fluoride varnish to teeth. Baseline levels were measured on a separate day.

Enrollment

6 patients

Sex

All

Ages

12 to 15 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

consent obtained from parent or legal guardian of participant
children aged 12 - 15 months
at least 1 erupted tooth
in general good health

Exclusion criteria

known allergy to any drug, latex, nuts, or resin components or components of toothpaste/dental prophylaxis product
participant has stomatitis or other oral conditions that preclude applying fluoride varnish comfortably