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Development of inovative formulations to optimize the efficacy and safety of dental bleaching

Abstract

The aim of this study will be to develop, test and validate, through in vitro and in vivo studies, a dental bleaching gel based on hydrogen peroxide or non-peroxide active agent for in-office use, containing bioactive particles and chemical catalysis. To reach this objective, different thickening agents will be tested for their deleterious effects on tooth structure. The most suitable will be associated with the active agent (hydrogen peroxide, PAP and chlorine dioxide) and other components, such as alkalizing agents, surfactants, humectants, dyes, catalysts, and bioactive particles. Tests regarding safety, efficacy, and stability by adding each component to the formulation will be performed during the development process. The resulting product will be compared with others with the same indication, with respect to gel characteristics, bleaching efficacy, change in surface gloss, pulp penetration of peroxide and formation of free radicals, cytotoxic effects on pulp cells, enamel demineralization capacity, changes on the organic content, changes in morphology and on enamel surface roughness, changes on the hydraulic conductance, postoperative sensitivity and other aspects related to the clinical applicability of the product. The effect of the treatment on protection against demineralization resulting from cariogenic and erosive challenges will also be tested. The data obtained from the comparison with commercial products will be statistically analyzed, using the most appropriate tests for each situation, considering the type of variable, in addition to their normality and homoscedasticity. The formulation developed will be patented with the support of the Unesp Innovation Agency (AUIN), and the results will be published in international scientific journals with a high impact factor. The project is being submitted to the São Paulo Research Foundation - FAPESP, and a research grant will be requested through a Thematic Project. Undergraduate and graduate students and professors from the host institution and other universities in the state of São Paulo will participate of the project, as well as international researchers through the exchange of Brazilian students with partner universities abroad. (AU)

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