Restorative Treatment in First Molars Affected by Molar-Incisor Hypomineralization

Molar Incisor Hypomineralization Clinical Trial

Official title: Survival of Restorative Treatment in First Molars Affected by Molar-Incisor Hypomineralization

Status Completed

Clinical Trial Summary

The restorative management of molars with Molar-Incisor Hypomineralization (MIH) represents a challenge in the clinical practice with high failure rate. Thus, this clinical trial aimed to evaluate the clinical survival of direct composite resin restorations in first permanent molars (FPMs) that are affected by MIH, comparing two adhesive systems.

Clinical Trial Description

For the research, it was selected first permanent molars (FPMs) with MIH from children aged 6-8 years. FPM fully erupted and with restorative treatment needed was the inclusion criteria. We excluded FPMs with destroyed crowns. The FPMs were randomly assigned to two groups: G1 (self-etching adhesive) and G2 (total-etching adhesive). Clinical evaluation was performed during 18 months according to the USPHS-Modified by a blinded examiner. The actuarial method was used to evaluate survival of the restorations and Fisher's exact test was used to compare differences between the groups (α=5%). ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Enamel Hypoplasia
• Molar Incisor Hypomineralization

• NCT number: NCT02717286
• Study type: Interventional
• Source: Universidade Federal do Paraná
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Completion date: October 2015