In what is regarded as one of the largest controlled studies of adult tooth decay prevention ever undertaken, Athena Papas, the Erling Johansen Professor of Dental Research, is nearing completion of a four-site, $11 million clinical trial to test the effectiveness of a chemical coating that combats the bacteria responsible for cavities.
“This is a groundbreaking study, and hopefully it will have an impact on the dental profession,” says Athena Papas, the Erling Johansen Professor of Dental Research. Photo: iStockphoto
While the results of the trial won’t be available until later this year, the preliminary findings are promising. “It’s the first new thing to be tried since fluoride,” Papas says.
Cavities—or dental caries, as they are known in the profession—are the most prevalent chronic disease of adults and children in the United States, and even more adults will experience tooth decay because they’re living longer. Cavities in adults also pose a substantial economic burden, Papas says, accounting for up to 5 percent of the nation’s health-care spending.
The anti-bacterial coating, a 10 percent concentration of the antiseptic chlorhexidine, penetrates into the teeth and leaches out slowly over several weeks. “It takes about six months for the effects of the coating to wear off,” Papas says, which means dentists would be able to apply the coating at their patients’ regularly scheduled examination and cleaning appointments.
The FDA has already approved the use of chlorhexidine, in a much lower concentration, in mouthwashes to reduce plaque and bacteria. The chlorhexidine coating, which is manufactured under the brand name Prevora, is currently available to dentists in Canada and Ireland.
The clinical trial, dubbed the Prevention of Adult Caries Study, has followed nearly 1,000 patients from diverse populations all over the country over 13 months. The goal has been to study patients who visit the dentist regularly, as well as those without access to routine dental care.
This is the third phase of an FDA clinical trial that is being funded by the National Institute of Dental and Craniofacial Research, part of the National Institutes of Health, and CHX Technologies Inc., which manufactures the coating. Phase two followed 236 patients with the condition called xerostomia—dry mouth that makes them more prone to tooth decay—from Tufts, the University of British Columbia and the University of Western Ontario. Researchers “found that [the coating] does decrease tooth decay among xerostomic adults,” Papas says.
Most Americans over the age of 55 have tooth decay, yet most cavity prevention programs have focused on children. One recent study concluded that older adults experience the same if not higher rates of cavities than kids. Age-related conditions such as gum recession, which exposes tooth roots to plaque, and decay around fillings account for the higher incidence of cavities in older Americans, according to the American Dental Association.
For adults at the greatest risk for tooth decay, the current preventive treatment is prescription-strength fluoride, a regimen that has remained unchanged for years. But in 2001, an NIH conference determined that something more needed to be done. Conference participants concluded that “we needed to do some randomized trials to find out what works and what doesn’t work so we can provide good data to dentists,” Papas says.
Data from Papas’ study are being compiled, and she expects to report on the results later this year. “This is a groundbreaking study,” she says, “and hopefully it will have an impact on the dental profession.”
Julie Flaherty can be reached at julie.flaherty@tufts.edu.
This article first appeared in the Spring 2010 issue of Tufts Dental Medicine magazine.