Evaluation of a low-fluoride anticaries toothpaste containing an innovative calci

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DESCRIPTION (provided by applicant): A recent clinical research report on children found that over a two-year period although there was no statistical differences in anticaries benefits between two groups using either 1000 ppm F or 400 to 550 ppm F toothpastes, there was a directional trend of caries incidence increasing with lower fluoride toothpastes. Nevertheless clinical data demonstrate caries progression increases over time when lower fluoride toothpastes are used. The same research report discussed above also found the prevalence of dental fluorosis was dramatically higher for users of a 1000 ppm F toothpaste compared to users of toothpaste containing between 400 and 550 ppm F. Separately, adults not wishing to use a normal over-the-counter (OTC) level of fluoride but still desiring the same, if not better, anticaries benefits in a product having less fluoride do not currently have an efficacious option. This continues to be a very sensitive issue among the general population as well as scientific researchers, and in fact there exists an entire peer-reviewed journal (Fluoride) that contains many publications on the ill-effects produced by fluoride. Until an effective alternative is found, such contention and debate will continue. Simply increasing the level of fluoride in an oral delivery system, such as toothpaste, is not the answer, especially if one considers the potential risks of dental fluorosis. As such, there is an opportunity to provide anticaries benefits without compromising the health of the dentition. Published studies reveal that multi-mineral treatments, including fluoride, calcium, and phosphorous can act synergistically to provide enhanced levels for protection compared to single mineral treatments. With over 95% of the US population brushing their teeth daily, toothpastes are the most widely used and accepted form of topical fluoride treatment. In order to reduce potential dental fluorosis risks without compromising anticaries benefits, the development of a multi-mineral toothpaste formulation that contains lower levels of fluoride (i.e. ~ 500 ppm F) relative to existing OTC fluoride toothpastes may be possible if other fluoride-compatible tooth-building minerals could be included in the formulation. Such a formulation would be targeted specifically for children and adults as a safe and effective alternative to create significant value and provide a significant public health benefit. Indiana Nanotech has patent-pending technology for a unique fluoride-compatible functionalized tricalcium phosphate (fTCP). By building on our current knowledge, experience, and success with the fTCP technology, in this SBIR Phase I proposal we seek to determine the feasibility of formulating a low fluoride plus fTCP toothpaste that provides anticaries efficacy at least as good as an established OTC fluoride toothpaste. We have partnered with a leading FDA-approved and cGMP compliant dentifrice manufacturer and a renowned university to address the following Specific Aims: 1) Formulation of three toothpastes: fluoride-free (placebo); one with 500 ppm fluoride; one with 500 ppm fluoride plus fTCP; 2) Execution of laboratory studies that include a battery of FDA-recommended laboratory studies, including fluoride bioavailability, enamel fluoride uptake, and white-spot lesion reversal via remin/demin cycling.; and 3) The clinical evaluation in a double-blind cross-over in situ clinical study. PUBLIC HEALTH RELEVANCE: Clinical data demonstrate caries progression increases over time when toothpastes are used containing lower levels fluoride relative to that found in over-the-counter (OTC) toothpaste (~ 1100 ppm fluoride). But children and adults not wishing to use OTC toothpaste but still desiring at least the same, if not better, anticaries benefits from a toothpaste having less fluoride do not currently have an efficacious option. In order to reduce potential dental fluorosis risks without compromising anticaries benefits, the development of a multi-mineral toothpaste formulation that contains lower levels of fluoride (i.e. ~ 500 ppm F) relative to existing OTC fluoride toothpastes may be possible by combining Nanotech's innovative fluoride-compatible tooth-building minerals could be included in the formulation. Such a formulation would be targeted specifically for children and adults as a safe and effective alternative to create significant value and provide a significant public health benefit.