Restorative Treatment in First Molars Affected by Molar-Incisor Hypomineralization

NCT02717286 | Completed DMC

• 1 other identifier: UFParana
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Molar Incisor Hypomineralization

Outcome Measures

Primary Outcomes (1)

• Survival rates of the direct restorative treatment

  6 months

Study Arms (2)

Control

SHAM COMPARATOR

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

Test

EXPERIMENTAL

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

Interventions

restorative PROCEDURE

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

Control; Test

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Paraná: lead

Study Sites (1)

UNESP - Univ. Estadual Paulista

Araraquara, São Paulo, 14801-903, Brazil

Location

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Rita de Cássia Loiola Cordeiro, PhD

  UNESP- Univ Estadual Paulista

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Juliana Feltrin de Souza

Study Record Dates

• First Submitted: March 18, 2016
• First Posted: March 23, 2016
• Study Start: January 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2015
• Last Updated: March 30, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)