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A Comparison of Two Different Management Techniques for Extensive Molar Defects in Patients Suffering From MIH

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: NCT04209920
Recruitment Status : Recruiting
First Posted : December 24, 2019
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
Hagar Mahmoud Mohie, Ain Shams University

Brief Summary:
It is a randomized clinical trial in which two different types of full coverage restoration in used to restore hypomineralized first permanent molar and protect the remaining tooth structure in patients with molar incisor hypomineralization ,one group is covered with CAD-CAM milled poly methyl methacrylate crowns and the other group is covered with cast metal copings (CAC) using nickel chromium alloy and there will be a nine months follow up.

Condition or disease Intervention/treatment Phase
Molar Incisor Hypomineralization Device: CAD-CAM milled PMMA crown Other: Cast metal coping using nickel chromium alloy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: "A Comparison of Two Different Management Techniques for Extensive Molar Defects in Patients Suffering From Molar Incisor Hypomineralization (MIH)" (Randomized Clinical Trial)
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: PMMA crown Group
Hypomineralized first permanent molars in patients with molar incisor hypomineralization.
Device: CAD-CAM milled PMMA crown
the patient will receive a full coverage restoration for hypomineralized first permanent molar in patient suffering from molar incisor hypomineralization using PMMA disks using a CAD-CAM technology.

Active Comparator: Cast metal coping Group
Hypomineralized first permanent molars in patients with molar incisor hypomineralization.
Other: Cast metal coping using nickel chromium alloy
the patient will receive a full coverage restoration for hypomineralized first permanent molar in patient suffering from molar incisor hypomineralization using Nickel Chromium alloy to make a Cast Coping.




Primary Outcome Measures :
  1. Marginal Integrity [ Time Frame: 9 months follow up ]
    the crowns is evaluated radiographically using a bite wing radio graph for marginal extension integrity.

  2. Related quality of life: questionnaire [ Time Frame: 9 months ]
    A questionnaire about related quality of life of the patient to evaluate patient's satisfaction and comfort.

  3. Recurrent caries [ Time Frame: 9 months ]
    the tooth is evaluated radiographically using a bite wing radio graph for recurrent caries in the molar.

  4. Gingival Health [ Time Frame: 9 months ]
    the gingival health around the crown is evaluated using Gingival Index (GI) by a periodontal probe and clinical sign of inflammation .

  5. longevity [ Time Frame: 9 months ]
    longevity of the crown is measured by the presence of the crown in the oral cavity cemented and sound.



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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patient with molar incisor hypomineralization having at least one permanent fist molar affected and indicated for full coverage.
  2. Patient is healthy and medically free.
  3. Patient's age range from 6 to 12 years old.
  4. The molar is free from any symptoms of pulp inflammation or has reversible pulpitis (Hypersensitivity).

Exclusion Criteria:

  1. Patient who has any chronic systemic disease or immunocompromised.
  2. Patient with special health care needs.
  3. Molar which has irreversible pulpitis or pulp necrosis.
  4. Molar which has periapical radiolucency and/or abscess or fistula or any periapical pathosis.

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): NCT04209920


Contacts
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Contact: Hagar M Mohie 00201005093609 hmohie@msa.eun.eg
Contact: Mohamed Z Radwan, lecturer 00201111480002 Mradwan@dent.asu.edu.eg

Locations
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Egypt
Ain Shams University Recruiting
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
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Responsible Party: Hagar Mahmoud Mohie, Teaching Assistant at MSA university, Ain Shams University
ClinicalTrials.gov Identifier: NCT04209920    
Other Study ID Numbers: PED 18- 1M
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hagar Mahmoud Mohie, Ain Shams University:
Molar Incisor Hypomineralization
MIH
Hypomineralized
First permanent molar
Molar defects
PMMA
cast adhesive coping
Additional relevant MeSH terms:
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Dental Enamel Hypoplasia
Tooth Abnormalities
Stomatognathic System Abnormalities
Stomatognathic Diseases
Tooth Diseases
Congenital Abnormalities
Chromium
Nickel
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs