PCORI approves $13 million funding award to NYU Dentistry for school-based cavity prevention study

A research team at New York University College of Dentistry (NYU Dentistry) has been approved for a $13.3 million funding award by the Patient-Centered Outcomes Research Institute (PCORI) to study cavity prevention, quality of life, and school performance.

NYU Dentistry's Richard Niederman, DMD, and Ryan Richard Ruff, MPH, PhD, will lead the five-year study comparing the effectiveness of two cavity-prevention techniques -- a "simple" treatment of topical silver and fluoride, and a "complex" treatment of traditional sealants and fluoride. The study will be conducted in elementary schools in the Bronx, an area with a scarcity of dental care providers and clinics.

More than half of U.S. elementary school-age children have had a dental cavity, and more than 20 percent have untreated cavities. The prevalence of cavities in the Bronx - the poorest borough in New York City and home to a large Hispanic/Latino population - is almost twice the national average.

Children with dental cavities and associated toothaches face multiple disadvantages, including reduced quality of life, school absences, difficulty paying attention in school, and lower standardized test scores. Unfortunately, traditional office-based dental care presents multiple barriers to treatment, including cost, fear of dentists, and geographic isolation. Bringing care to children instead of children to care eliminates these barriers.

Through prior work in New York, Massachusetts, New Hampshire, Maine, and Colorado, NYU Dentistry researchers determined that "complex" school-based cavity prevention programs are effective in reducing cavities by two-thirds. Preliminary results suggest that "simple" prevention can be equally effective. Discussions and surveys of patients and other partners revealed that school-based care was overwhelmingly preferred over office-based care and that "simple" care was preferred over "complex" care.

In the PCORI-funded study, the researchers will compare cavity prevention programs in 60 high-need elementary schools in the Bronx that serve low-income, Hispanic/Latino families. Schools will be selected at random to receive either the "simple" treatment of silver diamine fluoride and fluoride varnish, or the "complex" treatment of sealants and fluoride varnish. All children will receive the same preventive dental care twice each year. The researchers will assess untreated cavities, quality of life, and student achievement to compare the outcomes of both treatments.

A unique aspect of the study is its collaboration with the NYU Rory Meyers College of Nursing to deliver care, along with NYU dental hygienists. Since there are 3 million nurses in the U.S., versus 250,000 dental hygienists, the research team will also compare care delivered by nurses and by dental hygienists. The participation of nurses will build upon NYU Meyers' efforts to expand oral health nursing education and practice and to strengthen existing oral health and nursing initiatives.

"The overall goal of our proposed research is to improve oral health equity by determining the most effective, patient-centered, and efficient school-based cavity prevention methods," said Dr. Niederman, professor and chair of the Department Epidemiology & Health Promotion at NYU Dentistry. "Our expectation is that both will be similarly effective in reducing untreated cavities by two thirds. However, for the same time and cost, hygienists or nurses can treat four times more children with the simpler prevention."

The study was selected for funding through PCORI's Pragmatic Clinical Studies Initiative, an effort to produce results that are broadly applicable to a diverse range of patients and care situations and can be more quickly taken up in routine clinical practice.

"This is an unparalleled opportunity to explore the long-term impact of oral health on quality of life and student achievement," said Dr. Ruff, assistant professor of epidemiology & health promotion at NYU Dentistry. "This research has the potential to improve multiple outcomes relevant to children and their families."

Many clinical studies test whether a treatment works under ideal conditions in specialized research centers, but health care is rarely delivered in such idealized situations and settings. Pragmatic clinical studies test a treatment's effectiveness in "real-life" practice situations, such as typical hospitals, clinics, and schools, and can include a wider range of study participants, making their findings more generally applicable.

"This project was selected for PCORI funding not only for its scientific merit and commitment to engaging patients and other healthcare stakeholders in a major study conducted in real-world settings, but also for its potential to answer an important question about oral health and fill a crucial evidence gap," said PCORI Executive Director Joe Selby, MD, MPH. "We look forward to following the study's progress and working with NYU College of Dentistry to share its results."

The NYU Dentistry study was selected through a highly competitive review process in which patients, caregivers, and other stakeholders joined scientists to evaluate the proposals.

The award to Drs. Niederman and Ruff has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.