Fluoride Administered and Retained After Topical Fluoride Varnish
|ClinicalTrials.gov Identifier: NCT01754831|
Recruitment Status : Unknown
Verified December 2012 by University of Washington.
Recruitment status was: Active, not recruiting
First Posted : December 21, 2012
Last Update Posted : December 21, 2012
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Device: Fluoride varnish||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fluoride Administered and Retained After Topical Fluoride Varnish|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||March 2013|
|Estimated Study Completion Date :||December 2013|
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
- Urinalysis for fluoride levels [ Time Frame: 2 days ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01754831
|United States, Washington|
|UW Center for Pediatric Dentistry|
|Seattle, Washington, United States, 98115|
|Principal Investigator:||Peter Milgrom, DDS||University of Washington|