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Completed

NCT Number: NCT01754831

Fluoride Administered and Retained After Topical Fluoride Varnish

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.

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Key information

Conditions

Healthy

Age range

12 month–15 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

UW Center for Pediatric Dentistry

Seattle, Washington, 98115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluoride varnish

Device

Topical application of fluoride varnish on present teeth

Other names: Premier Enamel Pro

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 21, 2012
Registry last updated
May 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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