Restorative Treatment in First Molars Affected by Molar-Incisor Hypomineralization

Molar Incisor Hypomineralization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02717286
• Other study ID #: UFParana
• Status: Completed
• Phase: N/A
• First received: March 18, 2016
• Last updated: March 28, 2016
• Start date: January 2013
• Est. completion date: October 2015

Study information

• Verified date: March 2016
• Source: Universidade Federal do Paraná
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 2015
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 8 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Enamel Hypoplasia
• Molar Incisor Hypomineralization

Intervention

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

Locations

Country	Name	City	State
Brazil	UNESP - Univ. Estadual Paulista	Araraquara	SP

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Paraná

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rates of the direct restorative treatment		6 months	Yes