Fluoride Administered and Retained After Topical Fluoride Varnish

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Fluoride Administered and Retained After Topical Fluoride Varnish

Conditions
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Healthy

Intervention / Treatment
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* Device: Fluoride varnish


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 15 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Fluoride varnish<br>Topical fluoride | Device: Fluoride varnish<br>* Topical application of fluoride varnish on present teeth<br>* Other names: Premier Enamel Pro;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinalysis for fluoride levels | 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. | 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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children, fluoride varnish