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

Sponsor
Amal Ahmed Mohamed El Kot (Other)
Overall Status
Recruiting
CT.gov ID
NCT04654858
Collaborator
(none)
5
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Direct composite restorations
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
5 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Blinding to the child participants and legal guardian of each participating child, operator, outcome assessor and statistician.
Primary Purpose:
Treatment
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 II)
Anticipated Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Oct 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Direct composite restorations

bulk-fill composite (Filtek BulkFlow, 3M Espe) will be used after 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).

Procedure: Direct composite restorations
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

    		•
    Active Comparator: Performed metal crowns

    PMCs (3M Espe, Seefeld, Germany) will be placed after infiltration or block anaesthesia for affected molar, followed by removal of carious dentin and enamel, Tooth preparation for fitting the crown, The correct size of crown will be chosen, and then Cemented with glass ionomer luting cement (KetacCem, 3M Espe).

    Procedure: Direct composite restorations
    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Hypersensitivity [12 month]

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

    Secondary Outcome Measures

    1. Acceptability of the treatment [12 month]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Children with MIH in one fully erupted molar or more.

    2. Age ranging from 7-12 years.

    3. cooperative children

    4. Good general health.

    Exclusion Criteria:

    1. patients participating in other experiments.

    2. Patients with parents planning to move away within the following year.

    3. Patients with only mildly affected MIH molars that do not require extensive restorative treatment.

    4. MIH-affected molars that have a very poor prognosis and require extraction.

    5. First permanent molars that are affected with other developmental defects, such as hypoplasia, dental fluorosis or amelogenesis imperfecta.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Oral and Dental Medicine Cairo Egypt

    Sponsors and Collaborators

    • Amal Ahmed Mohamed El Kot

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Amal Ahmed Mohamed El Kot, doctor, Cairo University
    ClinicalTrials.gov Identifier:
    NCT04654858
    Other Study ID Numbers:
    • treatment of teeth with MIH
    First Posted:
    Dec 4, 2020
    Last Update Posted:
    Dec 4, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Amal Ahmed Mohamed El Kot, doctor, Cairo University
    MIH
    Additional relevant MeSH terms:
    Dental Enamel Hypoplasia

    Study Results

    No Results Posted as of Dec 4, 2020