A brush-on liquid that takes seconds to apply may give many young children a way to stop cavities without drilling, shots or sedation.
A Phase III clinical trial led by the University of Michigan found 38 percent silver diamine fluoride, or SDF, stopped tooth decay in more than half of affected baby teeth when applied every six months.
The study, published in JAMA Pediatrics, included 830 children younger than 6. Researchers recruited participants through dental offices, pediatric medical practices, and Head Start and Early Head Start programs in Michigan, New York and Iowa.
Untreated cavities send thousands of young children in the United States to emergency departments each year. Hospital doctors usually cannot repair the dental problem, and some children continue to have pain and infection or later need surgery under general anesthesia.
SDF is a low-cost liquid that dentists apply directly to a cavity with a small sponge-tipped applicator. The process takes a few seconds for each tooth and does not require removal of the tooth.
“This is a very effective and safe treatment , even in children as young as 1,” said Margherita Fontana, professor of dentistry at the University of Michigan School of Dentistry and the study’s lead investigator.
Tooth decay affects more than 40 percent of children in the United States and is the most common chronic disease among children. Untreated cavities can lead to intense pain, infections, difficulty sleeping or eating, missed school days and repeated medical appointments.
SDF has been used in many countries for decades. In the United States, dentists have used it off-label since 2014, when it was approved as a medical device for reducing tooth sensitivity.
The trial provides the large U.S. clinical data needed to show safety and effectiveness as a cavity treatment, evidence needed for the Food and Drug Administration to approve SDF as a drug for treating tooth decay.
The treatment has one visible drawback. The silver permanently turns the decayed part of the tooth dark.
“If we want more children and families to benefit from this treatment, we need rigorous evidence showing both that it works and that it’s 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 U.S. populations, and we now have that,” Fontana said.
Fontana said SDF could be particularly useful for very young children, older adults, people with developmental or physical disabilities, and patients with severe dental anxiety. It may also help people who have limited access to conventional dental care or cannot easily tolerate standard procedures.
The research began in 2018 and continued through disruptions caused by the COVID-19 pandemic. Fontana worked with researchers from New York University, the University of Iowa and Indiana University, as well as the NIH’s National Institute of Dental and Craniofacial Research, which 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 percent SDF, the product tested in the study.
“Our results support FDA approval of SDF for managing arrest of tooth decay in young children. Removing SDF from off-label status would be an important innovation which could lead to increased utilization by providers, enhanced payments by insurers and more consistent product quality,” said Amr Moursi, professor of pediatric dentistry at New York University College of Dentistry and a co-principal investigator on the study.
“For almost anyone, this can arrest the decay and stop the infection and the pain it causes,” Fontana said. “This could benefit many people.”
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