Michigan Trial Shows 38% Liquid Fluoride Halves Cavity Progression in Children, Bolstering FDA Approval
Updated
Updated · Gizmodo · Aug 3
Michigan Trial Shows 38% Liquid Fluoride Halves Cavity Progression in Children, Bolstering FDA Approval
3 articles · Updated · Gizmodo · Aug 3
Summary
830 children under 6 with severe early childhood cavities were enrolled in a Phase III trial, where silver diamine fluoride outperformed placebo at stopping further decay.
At 8 months, about 50% of children given the 38% liquid fluoride showed no cavity progression, versus 17% in the placebo group, after treatment at enrollment and again six months later.
Reported adverse events were similar across both groups, though the treatment permanently darkens treated teeth — a tradeoff researchers said may matter less for baby teeth.
The University of Michigan team said the NIH-backed results provide the rigorous U.S. safety and efficacy evidence needed to support FDA approval of silver diamine fluoride for cavities, a use now limited to off-label treatment.
More than 40% of U.S. children develop tooth decay, and researchers said a noninvasive option could reduce reliance on fillings, surgery and other harder-to-access dental care.