Silver diamine fluoride stops tooth decay in children without drilling in major U.S. trial
A major U.S. clinical trial has found that silver diamine fluoride (SDF) can stop tooth decay in more than half of affected baby teeth without drilling. The study, involving 830 children, provides key evidence for FDA approval of SDF as a drug for cavities. The treatment, which darkens the decayed tooth area, could expand access to care for young children and other vulnerable populations.
Silver diamine fluoride treatment
▪A visible drawback of SDF treatment is that the silver permanently turns the decayed part of the tooth dark.
▪In the U.S., dentists have used SDF off-label since 2014, when it was approved as a medical device for reducing tooth sensitivity.
▪Silver diamine fluoride (SDF) is a liquid applied directly to a cavity with a sponge-tipped applicator in a process that takes a few seconds per tooth.
▪The SDF treatment can stop tooth decay without requiring drilling, injections, or sedation.
Phase III clinical trial
▪A Phase III clinical trial led by the University of Michigan provided data on the safety and effectiveness of SDF for treating cavities.
▪The trial found that 38% SDF stopped tooth decay in more than half of affected baby teeth when applied every six months.
▪The research began in 2018 and was supported by over $12 million from the NIH's National Institute of Dental and Craniofacial Research.
▪The study, published in JAMA Pediatrics, included 830 children younger than age 6 from Michigan, New York, and Iowa.
Childhood tooth decay impact
▪Untreated cavities in young children can cause pain and infections, leading thousands to visit emergency departments each year.
▪Tooth decay is the most common chronic disease among children in the United States, affecting more than 40% of them.
FDA approval pathway
▪The clinical trial generated the evidence needed for the manufacturer to submit a drug application to the FDA to use SDF for dental caries.
▪FDA approval of SDF for treating tooth decay could increase its use by providers, enhance insurance payments, and ensure consistent product quality.
Access for vulnerable populations
▪For some children, repeated SDF application can control a cavity until the baby tooth falls out naturally.
▪SDF could be particularly useful for very young children, older adults, people with disabilities, and patients with severe dental anxiety.
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