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Large U.S. Trial Finds Silver Diamine Fluoride Stops Many Cavities in Young Children

The Phase III results strengthen the case for FDA review because the quick, low-cost topical treatment arrested far more lesions than placebo in a high-risk pediatric group.

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The clinical trial began in 2018 and included researchers from the University of Michigan, New York University, the University of Iowa, and Indiana University | Representative Image
A drill-free silver diamine fluoride treatment can quickly stop childhood tooth decay

Overview

  • The multisite Phase III trial, published in late July, randomized 830 children ages 12 to 71 months and found a single 38% silver diamine fluoride application arrested about 50–57% of eligible cavitated dentin lesions at 3–8 months versus roughly 17–23% for placebo.
  • Overall rates of reported adverse events were similar between groups but four severe events occurred only in the SDF arm and treated lesions became permanently darkened from the silver.
  • Study limits that matter for regulators include an eight-month maximum follow-up, about 30% participant drop‑out, possible loss of blinding from staining, exclusion of children with pain or infection, and early stopping after an interim analysis.
  • Investigators say the results provide U.S. efficacy data to support FDA consideration of a drug indication and could, if approved, expand noninvasive, lower‑cost care and reduce the need for fillings and treatment under general anesthesia for underserved children.
  • SDF has been used off‑label in the U.S. since a 2014 clearance for tooth sensitivity and was added to the WHO Essential Medicines list in 2021, and this NIDCR‑funded trial was designed specifically to inform U.S. regulatory and clinical use decisions.