Fluoride Administered and Retained After Topical Fluoride Varnish

Completed · Early Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01754831

Run by

University of Washington

People needed

6

Starts

2011-12-01

Expected to finish

2013-12-01

Last updated by the study team

2018-05-07

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• UW Center for Pediatric Dentistry — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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