Evaluation of the protective potential of CaneCPI-5, associated or not with fluoride, in the prevention of demineralization and remineralization of artificial carious lesions: in situ study

• Grant number: 25/10757-9
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: August 01, 2025
• End date: July 31, 2026
• Field of knowledge: Health Sciences - Dentistry - Social and Preventive Dentistry
• Principal Investigator: Tamara Teodoro Araujo
• Grantee: Giulia Tiba Ruiz
• Host Institution: Faculdade de Odontologia de Bauru (FOB). Universidade de São Paulo (USP). Bauru , SP, Brazil

Abstract

The project aims to investigate the effects of CaneCPI-5, with or without fluoride, on the prevention of enamel demineralization and the remineralization of artificial enamel lesions in an in situ model. Initially, bovine enamel samples (4 mm x 4 mm, n=320) will be polished and subjected to initial surface microhardness analysis (5 Knoop indentations, 25 g, 10s) and roughness assessment. Half of the samples will remain sound, while the other half will be demineralized using a microcosm biofilm model for 5 days. Twenty healthy volunteers will be recruited to participate in the study. Their dental arches will be molded to fabricate intraoral appliances, in which four bovine enamel samples will be inserted under two conditions: two pre-demineralized samples placed flush with the acrylic resin to prevent biofilm accumulation, promoting remineralization, and two samples inserted 1.5 mm below the appliance surface, protected with a plastic mesh to allow biofilm accumulation and exposed to 20% sucrose eight times per day to promote demineralization. Volunteers will undergo four double-blind, crossover phases: Phase A, using CaneCPI-5 (0.1 mg/mL), which showed the best results in an in vitro study; Phase B, using a fluoridated solution (NaF, 500 mg/L); Phase C, using CaneCPI-5 (0.1 mg/mL) combined with a fluoridated solution (NaF, 500 mg/L); and Phase D, using deionized water as a control. The solutions will be applied as mouth rinses (10 mL, twice for 1 minute per day) while the appliance is positioned in the mouth, before the first cariogenic challenge and after the last cariogenic challenge of the day. During the experiment, volunteers will wear the intraoral appliances for specific periods of 7 days per phase, with a 7-day washout period between phases to prevent sample contamination. The appliance will remain in the mouth and will only be removed during the three main meals. Volunteers will apply one drop of 20% sucrose solution for 5 minutes to the samples corresponding to this condition, after which the appliance will be repositioned in the mouth. At the end of the experiment, the demineralization of the samples will be analyzed using three-dimensional transverse microradiography (TMRD-3D). Data will be checked for normality and homogeneity to determine the appropriate statistical test, either parametric or non-parametric, with a significance level of p < 0.05. (AU)