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Fluoride Administered and Retained After Topical Fluoride Varnish

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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
Sponsor:
Information provided by (Responsible Party):
University of Washington

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Device: Fluoride varnish Early Phase 1

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. 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
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 15 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01754831


Locations
United States, Washington
UW Center for Pediatric Dentistry
Seattle, Washington, United States, 98115
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Peter Milgrom, DDS University of Washington

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01754831     History of Changes
Other Study ID Numbers: 41117
First Posted: December 21, 2012    Key Record Dates
Last Update Posted: December 21, 2012
Last Verified: December 2012

Keywords provided by University of Washington:
children
fluoride varnish

Additional relevant MeSH terms:
Fluorides
Fluorides, Topical
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs