SCIENTIFIC FEASIBILITY OF HIGH FLUORIDE-POVIDONE IODINE TOOTHPASTE

ABSTRACTThis SBIR Phase I proposal requests $178,410.00 (total cost) support for Advantage Silver Dental Arrest, LLC. to develop and assess the technical and scientific feasibility of High Fluoride Toothpaste that also contains Povidone Iodine as a commercial product to arrest dental caries. This proposal responds to the NIDCR Preclinical Research topic: “Preclinical research and development activities for dental and craniofacial technologies (including devices, diagnostic instruments, reconstructive materials, pharmaceuticals, therapeutics, vaccines, and biologics) that require review and approval by the FDA as a regulated product before commercial distribution”.The aims: 1) To develop a fluoride toothpaste that also contains PVP-I, assure stability, and demonstrate release of fluoride and iodine from its matrix; 2) To assess antibacterial activity of newly formulated toothpaste that contains both fluoride and PVP-I against caries causing bacteria, and to assess whether these agents act in synergistic, merely additive, or antagonistic fashion; and 3) To assess whether formulations of the toothpaste shown by the work of aim 2 persist in both inhibition of de-mineralization of enamel and also persist in fostering re-mineralization of enamel.The high fluoride antimicrobial toothpaste envisioned by Advantage Silver Dental Arrest, LLC builds on the currently available prescription high fluoride toothpastes but for which the available evidence of effectiveness is limited, yet their use appears to be growing. Researchers for some time have suggested that combining topical antiseptics to control tooth surface colonization by cariogenic bacteria with fluoride that primarily remineralizes enamel has promise. The new prescription toothpaste will be inexpensive, easy to use, and well tolerated by patients of all ages and special needs.This effort brings partners with a strong record in materials physics, microbiology, caries research and public health together with oral care industry partners who have a history of successfully bringing products to market. The size of the United States topical fluoride market is estimated to total $185 - $205 million annually. We conservatively expect to capture between 5% and 10% of the U.S market 3 years post FDA approval. Key words: dental caries; sodium fluoride; povidone-iodine; toothpastePROJECT NARRATIVE Dental caries (tooth decay) is a common disease. Advantage Silver Dental Arrest, LLC. proposes to conduct studies to develop and assess the technical and scientific feasibility of High Fluoride Toothpaste also containing Povidone Iodine as a commercial product to prevent dental caries. The new agent builds on an FDA-cleared 1.1% NaF toothpaste but takes advantage of likely synergy with PVP-I. The new toothpaste will be inexpensive, easy to use, and well tolerated by patients of all ages and special needs. This research addresses Healthy People 2020 objectives OH-1 Reduce the proportion of children and adolescents who have dental caries experience in their primary or permanent teeth and OH-3 Reduce the number of adults with untreated dental decay.