Fluoride Administered and Retained After Topical Fluoride Varnish
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 5/9/2018 |
| Start Date: | December 2011 |
| End Date: | December 2013 |
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.
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.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
