Restorative Treatment in First Molars Affected by Molar-Incisor Hypomineralization

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

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.

Study Overview

• Status: Completed
• Conditions: Molar Incisor Hypomineralization
• Intervention / Treatment: Procedure: restorative

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Araraquara, SP, Brazil, 14801-903
      • UNESP - Univ. Estadual Paulista

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 8 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control; 20 first permanent molars from children aged between 6 to 12 years old presenting MIH will be included. A calibrated pediatric dentist examined the selected teeth to classify MIH according to the European Academy of Pediatric Dentistry (EADP) criteria. Intervention of Control: The restorative treatment using a total-etching adhesive system, which was performed according to the following operative sequence: prophylaxis, infiltrative anesthesia, rubber dam, application of 37.5% phosphoric acid to enamel (30 s) and dentine (15 s), extensive washing, drying with cotton and air jet (5 s), priming (5 s), light curing (20 s), restoration with composite resin (Filtek XT350), examination of occlusal contact, and final polishing.	Procedure: restorative; It was performed direct restoration using two kinds of adhesive system (total-etching adhesive and self-etching adhesive)
Experimental: Test; 20 first permanent molars from children aged between 6 to 12 years old presenting Molar Incisor Hypomineralization will be included. A calibrated pediatric dentist examined the selected teeth to classify MIH according to the EAPD criteria. Intervention of test: the restorative treatment using a self-etching adhesive system, which was performed according to the following operative sequence: prophylaxis, infiltrative anesthesia, rubber dam, application of 37.5% phosphoric acid to enamel (30 s) and dentine (15 s), extensive washing, drying with cotton and air jet (5 s), priming (5 s), air jet (5 s), adhesive application (5 s), light curing (20 s), restoration with composite resin (Filtek XT350), examination of occlusal contact, and final polishing.	Procedure: restorative; It was performed direct restoration using two kinds of adhesive system (total-etching adhesive and self-etching adhesive)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Survival rates of the direct restorative treatment	6 months

Collaborators and Investigators

• Sponsor: Universidade Federal do Paraná
• Investigators: Study Chair: Rita de Cássia Loiola Cordeiro, PhD, UNESP- Univ Estadual Paulista

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: March 18, 2016
• First Submitted That Met QC Criteria: March 18, 2016
• First Posted (Estimate): March 23, 2016

Study Record Updates

• Last Update Posted (Estimate): March 30, 2016
• Last Update Submitted That Met QC Criteria: March 28, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Tooth Abnormalities; Dental Enamel Hypoplasia
• Other Study ID Numbers: UFParana

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES