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Restorative Treatment in First Molars Affected by Molar-Incisor Hypomineralization

Primary Purpose

Molar Incisor Hypomineralization

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
restorative
Sponsored by
Universidade Federal do Paraná
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Molar Incisor Hypomineralization

Eligibility Criteria

6 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • UNESP - Univ. Estadual Paulista

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Control

Test

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Survival rates of the direct restorative treatment

Secondary Outcome Measures

Full Information

First Posted
March 18, 2016
Last Updated
March 28, 2016
Sponsor
Universidade Federal do Paraná
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1. Study Identification

Unique Protocol Identification Number
NCT02717286
Brief Title
Restorative Treatment in First Molars Affected by Molar-Incisor Hypomineralization
Official Title
Survival of Restorative Treatment in First Molars Affected by Molar-Incisor Hypomineralization
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Paraná

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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%).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Molar Incisor Hypomineralization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Test
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
restorative
Intervention Description
It was performed direct restoration using two kinds of adhesive system (total-etching adhesive and self-etching adhesive)
Primary Outcome Measure Information:
Title
Survival rates of the direct restorative treatment
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rita de Cássia Loiola Cordeiro, PhD
Organizational Affiliation
UNESP- Univ Estadual Paulista
Official's Role
Study Chair
Facility Information:
Facility Name
UNESP - Univ. Estadual Paulista
City
Araraquara
State/Province
SP
ZIP/Postal Code
14801-903
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Restorative Treatment in First Molars Affected by Molar-Incisor Hypomineralization

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