Early childhood caries plagues many children in the United States, particularly among low-income families. That’s why the New York University College of Dentistry (NYU Dentistry) is leading a $9.8 million study funded by the National Institute of Dental & Craniofacial Research into the effectiveness of silver diamine fluoride in stopping caries progression in children.
“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 the school.
“For many young children who need extensive dental treatment, their only option is to undergo general anesthesia in order to receive fillings or extractions,” Moursi said. “Given the limited availability, potential risks, and high cost of general anesthesia in a hospital setting, we are interested in finding alternative methods to managing cavities.”
Silver diamine fluoride was approved in the United States in 2014 for treating 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 a crown.
In 2016, the Food and Drug Administration designated silver diamine fluoride a “breakthrough therapy,” a process designed to expedite drug development. The NYU Dentistry study will provide the necessary data for obtaining a cavity arrest drug claim for silver diamine fluoride in the United States.
The Phase III randomized controlled trial will be held at clinical sites at NYU Dentistry, the University of Michigan, and the University of Iowa. It will follow more than 1,000 children ages 2 to 5 years enrolled in Head Start and other preschool programs.
The researchers will treat and monitor the children over a school year to study the impact of silver diamine fluoride applied twice, 6 months apart, on cavity progression. They also will 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, noninvasive strategy for cavity management,” said Moursi. “We hope that access to this simple treatment could also help in reducing oral health disparities.”
$13.3 Million Study to Compare Silver and Sealants in Cavity Prevention
Grant to Further Compare Silver and Sealants in Cavity Prevention
$317K Grant to Be Used to Evaluate School-Based Caries Prevention