NYU Dentistry Receives $2.8 Million as Part of Multi-Center Study to Stop the Progression of Caries in Children
NYU Dentistry Receives $2.8 Million as Part of Multi Center Study to Stop the Progression of Caries in Children The National Institute of Dental & Craniofacial Research, part of the National Institutes of Health, has awarded a grant to a
NYU Dentistry Receives $2.8 Million as Part of Multi-Center Study to Stop the Progression of Cavities in Children
The National Institute of Dental & Craniofacial
Research, part of the National Institutes of Health, has awarded a grant to a
team of researchers – led by the University of Michigan and Margherita Fontana,
DDS, PhD – that will provide funding to New York University College of
Dentistry (NYU Dentistry) and other collaborators to test the effectiveness of
silver diamine fluoride in stopping the progression of cavities in young
The grant provides $9.8 million over 4 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.
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
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.