This SBIR Phase I proposal requests $178,410.00 (total cost) support for Advantage Silver DentalArrest, LLC. to develop and assess the technical and scientific feasibility of High Fluoride Toothpaste that alsocontains Povidone Iodine as a commercial product to arrest dental caries. This proposal responds to theNIDCR Preclinical Research topic: "Preclinical research and development activities for dental and craniofacialtechnologies (including devices, diagnostic instruments, reconstructive materials, pharmaceuticals,therapeutics, vaccines, and biologics) that require review and approval by the FDA as a regulated productbefore commercial distribution". The aims: 1) To develop a fluoride toothpaste that also contains PVP-I, assure stability, anddemonstrate release of fluoride and iodine from its matrix; 2) To assess antibacterial activity of newlyformulated toothpaste that contains both fluoride and PVP-I against caries causing bacteria, and to assesswhether these agents act in synergistic, merely additive, or antagonistic fashion; and 3) To assess whetherformulations of the toothpaste shown by the work of aim 2 persist in both inhibition of de-mineralization ofenamel and also persist in fostering re-mineralization of enamel. The high fluoride antimicrobial toothpaste envisioned by Advantage Silver Dental Arrest, LLC builds onthe currently available prescription high fluoride toothpastes but for which the available evidence of effectivenessis limited, yet their use appears to be growing. Researchers for some time have suggested that combining topicalantiseptics to control tooth surface colonization by cariogenic bacteria with fluoride that primarily remineralizesenamel has promise. The new prescription toothpaste will be inexpensive, easy to use, and well tolerated bypatients of all ages and special needs. This effort brings partners with a strong record in materials physics, microbiology, caries research andpublic health together with oral care industry partners who have a history of successfully bringing products tomarket. 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; toothpaste
Public Health Relevance Statement: PROJECT 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.
Project Terms: Adult ; 21+ years old ; Adult Human ; adulthood ; Age ; ages ; Local Anti-Infective Agents ; Antiseptics ; Local Antiinfective Agents ; Topical Anti-Infective Agents ; Topical Antiinfective Agents ; Bacteria ; Child ; 0-11 years old ; Child Youth ; Children (0-21) ; youngster ; Clinical Trials ; Color ; Dental caries ; Caries ; Dental Decay ; tooth decay ; Dental Enamel ; Enamel ; tooth enamel ; Disease ; Disorder ; Fluorides ; Topical Fluorides ; Goals ; Recording of previous events ; History ; Hylobates Genus ; Gibbons ; Hylobates ; Nomascus ; Symphalangus ; In Vitro ; Indiana ; Iodine ; Masks ; Methods ; Microbiology ; United States National Institutes of Health ; NIH ; National Institutes of Health ; Patients ; Physics ; Povidone-Iodine ; Betadine ; PVP-I ; PVP-Iodine ; Polyvinylpyrrolidone Iodine ; Public Health ; Request for Proposals ; Research ; research and development ; Development and Research ; R & D ; R&D ; Research Personnel ; Investigators ; Researchers ; Research Support ; Silver ; Ag element ; Sodium Fluoride ; Streptococcus ; Streptococcus mutans ; S mutans ; S. mutans ; Supervision ; Taste Perception ; Gustation ; Taste ; gustatory perception ; gustatory processing ; gustatory response ; taste processing ; taste response ; Technology ; Time ; deciduous tooth ; Primary Tooth ; Temporary Tooth ; Toothpaste ; United States ; Universities ; Vaccines ; Varnish ; Work ; Businesses ; base ; Phase ; Biological ; Adolescent ; Adolescent Youth ; juvenile ; juvenile human ; Dental ; Fostering ; Anti-Bacterial Agents ; Antibacterial Agents ; anti-bacterial ; antibacterial ; Collaborations ; Letters ; Therapeutic ; instrument ; Diagnostic ; Adult Dentition ; Permanent Dentition ; Secondary Dentition ; permanent tooth ; programs ; tooth surface ; craniofacies ; craniofacial ; experience ; oral flora ; oral bacteria ; synergism ; aqueous ; Devices ; Modeling ; Pharmaceutical Agent ; Pharmaceuticals ; Pharmacological Substance ; Pharmacologic Substance ; Effectiveness ; preventing ; prevent ; Causality ; causation ; disease causation ; Etiology ; Address ; NIDCR ; NIDR ; National Institute of Dental Research ; National Institute of Dental and Craniofacial Research ; New Agents ; Small Business Innovation Research Grant ; SBIR ; Small Business Innovation Research ; Modification ; preclinical study ; pre-clinical study ; remineralization ; mineralization ; cariogenic bacteria ; oral care ; cost ; reconstruction ; topical antiseptic ; Caries prevention ; dental caries prevention ; pathogen ; antimicrobial ; anti-microbial ; pre-clinical research ; preclinical research ; FDA approved ; industry partner ; industrial partnership ; industry partnership ; Healthy People 2020 ; Formulation ; high risk population ; high risk group ;
