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Restoration Quality in Molars Affected by Molar Incisor Hypo Mineralization

Primary Purpose

Molar Incisor Hypomineralization

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)
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 SexesAccepts Healthy Volunteers

Inclusion Criteria:

.Children with molar incisor hypo mineralization 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

    bulk-fill composite (Filtek BulkFlow, 3M Espe) will be used and covered using a nanohybrid composite, (Filtek XT, 3M Espe)

    preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)

    Outcomes

    Primary Outcome Measures

    pain after the restoration .Binary (yes or No)
    questionnaire

    Secondary Outcome Measures

    Acceptability of the treatment Binary (yes or No)
    questionnaire
    restoration quality Score index
    (FDI criteria; criterion marginal adaptation)
    health-related quality of life changes by the therapies
    measured as difference in Child Perceptions Questionnaire CPQ 8-10/11-14)

    Full Information

    First Posted
    July 31, 2019
    Last Updated
    July 14, 2020
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04475419
    Brief Title
    Restoration Quality in Molars Affected by Molar Incisor Hypo Mineralization
    Official Title
    Restoration Quality in Molars Affected by Molar-incisor-hypomineralization Using Composite Restorations or Preformed Metal Crowns: Two-arm Randomized Controlled Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2020 (Anticipated)
    Primary Completion Date
    December 31, 2020 (Anticipated)
    Study Completion Date
    December 31, 2020 (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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Restoration quality of molars affected by MIH using two different types of restorations direct composite and preformed crowns
    Detailed Description
    MIH or molar incisor hypomineralization is one of the difficult clinical situations to be managed by dentists the aim of this study is to specify which is the better treatment among composite restorations and preformed crowns in terms of gingival health patient satisfaction pain hypersensetivity acceptability by the patienat hypersensetivity and the need for future retreatment

    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
    Model Description
    parallel groups
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Direct composite restorations
    Arm Type
    Active Comparator
    Arm Description
    bulk-fill composite (Filtek BulkFlow, 3M Espe) will be used and covered using a nanohybrid composite, (Filtek XT, 3M Espe)
    Arm Title
    preformed metal crowns
    Arm Type
    Active Comparator
    Arm Description
    preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)
    Intervention Type
    Procedure
    Intervention Name(s)
    preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)
    Intervention Description
    covering the affected molar with preformed metal crown cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)
    Primary Outcome Measure Information:
    Title
    pain after the restoration .Binary (yes or No)
    Description
    questionnaire
    Time Frame
    12 MONTHS
    Secondary Outcome Measure Information:
    Title
    Acceptability of the treatment Binary (yes or No)
    Description
    questionnaire
    Time Frame
    12 months
    Title
    restoration quality Score index
    Description
    (FDI criteria; criterion marginal adaptation)
    Time Frame
    12 months
    Title
    health-related quality of life changes by the therapies
    Description
    measured as difference in Child Perceptions Questionnaire CPQ 8-10/11-14)
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: .Children with molar incisor hypo mineralization 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
    Eman m elmasry, PHD
    Phone
    01001651946
    Ext
    12345
    Email
    Mahmoued_dentist3@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    osama M alshahawy, master
    Phone
    01001651946
    Ext
    12345
    Email
    Mahmoued_dentist3@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    manalf M elshiekh, MASTER
    Organizational Affiliation
    CU
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Restoration Quality in Molars Affected by Molar Incisor Hypo Mineralization

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