Pharmacokinetics of 38 Percent Silver Diamine Fluoride in Children.

Abstract

Purpose: The purpose of this study was to measure serum levels and characterize the pharmacokinetics of silver and fluoride in healthy children receiving silver diamine fluoride (SDF) treatment for dental caries lesions.

Methods: Children (three to 13 years old with at least one caries lesion) were recruited at the University of California, San Francisco Pediatric Dental Clinic from August 2019 through March 2020. Blood was obtained at one randomly selected timepoint up to 168 hours after SDF application. Serum fluoride and silver were measured, and population pharmacokinetic modeling was used to estimate pharmacokinetic parameters and simulate silver concentration versus time profiles in cohorts of children (15 to 50 kg).

Results: Fifty-five children completed the study. Serum fluoride had no discernable temporal pattern. Silver concentra- tions were best described by a one-compartment model with first-order absorption and elimination, and weight as a covariate. Simulated 15 kg children had higher predicted peak silver concentrations than simulated 50 kg children (22.0 ng/mL [95 percent confidence interval {95 percent CI} equals 19.4 to 24.6] versus 12.8 ng/mL [95 percent CI equals 11.3 to 14.3]), and a longer predicted silver half-life (15.5 days [95 percent CI equals 12.5 to 18.5] versus 4.0 days [95 percent CI equals 2.7 to 5.3]).

Conclusions: Evidence presented indicate that topical silver diamine fluoride application in children is safe, and serum concentrations of fluoride and silver pose little risk of toxicity.