Survival of GIC or CR restorations in molars fractured by MHI - randomized clinical study

• Grant number: 24/07737-3
• Support Opportunities: Scholarships in Brazil - Master
• Start date: October 01, 2024
• End date: July 31, 2026
• Field of knowledge: Health Sciences - Dentistry - Pediatric Dentistry
• Principal Investigator: Daniela Rios Honório
• Grantee: Bianca Longo Polo
• Host Institution: Faculdade de Odontologia de Bauru (FOB). Universidade de São Paulo (USP). Bauru , SP, Brazil

Abstract

Molar incisor hypomineralization (MIH) is a qualitative enamel defect that affects the first permanent molars and, occasionally, the permanent incisors. Due to reduced mineral content and increased organic material, clinically, there will be demarcated opacities of cream-white or yellow-brown color, which are susceptible to post-eruptive fractures under mechanical impacts. The restoration of these fractures presents limitations due to the difficulty in adhering restorative materials to hypomineralized tissue. The current scientific literature lacks evidence on the comparative clinical survival of restorative materials in these cases. Thus, this study aims to evaluate the survival of restorations made with glass ionomer cement (Equia Forte®) or composite resin (Clearfil SE Bond®+ Filtek Z350XT®) over 12 months, as well as to analyze the quality of life of patients before and after the procedures, and the satisfaction of patients and their guardians. The study will be conducted in a randomized, controlled, parallel, and double-blind manner (evaluator and participant). Individuals aged 6 to 14 years with at least one first permanent molar affected by MIH and with a post-eruptive fracture involving up to three surfaces, without compromising more than half of the coronal area that receives occlusal impact, will be selected. Participant randomization will be carried out in a stratified manner following the characteristics of the fracture extension. Before the restorations of the respective groups are performed, a questionnaire will be administered to assess the child's quality of life. After the restorations, the questionnaire will be re-administered, and a satisfaction questionnaire for the child and their guardians will also be applied. Evaluators will check the survival of the restorations at 6 and 12 months using USPHS and ART criteria. The survival data of the restorations will be analyzed using the Kaplan-Meier statistical test, and the secondary outcomes will be analyzed through two-way repeated measures ANOVA (p<0.05).