Thousands of young children in the United States are sent to emergency departments each year because of untreated cavities. Doctors at the hospital are usually unable to repair the underlying dental problem, so some children continue to suffer from pain and infection, and others may eventually require surgery under general anesthesia.
A low-cost liquid known as silver fluoride diamine (SDF) may offer an easier option. Your dentist applies this directly to the cavity using a small sponge-tipped applicator. This process only takes a few seconds for each tooth. This treatment can stop tooth decay without the need for drilling, injections, or sedation.
Treatments used for a long time gain stronger evidence
SDF has been used successfully in many countries for decades. Dentists have been using it off-label in the United States since 2014, when it was approved as a medical device to reduce tooth sensitivity.
However, researchers had not yet completed the large-scale clinical trials in the United States needed to demonstrate its safety and effectiveness as a treatment for cavities. The Food and Drug Administration would need evidence to approve SDF as a treatment for cavities.
A clinical trial led by the University of Michigan now provides those data.
Phase III research is JAMA PediatricsParticipants were recruited through dental clinics, pediatric medical practices, Head Start, and Early Head Start programs in Michigan, New York, and Iowa.
Self-Defense Forces stopped cavities in many baby teeth
The researchers found that 38% of SDF stopped cavities in more than half of the affected baby teeth when treated every six months.
Traditional cavity treatment usually involves removing the damaged tooth structure and placing a filling. SDF does not require tooth extraction. Instead, the liquid is applied directly to the rotten area.
“This is a very effective and safe treatment, even for children as young as one year old,” said Margherita Fontana, a professor of dentistry at the University of Michigan School of Dentistry and principal investigator of the study.
Tooth decay is the most common chronic disease among children, affecting more than 40% of children in the United States. If untreated, cavities can cause severe pain, infection, difficulty sleeping and eating, missed school, and repeated medical visits.
Potential options for difficult-to-treat patients
Fontana said SDF may be particularly useful for young children, the elderly, people with developmental or physical disabilities, and patients with severe dental anxiety. It may also be helpful for people who have limited access to conventional dental treatment or who cannot easily tolerate standard procedures.
This treatment has obvious drawbacks. Silver permanently darkens the decayed areas of your teeth.
“If we want more children and families to benefit from this treatment, we need rigorous evidence showing both its effectiveness and safety. From a public health perspective, if we want to implement it more broadly across the United States, including in health care settings, we need carefully collected data from the U.S. population, and we now have it,” Fontana said.
The research began in 2018 and continued despite disruptions caused by the coronavirus pandemic.
“In medicine, clinicians want high-quality evidence before changing their practice,” Fontana says. “It’s important to have data to refer to because young children often see their pediatrician years before visiting the dentist. Widespread acceptance could potentially treat more cavities before they become painful, infected, or require surgery until a successful referral to the dentist.”
Findings could support FDA approval
Fontana collaborated with researchers at New York University, the University of Iowa, Indiana University, and the NIH’s National Institute of Dental and Craniofacial Research. The institute provided more than $12 million to support this research.
This trial provided the clinical evidence the manufacturer needed to submit a cavity-fighting drug to the FDA. Elevate Oral Care offered the product tested in the study, Advantage Arrest 38% SDF.
Amr Mursi, a professor of pediatric dentistry at New York University School of Dentistry, said the findings could help expand access to treatment.
“Our results support FDA approval for the administration of SDF for the prevention of dental caries in young children. Removing SDF from off-label status would be an important innovation that could lead to increased utilization by health care providers, enhanced payment by insurance companies, and more consistent product quality,” said Moorsi, co-principal investigator of the study.
Bridging or long-term treatment
In some children, reapplying SDF every few months may help control cavities until the baby tooth falls out on its own. In adults, it may serve as long-term treatment or temporary protection until restorative treatment becomes affordable or practical.
“For just about anyone, this can stop tooth decay and stop infection and the pain it causes,” Fontana said. “This could benefit many people.”
