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American Academy of Pediatrics
Case Report

Pharmacokinetics of Fluoride in Toddlers After Application of 5% Sodium Fluoride Dental Varnish

Peter Milgrom, Donald M. Taves, Amy S. Kim, Gene E. Watson and Jeremy A. Horst
Pediatrics September 2014, 134 (3) e870-e874; DOI: https://doi.org/10.1542/peds.2013-3501
Peter Milgrom
aDepartment of Oral Health Sciences, University of Washington, Seattle, Washington;
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Donald M. Taves
aDepartment of Oral Health Sciences, University of Washington, Seattle, Washington;
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Amy S. Kim
aDepartment of Oral Health Sciences, University of Washington, Seattle, Washington;
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Gene E. Watson
bDepartment of Dentistry, University of Rochester, Rochester, New York; and
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Jeremy A. Horst
cDepartment of Orofacial Sciences, University of California San Francisco, San Francisco, California
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Abstract

The prevalence of dental caries (tooth decay) among preschool children is increasing, driven partially by an earlier age of onset of carious lesions. The American Academy of Pediatrics recommends application of 5% sodium fluoride varnish at intervals increasing with caries risk status, as soon as teeth are present. However, the varnishes are marketed for treatment of tooth sensitivity and are regulated as medical devices rather than approved by the US Food and Drug Administration for prevention of dental caries (tooth decay). The objective of this research is to examine the safety of use in toddlers by characterizing the absorption and distribution profile of a currently marketed fluoride varnish. We measured urinary fluoride for 5 hours after application of fluoride varnish to teeth in 6 toddlers aged 12 to 15 months. Baseline levels were measured on a separate day. The urine was extracted from disposable diapers, measured by rapid diffusion, and extrapolated to plasma levels. The mean estimated plasma fluoride concentration was 13 μg/L (SD, 9 μg/L) during the baseline visit and 21 μg/L (SD, 8 μg/L) during the 5 hours after treatment. Mean estimated peak plasma fluoride after treatment was 57 μg/L (SD, 22 μg/L), and 20 μg/kg (SD, 4 μg/L) was retained on average. Retained fluoride was 253 times lower than the acute toxic dose of 5 mg/kg. Mean plasma fluoride after placement of varnish was within an SD of control levels. Occasional application of fluoride varnish following American Academy of Pediatrics guidance is safe for toddlers.

  • fluorides
  • fluoride varnishes
  • pharmacokinetics
  • drug safety
  • toddler
  • Accepted February 19, 2014.
  • Copyright © 2014 by the American Academy of Pediatrics

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Pediatrics
Vol. 134, Issue 3
1 Sep 2014
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Pharmacokinetics of Fluoride in Toddlers After Application of 5% Sodium Fluoride Dental Varnish
Peter Milgrom, Donald M. Taves, Amy S. Kim, Gene E. Watson, Jeremy A. Horst
Pediatrics Sep 2014, 134 (3) e870-e874; DOI: 10.1542/peds.2013-3501

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Pharmacokinetics of Fluoride in Toddlers After Application of 5% Sodium Fluoride Dental Varnish
Peter Milgrom, Donald M. Taves, Amy S. Kim, Gene E. Watson, Jeremy A. Horst
Pediatrics Sep 2014, 134 (3) e870-e874; DOI: 10.1542/peds.2013-3501
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