Phase III Trial Shows Silver Diamine Fluoride Halts Cavities in Over Half of Young Children Without Drilling
Key Insights
A large U.S. Phase III trial of 830 children under age six found that 38% silver diamine fluoride (SDF) applied every six months successfully arrested tooth decay (search) in more than half of affected baby teeth.
The noninvasive liquid treatment requires no drilling, injections, or anesthesia and was shown to be safe even in children as young as one year old.
Findings published in JAMA Pediatrics provide the rigorous evidence needed to support an FDA application for SDF as a cavity treatment, potentially expanding insurance coverage and clinical adoption.
A landmark Phase III clinical trial has demonstrated that silver diamine fluoride (SDF), an inexpensive liquid painted directly onto decayed teeth, can halt cavity progression in young children without the need for drilling, injections, or anesthesia. The findings, published in JAMA Pediatrics, represent the strongest evidence to date supporting the safety and efficacy of SDF and may pave the way for full regulatory approval by the U.S. Food and Drug Administration.
The trial, led by researchers at the University of Michigan School of Dentistry (search), enrolled 830 children younger than six years old from dental offices, pediatric medical practices, and Head Start programs across Michigan, New York, and Iowa. Investigators evaluated whether applying a 38% concentration of SDF at six-month intervals could arrest active tooth decay (search) in primary teeth. The study spanned from October 2018 through April 2023.
Results showed that the treatment successfully stopped decay in more than half of affected baby teeth, offering a noninvasive alternative to conventional restorative procedures that typically require removal of decayed tooth material followed by filling placement.
Safety and Efficacy in the Youngest Patients
Lead investigator Margherita Fontana, a professor of dentistry at the University of Michigan School of Dentistry (search), emphasized the treatment's broad applicability. "This is a very effective and safe treatment — even in children as young as one," Fontana said in a statement. That finding carries particular weight given that tooth decay (search) remains the most common chronic disease affecting children in the United States, with more than 40% experiencing cavities. Left untreated, those cavities can lead to severe pain, infections, difficulty eating or sleeping, missed school days, and emergency hospital visits.
The application process involves painting the liquid onto the cavity using a small sponge-tipped applicator, eliminating barriers associated with traditional dental care such as fear of drills and the need for sedation. One notable drawback is that the decayed portion of the tooth permanently turns dark after treatment.
A Path Toward FDA Approval and Broader Access
SDF has been used successfully outside the U.S. for decades and off-label domestically since 2014, but the rigorous trials required for regulatory approval had not been conducted until now. "From a public health perspective, if we want broader implementation across the United States, including in medical settings, we need carefully collected data in U.S. populations, and we now have that," Fontana said.
Amr Moursi, a professor of pediatric dentistry at New York University College of Dentistry (search) and co-author of the study, noted that the trial results support approval from the FDA. If approved, experts believe insurers may be more willing to cover the therapy, healthcare providers could adopt it more widely, and more children could receive treatment before cavities become painful or require surgical intervention.
The treatment is relatively affordable, typically ranging from $20 to $75 per application, according to the Dental Clinics of Texas.
Implications Across Age Groups
Researchers believe SDF could transform care for patients who struggle with conventional dental treatment, including toddlers, older adults, people with developmental or physical disabilities, individuals with severe dental anxiety, and those with limited access to dentists. For children, repeated applications may preserve baby teeth until they naturally fall out. For adults, the treatment could serve as either long-term cavity management or temporary protection before restorative dental work becomes possible.
"For almost anyone, this can arrest the decay and stop the infection and the pain it causes," Fontana said. "This could benefit many people."