A major clinical trial has confirmed that a simple, inexpensive liquid can stop tooth decay in young children, potentially preventing painful infections and the need for dental surgery. The treatment, called silver diamine fluoride, takes only seconds to apply to each affected tooth. Rather than removing damaged tooth material and placing a filling, a dentist uses a tiny sponge tipped applicator to paint the liquid directly onto the cavity. The process requires no drilling, injections, or sedation.
Phase III Trial Results in JAMA Pediatrics
Published in JAMA Pediatrics, the Phase III clinical trial included 830 children younger than 6. Participants were recruited through dental clinics, pediatric medical practices, and Head Start and Early 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 the affected baby teeth when treatment was provided 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. Instead, it helps prevent 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.
Addressing a Public Health Gap
Tooth decay is the most common chronic disease among children, affecting more than 40% of American children. Although cavities may initially cause few noticeable symptoms, untreated decay can eventually lead to severe toothaches, infections, problems eating and sleeping, missed school days, and repeated medical appointments. For young children, conventional dental treatment can also be particularly challenging. Some are too young to remain still throughout a procedure, while others experience significant fear or anxiety.
Every year, thousands of young children in the United States visit emergency departments because of untreated cavities. Emergency physicians generally cannot provide the dental procedures needed to address the underlying problem, leaving some children with ongoing pain and infections. Others ultimately need dental surgery under general anesthesia, which makes them completely unconscious during the procedure.
SDF offers an alternative for many of these patients because it can be applied quickly without the equipment and procedures required for a traditional filling. Fontana said the benefits could extend well beyond young children. Older adults, people with developmental or physical disabilities, individuals with severe dental anxiety, and patients who have difficulty obtaining conventional dental care could also benefit.
Regulatory Hurdles and Future Access
Silver diamine fluoride is not a newly invented substance. Dentists have successfully 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. Dentists have also used it off-label to stop cavities, meaning they apply an authorized product for a purpose beyond its original approved indication.
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. The University of Michigan trial was designed to help fill that gap. The investigation began in 2018 and continued despite the major disruptions caused by 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. “In medicine, clinicians want high-quality evidence before changing practice,” Fontana said. “It is important to have data they can refer to because young children often see pediatricians years before they ever visit a dentist, broader acceptance could allow many more cavities to be treated while a referral to a dental home is successful, and before they become painful, infected or require surgery.”
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, part of the National Institutes of Health, provided more than $12 million in funding. The product tested was Advantage Arrest 38% SDF, supplied by Elevate Oral Care. The findings provide clinical trial evidence that the manufacturer can use in an application seeking FDA approval of SDF as a drug for arresting dental caries, the medical term for tooth decay.
Amr Moursi, a professor of pediatric dentistry at New York University College of Dentistry and a co-principal investigator, emphasized the potential importance of that 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,” said Moursi.
There is, however, 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. For many people, avoiding pain, drilling, or more invasive procedures may outweigh that drawback. For some children, receiving another application of SDF every few months could be sufficient to keep a cavity under control until the affected baby tooth naturally falls out.
“For almost anyone, this can arrest the decay and stop the infection and the pain it causes,” Fontana said. “This could benefit many people.”
Source: ScienceDaily
