Untreated cavities send thousands of young children in the United States to emergency departments each year. Because hospital doctors generally cannot repair the underlying dental problem, some children continue to suffer from pain and infection, while others eventually need surgery under general anesthesia.
A low-cost liquid known as silver diamine fluoride, or SDF, may offer a much simpler option. Dentists apply it directly to a cavity with a small sponge-tipped applicator, a process that takes just a few seconds for each tooth. The treatment can stop cavities without the need for drilling, injections or sedation.
Long-Used Treatment Gets Stronger Evidence
SDF has been used successfully in many countries for decades. In the United States, dentists have used it without authorization since 2014, when it was approved as a medical device to reduce tooth sensitivity.
However, researchers had not yet completed the large US clinical trials needed to demonstrate its safety and effectiveness as a cavity treatment. That evidence would be needed for the Food and Drug Administration to approve SDF as a drug to treat cavities.
A clinical trial led by the University of Michigan has provided that data.
The Phase III study, published in JAMA Pediatricsincluded 830 children under 6 years of age. Participants were recruited through dental offices, pediatric medical offices, and Head Start and Early Head Start programs in Michigan, New York, and Iowa.
SDF stopped cavities in many baby teeth
The researchers found that 38% of the SDF stopped cavities in more than half of the affected baby teeth when the treatment was applied every six months.
Traditional cavity treatment usually involves removing damaged tooth material and placing a filling. SDF does not require tooth extraction. Instead, the liquid is painted directly onto the damaged area.
“This is a very effective and safe treatment, even in children as young as one year old,” said Margherita Fontana, professor of dentistry at the University of Michigan School of Dentistry and principal investigator of the study.
Tooth decay is the most common chronic disease among children, affecting more than 40% of children in the United States. Untreated cavities can lead to severe pain, infections, difficulty sleeping or eating, missed school days, and repeated doctor appointments.
A potential option for difficult-to-treat patients
Fontana said SDF could be particularly useful for very young children, older adults, people with physical or developmental disabilities, and patients with severe dental anxiety. It can also help people who have limited access to conventional dental care or who cannot easily tolerate standard procedures.
The treatment has a visible drawback. The silver permanently darkens the decayed part of the tooth.
“If we want more children and families to benefit from this treatment, we need rigorous evidence showing that it works and that it is safe. From a public health perspective, if we want broader implementation across the United States, including in medical settings, we need carefully collected data in US populations, and now we have it,” Fontana said.
The research began in 2018 and continued despite disruptions caused by the COVID-19 pandemic.
“In medicine, doctors want high-quality evidence before changing practice,” Fontana said. “It’s important to have data they can refer to because young children often visit pediatricians years before visiting the dentist; broader acceptance could allow many more cavities to be treated while referral to a dentist is successful and before they become painful, infected or require surgery.”
Findings Could Support FDA Approval
Fontana worked with researchers at New York University, the University of Iowa and Indiana University, as well as the NIH’s National Institute of Dental and Craniofacial Research. The institute provided more than $12 million to support the study.
The trial generated the clinical evidence the manufacturer needs to submit a dental caries drug application to the FDA. Elevate Oral Care supplied Advantage Arrest 38% SDF, the product tested in the study.
Amr Moursi, a professor of pediatric dentistry at New York University School of Dentistry, said the findings could help expand access to treatment.
“Our results support FDA approval of SDF to control the arrest of dental cavities in young children. Removing SDF from off-label status would be an important innovation that could lead to increased utilization by providers, improved payments by insurers, and more consistent product quality,” said Moursi, co-principal investigator of the study.
A bridge or long-term treatment
For some children, reapplying SDF every few months can control cavities until the baby tooth falls out naturally. In adults, it could work as a long-term treatment or provide temporary protection until a restorative procedure is affordable or practical.
“For almost anyone, this can stop the decay and stop the infection and the pain it causes,” Fontana said. “This could benefit a lot of people.”