Advantage Silver Dental Arrest, LLC and Elevate Oral Care, LLC announced today that the National Institute of Dental and Craniofacial Research (NIDCR) of the National Institutes of Health (NIH) has provided $9.8 million to fund a Phase III randomized clinical trial using Advantage Arrest® Silver Diamine Fluoride 38% for arresting caries in children. This grant represents another major milestone for Advantage Arrest® Silver Diamine Fluoride 38%.
Advantage Arrest® Silver Diamine Fluoride 38% was cleared as a medical device in 2014 for the treatment of dentinal hypersensitivity, the same clearance given to 2.5% and 5% sodium fluoride varnish. It is extensively being used off-label in the US for arresting and preventing caries in children and adults.
In 2016, Advantage Arrest® Silver Diamine Fluoride 38% was the first product ever to receive the FDA’s Breakthrough Therapy Designation (BTD) for the arrest of tooth decay in children and adults. It is the only oral care product to ever receive this prestigious designation. BTD represents the FDA’s effort to address an unmet, serious, life-threatening medical need where there is no available therapy.
In use for over 50 years as a caries-arresting drug in Japan and other countries, the Designation was granted based on the FDA review of 10 worldwide randomized clinical trials evaluating silver diamine fluoride for caries arrest in children aged 3-9 or adults aged 60-89, as well as studies conducted by Advantage Silver Dental Arrest, LLC. Collectively these trials involved approximately 1500 subjects who were monitored for 1-3 years.
The American Dental Association added a new Code on Dental Procedures and Nomenclature (CDT Code D1354 – Interim Caries Arresting Medicament Application) to achieve uniformity, consistency and specificity in accurately documenting treatment for the efficient processing of dental claims. Multiple insurers and State Medicaid programs in AK, CA, IA, KS, ME, MI, MN, NC, NJ, OR, TN, VA, and WI are currently said to be reimbursing for the cost of the therapy for caries arrest.
“The NIDCR funding represents another major milestone in our over nine year effort, spearheaded by Dr. Peter Milgrom of Advantage Silver Dental Arrest and the University of Washington Dental School. Knowing how this option continues to improve the treatment of dental caries, not just with patients in low socioeconomic circumstances, but for numerous Americans across all age and economic spectrums has been extremely gratifying for me as a health professional” said Dr. Mike Shirtcliff, President of Advantage Silver Dental Arrest, LLC.
Kevin Thomas, President of Elevate Oral Care, the commercialization organization for Advantage Arrest Silver Diamine Fluoride 38% stated, “We are proud to be a part of helping to significantly improve the oral health of so many Americans in a cost effective manner not previously available in the US. Every day we hear more stories from dental professionals about how Advantage Arrest is not only helping so many of their patients but also how it is improving their practices by providing an effective and efficient way to treat this serious and rampant disease.”
The phase III study will provide the necessary data required by the Food and Drug Administration (FDA) for approving a cavity arrest drug claim in the US. It will closely follow 1,060 children, ages 2- 5, in preschool programs such as Head Start during a school year. The principal investigator is Dr. Margherita Fontana, a professor in the Department of Cariology, Restorative Sciences and Endodontics at the University of Michigan. Researchers from the University of Iowa, New York University, Indiana University, University of Otago in New Zealand, University of Hong Kong and University of Baltimore will also participate in this multi-center study.