Researchers led by the University of Michigan have produced compelling evidence that a much simpler approach can stop many cavities from getting worse. Published in JAMA Pediatrics, the Phase III clinical trial included 830 children younger than 6 recruited from dental clinics, pediatric medical practices, and Head Start programs in Michigan, New York, and Iowa.
The results showed that a solution containing 38% silver diamine fluoride successfully stopped decay in more than half of affected baby teeth when applied at six-month intervals. Dentists refer to this as arresting tooth decay, meaning the damaged area stops deteriorating. Unlike a traditional filling, the treatment does not replace lost tooth structure but prevents existing decay from progressing.
SDF works through the combined effects of silver and fluoride. Silver helps combat bacteria associated with tooth decay, while fluoride helps strengthen the mineral structure of teeth and resist further damage.
"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 is the most common chronic disease among children, affecting more than 40% of American children. Untreated decay can lead to severe toothaches, infections, problems eating and sleeping, missed school days, and repeated medical appointments. For young children, conventional dental treatment can be particularly challenging, as some are too young to remain still or experience significant anxiety. SDF offers an alternative because it can be applied quickly without the equipment and procedures required for a traditional filling.
There is one important tradeoff: SDF permanently turns the decayed portion of a treated tooth dark, which can be especially noticeable on front teeth. The discoloration is primarily cosmetic, but it may influence whether patients and families choose the treatment.
Silver diamine fluoride is not a new substance. Dentists have used it to manage cavities in numerous countries for decades. In the United States, the FDA approved SDF as a medical device for treating tooth sensitivity in 2014, and dentists have used it off-label to stop cavities. What has been missing is large-scale clinical evidence from U.S. populations establishing its safety and effectiveness for treating tooth decay, a key step toward obtaining FDA approval for that specific use.
"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," Fontana said. "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."
The investigation began in 2018 and continued despite disruptions from the COVID-19 pandemic. The researchers believe stronger clinical evidence could make SDF more widely available, including in pediatric medical settings where children often receive care long before their first dental appointment.
Amr Moursi, a professor of pediatric dentistry at New York University College of Dentistry and a co-principal investigator, emphasized the potential importance of regulatory change. "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," he said.
The trial brought together researchers from the University of Michigan, New York University, the University of Iowa, and Indiana University. The National Institute of Dental and Craniofacial Research provided more than $12 million in funding. The product tested was Advantage Arrest 38% SDF, supplied by Elevate Oral Care.