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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369768
Recruitment Status : Not yet recruiting
First Posted : April 30, 2020
Last Update Posted : July 20, 2020
Sponsor:
Information provided by (Responsible Party):
Sandra Nasr Fares, Cairo University

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.

Condition or disease Intervention/treatment Phase
Molar Incisor Hypomineralization Procedure: restoration of permanent molars affected with MIH Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
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 I)
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : August 2021

Arm Intervention/treatment
Active Comparator: direct composite restorations Procedure: restoration of permanent molars affected with MIH
restore MIH affected molars using direct composite or preformed metal crowns

Active Comparator: preformed metal crowns Procedure: restoration of permanent molars affected with MIH
restore MIH affected molars using direct composite or preformed metal crowns




Primary Outcome Measures :
  1. treating hypersensitivity associated with MIH affected permanent molars by questioning the patient [ Time Frame: one year ]
    questioning the patient about hypersensitivity after performing treatment ( direct composite restorations and preformed metal crowns)



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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369768


Contacts
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Contact: Sandra Nasr Fares 01225167030 dr.sandra.nasr@gmail.com

Sponsors and Collaborators
Cairo University
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Responsible Party: Sandra Nasr Fares, Dr. Sandra Nasr Fares, Cairo University
ClinicalTrials.gov Identifier: NCT04369768    
Other Study ID Numbers: MIH restoration
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dental Enamel Hypoplasia
Tooth Abnormalities
Stomatognathic System Abnormalities
Stomatognathic Diseases
Tooth Diseases
Congenital Abnormalities