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Completed

NCT Number: NCT04654858

Restoration of Permanent Molars Affected With (MIH) Using Composite Restorations or Preformed Metal Crowns

The aim of this study is to compare the clinical outcome of using direct esthetic composite restorations in managing MIH cases and the use of preformed metal crowns.

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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

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Oral and Dental Medicine

Cairo, Egypt

About this study

Molar incisor hypomineralization can represent a serious and challenging clinical management problem. Children with MIH require higher levels of treatment needs and demonstrate considerable management problems.

For most severely affected MIH molars, direct esthetic restorative materials or preformed metal crowns will be the treatments to choose between. A number of aspects which could support decision-making, however, are not clearly demarcated. First and foremost, it is not clear if both treatments are similarly acceptable for patients and providers.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children with MIH in one fully erupted molar or more.
  • Age ranging from 7-12 years.
  • cooperative children
  • Good general health.

Exclusion criteria

  • patients participating in other experiments.
  • Patients with parents planning to move away within the following year.
  • Patients with only mildly affected MIH molars that do not require extensive restorative treatment.
  • MIH-affected molars that have a very poor prognosis and require extraction.
  • First permanent molars that are affected with other developmental defects, such as hypoplasia, dental fluorosis or amelogenesis imperfecta.

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Treatment and study plan

Direct composite restorations

Procedure

bulk-fill composite (Filtek BulkFlow, 3M Espe) will be used aftar infiltration or block anaesthesia for affected molar,following by carious tissue removal. Marginal bevelling of enamel will be performed. A universal adhesive (Scotchbond Universal, 3M Espe) will be placed after selective enamel etching A bulk-fill composite will be used and covered using a nanohybrid composite, (Filtek XT, 3M Espe).

Other names: composite resin

Primary outcomes

  1. Hypersensitivity

    Time frame: 12 month

    Questioning the patient and/or the parent (Clemenus et al,2017) Binary (yes, no)

Secondary outcomes

  1. Acceptability of the treatment

    Time frame: 12 month

    Questioning the children or parents about accepting the treatment Binary (Yes or No)

Sponsors and collaborators

Lead sponsor

Amal Ahmed Mohamed El Kot

Other

Registry information

Official study title

Restoration of Permanent Molars Affected With Molar-incisor-hypomineralization (MIH) Among a Group of Egyptian Children Using Composite Restorations or Preformed Metal Crowns: Two-arm Randomized Controlled Trial (Part II)

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 4, 2020
Registry last updated
Feb 6, 2024

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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