Every year, countless young children in the United States end up in emergency rooms due to untreated cavities. Unfortunately, hospital staff typically can’t fix the underlying dental issues, leaving some kids in ongoing pain and infection, while others may need surgery under general anesthesia eventually.
A promising solution could be a low-cost liquid called silver diamine fluoride, or SDF. It’s applied directly to the cavity with a small sponge-tipped applicator and takes mere seconds per tooth. Remarkably, this treatment halts decay without the need for drilling, injections, or sedation.
A Long-Used Treatment Gains Stronger Evidence
SDF has been successfully utilized in various countries for decades. In the U.S., dentists have been using it off-label since 2014, following its approval as a medical device aimed at reducing tooth sensitivity.
However, until now, larger clinical trials in the U.S. had not been completed to verify its safety and efficacy as a treatment for cavities, which is necessary for the Food and Drug Administration to officially approve it for tooth decay.
A clinical trial spearheaded by the University of Michigan has now provided that crucial data.
The Phase III study, published in JAMA Pediatrics, involved 830 children under the age of 6, recruited from dental offices, pediatric practices, and Head Start programs in Michigan, New York, and Iowa.
SDF Stopped Decay in Many Baby Teeth
The research discovered that 38% of the time, SDF halted tooth decay in over half of the affected baby teeth when applied every six months. Traditional cavity treatments usually entail removing the damaged parts of a tooth and placing a filling. In contrast, SDF simply involves painting the solution on the decayed area.
“This is a very effective and safe treatment—even for children as young as 1,” said Margherita Fontana, a professor of dentistry and the study’s lead investigator.
Tooth decay is the most prevalent chronic disease among kids, impacting more than 40% of children in the U.S. Untreated cavities can cause severe pain, infections, trouble sleeping or eating, missed school days, and frequent medical appointments.
A Potential Option for Hard-to-Treat Patients
Fontana mentioned that SDF could be particularly beneficial for very young children, older adults, individuals with developmental or physical disabilities, and those with significant dental anxiety. It might also serve people who have limited access to standard dental care or struggle to tolerate conventional procedures.
However, there is a noticeable downside: the silver permanently darkens the decayed portion of the tooth.
“For more children and families to benefit from this treatment, we need robust evidence showing both its effectiveness and safety. If we aim for wider implementation across the U.S., especially in medical settings, we require well-collected data from U.S. populations, and we’ve achieved that,” Fontana noted.
The study began in 2018, continuing even amid disruptions from the COVID-19 pandemic.
“In medicine, practitioners prefer high-quality evidence before changing their practices,” Fontana explained. “Having reliable data is essential because young children often see pediatricians long before they visit a dentist; broader acceptance could allow for more early treatments of cavities before they turn painful, infected, or require surgery.”
Findings Could Support FDA Approval
Fontana collaborated with researchers from New York University, the University of Iowa, and Indiana University, alongside the NIH’s National Institute of Dental and Craniofacial Research, which provided significant funding for the study.
The trial produced the necessary clinical evidence for the manufacturer to submit a request to the FDA for SDF as a dental caries treatment. Elevate Oral Care has provided Advantage Arrest 38% SDF, the product used in the study.
Amr Moursi, a professor of pediatric dentistry at New York University, expressed that the findings could facilitate expanded access to this treatment.
“Our results support FDA approval of SDF for managing tooth decay in young children. Transitioning SDF from off-label to approved status would be a significant advancement, potentially leading to increased use by providers and better reimbursement from insurers,” stated Moursi, a co-principal investigator in the study.
A Bridge or Long-Term Treatment
In some cases, reapplying SDF every few months could manage the cavity until the baby tooth naturally falls out. For adults, it might serve as a long-term solution or offer temporary protection until a more permanent procedure becomes feasible.
“For almost anyone, this can halt decay and alleviate the associated infection and pain,” Fontana concluded. “This could benefit many people.”
