Restorative Treatment in First Molars Affected by Molar-Incisor Hypomineralization

Not Applicable

Completed

• Conditions: Molar Incisor Hypomineralization

• Registration Number: NCT02717286
• Lead Sponsor: Universidade Federal do Paraná

Brief 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.

Detailed 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 Timeline

• Study Start: 2013-01
• Primary Completion: 2013-10
• Study Completion: 2015-10
• Status Verified: 2016-03
• Study First Submitted: 2016-03-18
• Study First Submitted QC: 2016-03-18
• Study First Posted: 2016-03-23
• Last Update Submitted: 2016-03-28
• Last Update Posted: 2016-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• children and/or parents who agree in participate of the study
• children were born and living in Araraquara, SP, Brazil
• presence of the first permanent molars totally erupted with defects classified as enamel post eruptive breakdown (PEB) or unsatisfactory atypical restoration (UATR), with or without carious lesions.

Exclusion Criteria

• children and/or parents who do not agree in participate of the study
• first permanent molars with enamel malformation associated with syndromes,
• dental fluorosis,
• first permanent molars with destroyed crowns,
• imperfect amelogenesis
• fixed orthodontic appliances.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Survival rates of the direct restorative treatment	6 months

Trial Locations

Locations (1)

UNESP - Univ. Estadual Paulista; 🇧🇷 Araraquara, SP, Brazil