No-drill liquid halts baby tooth decay in U.S. trial
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- University of Michigan researchers led a Phase III trial of 830 children under age 6, published in JAMA Pediatrics, finding that 38% silver diamine fluoride halted decay in more than half of treated baby teeth when applied every six months.
- Silver diamine fluoride is brushed onto cavities with a sponge-tipped applicator in seconds, requiring no drilling, injections, or sedation — though it permanently darkens the decayed area.
- The FDA has not approved SDF as a cavity drug; dentists have used it off-label in the US since 2014 only for tooth sensitivity, and the new trial data could now support a manufacturer's drug application.
- Tooth decay affects more than 40% of US children and is the most common chronic childhood disease, sending thousands of untreated cases to emergency departments each year where hospital doctors typically cannot perform the repair.
- NIH's National Institute of Dental and Craniofacial Research provided more than $12 million, with collaborators from NYU, the University of Iowa, and Indiana University contributing to the study that began in 2018.
- Amr Moursi, NYU co-principal investigator, said FDA approval of SDF for cavity arrest could remove its off-label status, enabling broader provider use, insurance payments, and more consistent product quality.
Why it matters: For thousands of young children whose untreated cavities currently send them to ERs, this no-drill, seconds-long liquid could be administered at pediatric visits years before they reach a dental office — but only if the FDA approves it as a cavity drug, a step the trial was designed to enable. The treatment carries a visible trade-off: the decayed tooth permanently darkens.
