
A phase 3 clinical trial of 830 children aged 12 to 71 months found that 38% silver diamine fluoride effectively arrested active cavitated dentin lesions in primary teeth.
The study, published in JAMA Pediatrics, reported that a single application arrested 54% of lesions at six months, compared to 22.5% in the placebo group.
While the FDA granted silver diamine fluoride Breakthrough Therapy designation in 2016, its use for caries arrest in children remains off-label despite the trial's findings of clinically meaningful efficacy.