Fluoride Administered and Retained After Topical Fluoride Varnish

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01754831
First received: October 10, 2012
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Healthy
Device: Fluoride varnish
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Fluoride Administered and Retained After Topical Fluoride Varnish

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Urinalysis for fluoride levels [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 6
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   12 Months to 15 Months
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01754831     History of Changes
Other Study ID Numbers: 41117
Study First Received: October 10, 2012
Last Updated: December 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Washington:
children
fluoride varnish

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

ClinicalTrials.gov processed this record on July 31, 2014