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 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

children. 

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

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.