- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01754831
Fluoride Administered and Retained After Topical Fluoride Varnish
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98115
- UW Center for Pediatric Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Fluoride varnish
Topical fluoride
|
Topical application of fluoride varnish on present teeth
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 41117
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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