October 10, 2017
NIH-Funded Study to Test Cavity-Fighting Liquid at Three Clinical Sites
The National Institute of Dental & Craniofacial Research, part of the National Institutes of Health, has awarded a grant that will provide funding to New York University College of Dentistry (NYU Dentistry) and its collaborators to test the effectiveness of silver diamine fluoride in stopping the progression of cavities in young children.
The grant provides $9.8 million over four years, $2.8 million of which will come to NYU Dentistry, to fund a Phase III randomized controlled trial at three clinical sites: University of Michigan, University of Iowa, and NYU Dentistry. University of Michigan’s Margherita Fontana, DDS, PhD, leads the study.
Cavities early in childhood are one of the most prevalent chronic conditions among U.S. children, especially those from low-income families. If allowed to progress untreated, cavities can have broad dental, medical, social, and quality of life consequences.
“Early childhood cavities are preventable, yet once they are established and left untreated they can have severe consequences on the health and wellness of both the affected children and the families that care for them,” said Amr M. Moursi, DDS, PhD, chair of the Department of Pediatric Dentistry at NYU Dentistry and principal investigator at the NYU study site.
“For many young children who need extensive dental treatment, their only option is to undergo general anesthesia in order to receive fillings or extractions. Given the limited availability, potential risks, and high cost of general anesthesia in a hospital setting, we are interested in finding alternative methods to manage cavities.”
Silver diamine fluoride was approved in the U.S. in 2014 for the treatment of dental hypersensitivity. However, it has been used for many years in other countries for cavity control. The liquid can be applied to a cavity to arrest tooth decay and in some cases replace the need for a filling or crown.
In 2016, the FDA designated silver diamine fluoride a “breakthrough therapy,” a process which is designed to expedite drug development. This NIH-funded study will provide the necessary data for obtaining a cavity arrest drug claim for silver diamine fluoride in the U.S.
The study will closely follow more than 1,000 children, ages 2-5, enrolled in Head Start and other preschool programs. The researchers will treat children and monitor them over a school year to study the impact of silver diamine fluoride applied twice, six months apart, on cavity progression. They will also measure oral health-related quality of life and treatment satisfaction and acceptability.
“Should the trial be successful, the impact would be a change in the standard of care for the management of tooth decay in young children. It will also expand access to, and adoption of, a simple, non-invasive, inexpensive strategy for cavity management,” said Moursi. “We hope that access to this simple treatment could also help in reducing oral health disparities.”
Additional NYU Dentistry investigators include Drs. Yihong Li, Courtney Chinn, and Mark Wolff. The NYU Bluestone Center for Clinical Research will also collaborate on this study. In addition to investigators from the University of Michigan and the University of Iowa, the clinical trial includes researchers from Indiana University, University of Otago in New Zealand, University of Hong Kong and University of Baltimore. The grant (Award Number U01DE027372) began in September 2017.