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Completed

NCT Number: NCT02717286

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.

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Key information

Conditions

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

Age range

6 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNESP - Univ. Estadual Paulista

Araraquara, São Paulo, 14801-903, Brazil

About this study

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%).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

restorative

Procedure

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

Primary outcomes

  1. Survival rates of the direct restorative treatment

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Universidade Federal do Paraná

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2015
First posted
Mar 23, 2016
Registry last updated
Mar 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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