Topical solution stops tooth decay in children

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Friday, March 8, 2024

NIH-funded study finds noninvasive application of silver diamine fluoride superior to placebo.

A topical liquid, silver diamine fluoride (SDF), may stop tooth decay in young children, according to a large clinical trial funded by the National Institutes of Health. The preliminary results, published in pediatric dentistry, showed that 54% of cavities stopped progressing after SDF treatment, compared to 21% of those who received placebo. The study was funded by the National Institute of Dental and Craniofacial Research (NIDCR), part of the NIH.

SDF is approved by the Food and Drug Administration for the treatment of tooth sensitivity and is used off-label to treat dental caries, also known as tooth decay or tooth decay. It can be placed easily and painlessly in cavities and has been widely used in caries management in other countries for decades. Studies show that the silver in SDF kills cavity-causing microbes and helps stop tooth decay, while the fluoride helps rebuild and strengthen the tooth.

“Current treatments for severe early childhood caries rely on tooth restoration and extraction, which may involve general anesthesia,” said lead researcher Margherita Fontana, DDS, Ph.D., of the University of Michigan. “These interventions are expensive, cavities often return, and anesthesia can have long-term effects on a developing brain. We didn’t really have any other options until recently – the SDF is a game changer.”

The researchers recruited children aged 1 to 5 years with severe dental caries. An interim analysis of 599 children assessed the proportion of cavity lesions in which caries progression stopped six months after a single treatment with SDF or placebo.

To document the effectiveness of SDF, the researchers measured the hardness of the cavities before and after treatment. When tooth decay is in progress, the affected part of the tooth is soft, while hardening of the area indicates that the tooth decay has stopped. The team reported no safety concerns with the treatment. Because the planned interim analysis revealed that the study had met its primary endpoint—to show that SDF was effective in halting the progression of cavities—the trial was stopped early. Early termination of a trial may allow highly effective interventions to move toward FDA approval, and thus availability to patients, sooner.

“The FDA’s clearance of SDF for the treatment of dental cavities could lead to SDF becoming more widely available. more acceptable among providers, patients and parents; and more likely to be covered by insurance,” said Dena Fischer, DDS, MSD, MS, director of NIDCR’s Center for Clinical Research and Clinical Trials and Practice Research Program. “Increasing patient access to dental caries treatment is essential to reaching children most in need.”

The researchers are now analyzing final data from more than 800 children, including assessing the effects of SDF on dental pain and quality of life, as well as potential side effects. Because SDF can darken the color of cavities, which may not be aesthetically pleasing, researchers are also evaluating patient and parent satisfaction and acceptance. While SDF appears to be quite effective, not every cavity responded to the treatment. Scientists will use future studies to understand why.

“Oral health problems such as untreated tooth decay can have many public health implications that affect both children and adults,” said NIDCR Director Rena D’Souza, DDS, Ph.D., MS “This study provides evidence that SDF could be a powerful anti-caries tool and help improve children’s health and well-being.”

Tooth decay is the most common chronic disease of childhood, affecting nearly 46% of children in the United States, according to the Centers for Disease Control and Prevention. It disproportionately affects Hispanic and non-black children and children from lower-income households. If left untreated, cavities can put children at risk for chronic pain, impaired growth, and long-term oral and general health problems. In severe cases, bacteria from a tooth infection can even travel through the body and cause death.

This research was supported by the NIDCR grant UH3-DE027372. For more information about the trial, visit clinicaltrials.gov and search for the ID NCT 03649659.

About the National Institute of Dental and Craniofacial Research: NIDCR is the nation’s leading funder of oral, dental, and craniofacial health research.

About the National Institutes of Health (NIH):NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the US Department of Health and Human Services. NIH is the primary federal agency that conducts and supports basic, clinical, and translational medical research and investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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