Liquid Approach Shows Promise in Arresting Childhood Tooth Decay

A cavity does not always require drilling, injections, or an uncomfortable dental visit. A major clinical trial has confirmed that a simple, inexpensive liquid can stop tooth decay in young children, potentially preventing painful infections and reducing the need for dental surgery.

The approach, called silver diamine fluoride (SDF), can be applied to an affected tooth in seconds. Rather than removing decayed tooth material and placing a filling, a dentist uses a small sponge-tipped applicator to paint the liquid directly onto the cavity. The procedure requires no drilling, injections, or sedation.

The results suggest major implications for childhood dental care. Each 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 eventually need dental surgery under general anesthesia, which places the child in a state of unconsciousness during the procedure.

Now researchers led by the University of Michigan have reported compelling evidence that a much simpler approach may stop many cavities from progressing.

The study, published in JAMA Pediatrics, was a Phase III clinical trial involving 830 children younger than age 6. Participants were recruited through dental clinics, pediatric medical 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 findings showed that a solution containing 38% silver diamine fluoride successfully stopped decay in more than half of the affected baby teeth when treatment was repeated at six-month intervals.

Dentists refer to this outcome 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 appears to work 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.

The treatment could help millions avoid dental pain, according to the researchers. 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 with eating and sleeping, missed school days, and repeated medical appointments.

For young children, conventional dental treatment can be especially challenging. Some are too young to remain still throughout a procedure, while others experience significant fear or anxiety. SDF offers an alternative for many patients because it can be applied quickly without the equipment and procedures required for a traditional filling.

Dr. Fontana said the benefits could extend 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.

There is, however, an important tradeoff. SDF permanently turns the decayed portion of a treated tooth dark, which may 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.

Silver diamine fluoride is not newly invented. 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. 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.

“If we want more children and families to benefit from this treatment, we need rigorous evidence showing both that it works and that it is 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 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 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.”

A dental home refers to an ongoing relationship with a dental care provider who can deliver preventive care, treatment, and follow-up services. Expanding access to SDF could allow more children to receive early intervention before relatively manageable cavities develop into serious dental problems.

The 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 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 that could lead to increased utilization by providers, enhanced payments by insurers, and more consistent product quality,” said Moursi, a co-principal investigator on the study.

For some children, receiving another application of SDF every few months may be sufficient to keep a cavity under control until the affected baby tooth naturally falls out. Adults could also benefit, either by using SDF to manage decay over a longer period or as a temporary solution until a filling or another restorative procedure becomes affordable or practical.

The treatment is not suitable for every cavity, and stopping decay does not necessarily eliminate the need for future dental work. Nevertheless, the findings suggest that a procedure requiring only seconds to perform could help many patients avoid more complicated treatment.

“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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