NIH-funded study finds non-invasive application of silver diamine fluoride superior to placebo
A topical liquid, silver diamine fluoride (SDF), can 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 treated with a placebo. The study was funded by the National Institute of Dental and Craniofacial Research (NIDCR), part of NIH.
SDF is cleared by the Food and Drug Administration for treating dental sensitivity and is used off label to treat tooth decay, also known as cavities or dental caries. It can be easily and painlessly swabbed onto cavities and has been widely used for management of tooth decay in other countries for decades. Studies suggest that the silver in SDF kills cavity-causing microbes and helps stop destruction of the tooth, while the fluoride helps to rebuild and strengthen the tooth.
“Current treatments for severe early childhood caries rely on restoration and tooth extraction, which can involve general anesthesia,” said lead investigator Margherita Fontana, D.D.S., 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 — SDF is a game changer.”
Researchers recruited children between the ages of 1 and 5 with severe tooth decay. An interim analysis of 599 children evaluated the proportion of cavity lesions in which decay progression was stopped six months after a single treatment with SDF or a placebo.
To document the effectiveness of SDF, the researchers measured the hardness of cavities before and after treatment. When decay is ongoing, the affected part of the tooth is soft, whereas a hardening of the area indicates that decay has been 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. Ending a trial early can allow particularly effective interventions to move toward FDA approval, and thus, availability to patients, sooner.
“SDF marketing authorization from FDA for treating 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, D.D.S., M.S.D., M.S., director of NIDCR’s Center for Clinical Research and the Clinical Trials and Practice-Based Research Program. “Increasing patients’ access to caries treatment is essential for reaching children who are most in need.”
Researchers are now analyzing the final data on over 800 children, including assessing SDF’s effects on tooth 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, the researchers are also evaluating patient and parent satisfaction and acceptability. While SDF appears to be quite effective, not every cavity responded to the treatment. Scientists will use future studies to figure out why.
“Oral health problems, such as untreated tooth decay, can have many public health impacts that affect both children and adults,” said NIDCR Director Rena D’Souza, D.D.S., Ph.D., M.S. “This study provides evidence that SDF could be a powerful tool against cavities and help improve health and well-being of children.”
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-Hispanic Black children and children from lower-income households. Left untreated, cavities can put children at risk for chronic pain, impaired development, and long-term oral and overall health problems. In severe cases, bacteria from a tooth infection can even travel through the body and cause death.
This research was supported by NIDCR grant UH3-DE027372. For more information about the trial, visit clinicaltrials.gov and search identifier NCT 03649659.
About the National Institute of Dental and Craniofacial Research: NIDCR is the nation’s leading funder of research on oral, dental, and craniofacial health.
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 U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.