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Restoration of Permanent Molars Affected With Molar-incisor-hypomineralization (MIH) Among a Group of Egyptian Children Using Composite Restorations or Preformed Metal Crowns

Primary Purpose

Molar Incisor Hypomineralization

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
restoration of permanent molars affected with MIH
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Molar Incisor Hypomineralization

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    direct composite restorations

    preformed metal crowns

    Arm Description

    Outcomes

    Primary Outcome Measures

    treating hypersensitivity associated with MIH affected permanent molars by questioning the patient
    questioning the patient about hypersensitivity after performing treatment ( direct composite restorations and preformed metal crowns)

    Secondary Outcome Measures

    Full Information

    First Posted
    April 28, 2020
    Last Updated
    July 17, 2020
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04369768
    Brief Title
    Restoration of Permanent Molars Affected With Molar-incisor-hypomineralization (MIH) Among a Group of Egyptian Children Using Composite Restorations or Preformed Metal Crowns
    Official 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 I)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2020 (Anticipated)
    Primary Completion Date
    July 2021 (Anticipated)
    Study Completion Date
    August 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The aim of this study is to compare the clinical outcome of using direct esthetic composite restorations and the use of preformed metal crowns in managing MIH cases among a group of Egyptian children.

    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
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    direct composite restorations
    Arm Type
    Active Comparator
    Arm Title
    preformed metal crowns
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    restoration of permanent molars affected with MIH
    Intervention Description
    restore MIH affected molars using direct composite or preformed metal crowns
    Primary Outcome Measure Information:
    Title
    treating hypersensitivity associated with MIH affected permanent molars by questioning the patient
    Description
    questioning the patient about hypersensitivity after performing treatment ( direct composite restorations and preformed metal crowns)
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sandra Nasr Fares
    Phone
    01225167030
    Email
    dr.sandra.nasr@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

    Restoration of Permanent Molars Affected With Molar-incisor-hypomineralization (MIH) Among a Group of Egyptian Children Using Composite Restorations or Preformed Metal Crowns

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