Fluoride Administered and Retained After Topical Fluoride Varnish
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
|Official Title:||Fluoride Administered and Retained After Topical Fluoride Varnish|
- Urinalysis for fluoride levels [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Experimental: Varnish fluoride
Intervention of applying fluoride varnish to existing teeth
Device: Fluoride varnish
Topical application of fluoride varnish on present teeth
Other Name: Premier Enamel Pro
No Intervention: Control
No topical application of fluoride varnish
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. The participants will have two study visits, Arm 1 (fluoride varnish topical application) and Arm 2 (control, no intervention). For both Arms of the study, 5 hours of urine collection will occur.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01754831
|United States, Washington|
|UW Center for Pediatric Dentistry|
|Seattle, Washington, United States, 98115|
|Principal Investigator:||Peter Milgrom, DDS||University of Washington|