12-month evaluation of restorations with "bioactive" material in patients that underwent head and neck cancer treatment: double-blind, controlled and randomized clinical trial.

• Grant number: 24/13984-3
• Support Opportunities: Scholarships in Brazil - Master
• Start date: May 01, 2025
• End date: February 28, 2026
• Field of knowledge: Health Sciences - Dentistry - Dental Materials
• Principal Investigator: Marcelo Giannini
• Grantee: Luana de Melo Soares
• Host Institution: Faculdade de Odontologia de Piracicaba (FOP). Universidade Estadual de Campinas (UNICAMP). Piracicaba , SP, Brazil

Abstract

This research project comprises a clinical study to evaluate the performance of Class V restorations (carious cervical lesions) using a "bioactive" resin composite (Beautifil II, Shofu Inc.) in patients submitted to treatment for head and neck cancer. Restorations with a regular resin composite without "bioactivity" (NeoSpectra ST, Dentsply Sirona) will be used as a Control. The restorations will be evaluated after one week, 6 months and one year according to mechanical properties (retention rate, fracture and marginal adaptation), aesthetic properties (color change and marginal staining) and biological properties (post-operative sensitivity and recurrent caries). The World Dental Federation (FDI) and/or the modified US Public Health Service (USPHS) criterias will be used for evaluation of the restorative procedure and adjacent dental structure. To assess inter-examiner reliability, the Cohen Kappa statistical test will be used. Pearson's Chi-square test will be used to compare the differences among scores for each parameter. Additionally, "in vitro" bond strength tests will be performed on enamel and dentin, using the same restorative materials on extracted teeth from patients that underwent head and neck cancer treatment.