Phase II RCT of Advantage Anti-Cavity Varnish

ABSTRACT This Small Business Innovation Research Phase II proposal to NIH requests $ support for Advantage Silver Dental Arrest LLC to conduct a Phase II RCT to determine the efficacy of Advantage Anti Caries Varnish a combination povidone iodine sodium fluoride varnish with the primary outcome of dental caries increment at years post baseline This proposal responds to NIDCR research topics F Develop ways to interfere with microbial colonization and growth through the use of antimicrobial agents and chemotherapy Infectious Diseases and Immunity and D Develop and test for safety efficacy and or effectiveness of measures or materials for diagnosing preventing or treating oral dental and craniofacial conditions and disorders Clinical and Behavioral Research The significance is that the agent developed by Advantage Silver Dental Arrest LLC in Phase I builds on the current mainstay of caries prevention NaF varnish but adds a safe antibacterial agent that may prove synergistic with F and as a decay preventive modality varnish is inexpensive easy to use and well tolerated by patients of all ages and special needs This effort also brings research partners that have a strong track record in microbiology caries research and public health together with experienced oral care industry business partners who have a long history of successfully bringing products to market This research addresses Healthy People objective OH Reduce the proportion of children and adolescents who have dental caries experience in their primary or permanent teeth It also addresses Goals and of the NIDCR Strategic Plan The proposed work is innovative because the resulting product takes advantage of possible biological synergies and could change the standard of care Moreover because the FDA has granted an IND and a Phase I safety study has been conducted the product is ready for Phase II RCT An easy to use single product will speed dissemination and reduce barriers to adoption The size of the United States topical fluoride market is estimated to total $ $ million annually We conservatively expect to capture between and of the U S market years post FDA NDA approval Germany and Australia represent significant additional revenue opportunities due to their size their focus on preventive oral care reasonable costs of market entry and manageable regulatory hurdles Additional market opportunities outside the U S will also be explored and pursued where appropriate Key words dental caries sodium fluoride povidone iodine varnishPROJECT NARRATIVE Dental caries tooth decay is a common disease Advantage Silver Dental Arrest LLC proposes to conduct a Phase II RCT to determine the efficacy of Advantage Anti Caries Varnish a combination povidone iodine sodium fluoride varnish The new agent developed in Phase I builds on the current mainstay of caries prevention NaF varnish but adds a safe antibacterial agent that may prove synergistic with F As a decay preventive modality varnish is inexpensive easy to use and well tolerated by patients of all ages and special needs This research addresses Healthy People objective OH Reduce the proportion of children and adolescents who have dental caries experience in their primary or permanent teeth