A cavity doesn’t always mean drilling, injections, or an uncomfortable visit to the dentist. 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 (SDF), takes just seconds to apply to each affected tooth. Rather than removing damaged tooth material and placing a filling, a dentist uses a small sponge-tipped applicator to apply fluid directly to the cavity. The process does not require any drilling, injections or sedation.
The findings could have huge implications for children’s dental care. Every year, thousands of young children in the United States visit emergency rooms due to untreated cavities. Emergency doctors usually cannot provide the dental procedures needed to resolve the underlying problem, leaving some children with persistent pain and infections. Others ultimately need dental surgery under general anesthesia, which renders them completely unconscious during the procedure.
Now, researchers led by the University of Michigan have produced compelling evidence that a much simpler approach can prevent many cavities from getting worse.
Major clinical trial confirms effectiveness of silver diamine fluoride
Published in JAMA Pediatricsthe phase III clinical trial included 830 children under 6 years old. Participants were recruited from dental clinics, pediatric practices, and Head Start and Early Head Start programs in Michigan, New York, and Iowa.
Head Start and Early Head Start are federally supported programs that provide early childhood education and related services to eligible families.
The results showed that a solution containing 38% silver diamine fluoride successfully stopped decay in more than half of affected baby teeth when treatment was administered at six-month intervals.
Dentists call this stopping tooth decay, which means the damaged area stops deteriorating. Unlike a traditional filling, the treatment does not replace lost tooth structure. Instead, it helps prevent existing degradation from progressing.
SDF works through the combined effects of silver and fluoride. Silver helps fight 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 year old,” said Margherita Fontana, professor of dentistry at the University of Michigan School of Dentistry and principal investigator of the study.
Simple treatment could help millions avoid tooth pain
Tooth decay is the most common chronic disease among children, affecting more than 40% of American children. Although cavities may initially cause few visible symptoms, untreated decay can eventually lead to severe toothaches, infections, eating and sleeping problems, missed school days, and repeated medical appointments.
For young children, conventional dental care can also be particularly difficult. Some are too young to remain still throughout a procedure, while others experience significant fear or anxiety.
SDF offers an alternative for many of these patients because it can be applied quickly without the equipment or procedures required for a traditional filling.
Fontana said the benefits could extend far beyond young children. Older adults, people with developmental or physical disabilities, people with severe dental anxiety, and patients who have difficulty obtaining conventional dental care might also benefit.
There is, however, an important trade-off. SDF permanently darkens the decayed portion of a treated tooth, which may be especially noticeable on the front teeth. Discoloration is primarily aesthetic, but it can influence the choice of treatment by patients and their families.
For many people, avoiding pain, piercings, or more invasive procedures can offset this drawback.
Why this decades-old treatment could soon reach more patients
Silver diamine fluoride is not a newly invented substance. Dentists have used it successfully for decades to manage cavities in many countries.
In the United States, the FDA approved SDF as a medical device to treat tooth sensitivity in 2014. Dentists have also used it off-label to stop cavities, meaning they apply an authorized product for purposes beyond its initially approved indication.
What’s missing is large-scale clinical evidence from U.S. populations establishing its safety and effectiveness in treating tooth decay, a key step toward gaining FDA approval for this specific use.
The University of Michigan trial was designed to fill this gap.
“If we want more children and families to benefit from this treatment, we need rigorous evidence demonstrating both its effectiveness and safety. From a public health perspective, if we want broader implementation across the United States, including in medical settings, we need carefully collected data from American populations, and we have it now,” Fontana said.
The investigation began in 2018 and continued despite major disruptions caused by the COVID-19 pandemic.
Researchers believe stronger clinical evidence could make SDF more widely available, including in pediatric medical settings where children often receive care well before their first dental appointment.
“In medicine, clinicians want high-quality evidence before changing practice,” Fontana said. “Having data they can refer to is important because young children often see pediatricians years before seeing a dentist. Wider acceptance could allow many more cavities to be treated during a successful dental referral and before they become painful, infected, or require surgery.”
A dental practice refers to an ongoing relationship with a dental provider who can provide preventive care, treatment, and follow-up services.
Expanding access to SDF could allow more children to benefit from early intervention before relatively manageable cavities develop into serious dental problems.
FDA approval could expand access to cavity treatment
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 results provide clinical trial evidence that the manufacturer can use in an application for FDA approval of SDF as a drug to stop tooth decay, the medical term for tooth decay.
Amr Moursi, professor of pediatric dentistry at New York University College of Dentistry and co-principal investigator, highlighted the potential importance of this regulatory change.
“Our results support FDA approval of SDF to manage tooth decay arrest in young children. Removing SDF from off-label status would be an important innovation that could lead to increased use by providers, improved payments by insurers, and more consistent product quality,” said Moursi, co-principal investigator of the study.
For some children, receiving another application of SDF every few months might be enough to keep a cavity under control until the affected baby tooth falls out naturally.
Adults could also benefit, either by using SDF to manage decay over a longer period of time, or as a temporary solution until a filling or other restorative procedure becomes affordable or practical.
Treatment is not suitable for all cavities, and stopping cavities does not necessarily eliminate the need for future dental care. Still, the results suggest that a procedure requiring just seconds could help many patients avoid more complicated treatment.
“For almost everyone, it can stop the decay and stop the infection and the pain it causes,” Fontana said. “It could benefit a lot of people.”
Gn Health
