Restorative Treatment in First Molars Affected by Molar-Incisor Hypomineralization

NCT ID: NCT02717286

Last Updated: 2016-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-10-31

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%).

Conditions

Molar Incisor Hypomineralization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

restorative

Intervention Type: PROCEDURE

It was performed direct restoration using two kinds of adhesive system (total-etching adhesive and self-etching adhesive)

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.

Group Type: EXPERIMENTAL

restorative

Intervention Type: PROCEDURE

It was performed direct restoration using two kinds of adhesive system (total-etching adhesive and self-etching adhesive)

Interventions

restorative

It was performed direct restoration using two kinds of adhesive system (total-etching adhesive and self-etching adhesive)

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Federal do Paraná

OTHER

Sponsor Role: lead

Responsible Party

Juliana Feltrin de Souza Caparroz

Juliana Feltrin de Souza

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rita de Cássia Loiola Cordeiro, PhD

Role: STUDY_CHAIR

UNESP- Univ Estadual Paulista

Locations

UNESP - Univ. Estadual Paulista

Araraquara, São Paulo, Brazil

Countries

Brazil

Other Identifiers

UFParana

Identifier Type: -

Identifier Source: org_study_id