Silver Diamine Fluoride Halts Cavities in Baby Teeth Without Drilling, Major U.S. Trial Finds

A dentist holds a small sponge-tipped applicator, dabs a clear liquid onto a decayed baby tooth, and moves to the next one. Each tooth takes a few seconds. There is no drill, no injection, and no sedation. That is the treatment a University of Michigan-led team has now tested in one of the largest U.S. trials of its kind, and the results point to a simpler way of handling cavities in very young children.

The liquid is silver diamine fluoride, known as SDF. The trial found that a 38% solution stopped decay in more than half of the affected baby teeth when it was applied every six months. The study was a Phase III trial published in JAMA Pediatrics, and it enrolled 830 children younger than 6. Families were recruited through dental offices, pediatric medical practices, and Head Start and Early Head Start programs in Michigan, New York and Iowa.

SDF is not new. Many countries have used it successfully 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. What was missing was large-scale U.S. clinical evidence of its safety and effectiveness against cavities, the kind the Food and Drug Administration would need before approving it as a drug for treating tooth decay. This trial supplies that evidence.

The usual alternative is to remove damaged tooth material and place a filling. SDF skips the removal and is painted directly onto the decayed area. Margherita Fontana, a professor at the University of Michigan School of Dentistry and the study's lead investigator, called it a very effective and safe treatment, even in children as young as 1.

The stakes are real. Tooth decay is the most common chronic disease among children and affects more than 40% of children in the United States. Left untreated, cavities can cause intense pain, infections, trouble sleeping or eating, missed school days, and repeated medical appointments.

There is a visible cost. The silver permanently turns the decayed part of the tooth dark. Fontana said the treatment could be especially useful for very young children, older adults, people with developmental or physical disabilities, and patients with severe dental anxiety, as well as people with limited access to conventional dental care or who cannot easily tolerate standard procedures.

The research began in 2018 and continued through the disruptions of the COVID-19 pandemic. Fontana worked with colleagues at New York University, the University of Iowa and Indiana University, and with the NIH's National Institute of Dental and Craniofacial Research, which provided more than $12 million. Elevate Oral Care supplied Advantage Arrest 38% SDF, the product tested. Fontana said that young children often see pediatricians years before they see a dentist, so data that medical clinicians can trust could allow more cavities to be treated before they become painful, infected, or need surgery, while a referral to a dental home is arranged.

For some children, repeating the application every few months may hold a cavity in check until the baby tooth falls out naturally. In adults, it could serve as a long-term treatment or as protection until a restoration becomes affordable or practical.

The trial gives the manufacturer the clinical evidence it needs to submit a dental caries drug application to the FDA. Amr Moursi, a professor of pediatric dentistry at NYU College of Dentistry and co-principal investigator, said approval would end SDF's off-label status, which could mean more use by providers, better insurer payment, and more consistent product quality. The next thing to watch is that submission.