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

Primary Purpose

Molar Incisor Hypomineralization

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
CAD-CAM milled PMMA crown
Cast metal coping using nickel chromium alloy
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Molar Incisor Hypomineralization focused on measuring Molar Incisor Hypomineralization, MIH, Hypomineralized, First permanent molar, Molar defects, PMMA, cast adhesive coping

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PMMA crown Group

Cast metal coping Group

Arm Description

Hypomineralized first permanent molars in patients with molar incisor hypomineralization.

Hypomineralized first permanent molars in patients with molar incisor hypomineralization.

Outcomes

Primary Outcome Measures

Marginal Integrity
the crowns is evaluated radiographically using a bite wing radio graph for marginal extension integrity.
Related quality of life: questionnaire
A questionnaire about related quality of life of the patient to evaluate patient's satisfaction and comfort.
Recurrent caries
the tooth is evaluated radiographically using a bite wing radio graph for recurrent caries in the molar.
Gingival Health
the gingival health around the crown is evaluated using Gingival Index (GI) by a periodontal probe and clinical sign of inflammation .
longevity
longevity of the crown is measured by the presence of the crown in the oral cavity cemented and sound.

Secondary Outcome Measures

Full Information

First Posted
September 8, 2019
Last Updated
September 6, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04209920
Brief Title
A Comparison of Two Different Management Techniques for Extensive Molar Defects in Patients Suffering From MIH
Official Title
"A Comparison of Two Different Management Techniques for Extensive Molar Defects in Patients Suffering From Molar Incisor Hypomineralization (MIH)" (Randomized Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
April 1, 2021 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
STUDY POPULATION Sixty (60) hypomineralized molars in patients suffering from molar incisor hypomineralization (MIH) will be randomly selected to share in this study from the out-patient clinic of pedodontics department, Faculty of dentistry, Ain Shams University. Patient's approval : All patients and parents will be informed in details about the nature of the investigation and the purpose of the study. They will agree to take part in the study and the parent will sign an informed consent form and the child will have an assent form. All reasonable steps to protect the security of the personal information and privacy of the patient protected health information will be taken. All patients will be notice about their privacy practices, their legal duties and their rights. All patients will be informed about their benefits from research that will be obtaining a restoration to restore and protect the hypomineralized first permanent molars. Patient's history: Precise medical, dental and family histories will be taken from all patients through a direct interview and diagnostic sheet. Parent will be asked about all the possible causes that might cause the molar incisor hypomineralizaion since pregnancy and during the first three years of his life (prenatal, perinatal and postnatal). Patient's Examination: Extra-oral examination: it will be performed following routine procedures to detect any facial abnormality, temporomandibular joint abnormality, any sign of inflammation, pathology or any soft or hard tissue abnormalities. Intra oral examination: it will be performed following routine procedures to examine the sound and affected teeth, soft tissue swelling or fistulae, the occlusion and occlusal relation and proximal contacts, the periodontal status and any other anomalies. Radiographic Evaluation: Panoramic and peri-apical radiograph for the molar which is indicated to be included on the trial will be taken to the patients preoperatively to evaluate the pulp status, the supporting bone and to ensure that the patients are free from any pathological lesions and to evaluate the position and development of the second permanent molars. Patient's Grouping: Selected patients will be randomly divided into two groups: Group (I): patients will receive CAD-CAM milled PMMA crown. Group (II): patients will receive cast metal coping using nickel chromium alloy. STUDY PROCEDURE Clinical steps: Half of the molars will receive CAD-CAM milled PMMA crown and the other half will receive cast adhesive metal coping using nickel chromium alloy randomly. After proper intraoral and radiographic examination impression of upper and lower arches was made for fabrication of temporary crowns to protect the teeth till fabrication of crowns are finished and the crowns are delivered to the patient. Behavior management of the patient, preparation and administration of local anesthesia is done. Preparation For PMMA crowns Removal of any caries associated to the molar and then reduction of the molar (1mm) all round the molar and (1.5mm) occlusally and impression is taken for upper and lower jaws after reduction for crown fabrication. For Cast Adhesive Coping (CAC) Removal of any caries associated to the molar and then reduction of the molar (0.5: 0.7 mm) all round the molar and (1: 1.5mm) occlusally and impression is taken for upper and lower jaws after reduction for crown fabrication. Temporary crown are fabricated and cemented using zinc oxide and eugenol. Delivery and Cementation For PMMA crown After crown is fabricated, the tooth is cleaned, dried and isolated and cementation is done using Self Etch Resin Cement. For Cast Adhesive Coping (CAC) After crown is fabricated, the tooth is cleaned and dried and then etched for 30 seconds and then washed and dried to give chalky white appearance, and then the crown is cemented using dual composite cement. Evaluation of quality of both crowns is checked by patient's satisfaction, comfort and function, proper occlusion and proximal contact, margins of the crowns and coverage of all surfaces adequately. The patient will be instructed to maintain good oral hygiene and to avoid eating sticky food. Then the patient will have 1, 3, 6 and 9 months follow up to evaluate the crowns by clinical examination to evaluate margins and clinical performance of the crowns and gingival hygiene, and bitewing radio graph to evaluate margins of the crowns and any recurrent caries, and questionnaire about related quality of life of the patient to evaluate patient's satisfaction and comfort then data is collected and recorded. The study is expected to be done in 12 months. STATISTICAL ANALYSIS A proper statistical method will be carried out to compare between CAD-CAM milled PolyMethyl Methacrylate (PMMA) and Cast adhesive metal coping (CAC) for management of extensive first permanent molar defects in patients suffering from MIH.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Molar Incisor Hypomineralization
Keywords
Molar Incisor Hypomineralization, MIH, Hypomineralized, First permanent molar, Molar defects, PMMA, cast adhesive coping

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PMMA crown Group
Arm Type
Active Comparator
Arm Description
Hypomineralized first permanent molars in patients with molar incisor hypomineralization.
Arm Title
Cast metal coping Group
Arm Type
Active Comparator
Arm Description
Hypomineralized first permanent molars in patients with molar incisor hypomineralization.
Intervention Type
Device
Intervention Name(s)
CAD-CAM milled PMMA crown
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Cast metal coping using nickel chromium alloy
Intervention Description
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 Measure Information:
Title
Marginal Integrity
Description
the crowns is evaluated radiographically using a bite wing radio graph for marginal extension integrity.
Time Frame
9 months follow up
Title
Related quality of life: questionnaire
Description
A questionnaire about related quality of life of the patient to evaluate patient's satisfaction and comfort.
Time Frame
9 months
Title
Recurrent caries
Description
the tooth is evaluated radiographically using a bite wing radio graph for recurrent caries in the molar.
Time Frame
9 months
Title
Gingival Health
Description
the gingival health around the crown is evaluated using Gingival Index (GI) by a periodontal probe and clinical sign of inflammation .
Time Frame
9 months
Title
longevity
Description
longevity of the crown is measured by the presence of the crown in the oral cavity cemented and sound.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient with molar incisor hypomineralization having at least one permanent fist molar affected and indicated for full coverage. Patient is healthy and medically free. Patient's age range from 6 to 12 years old. The molar is free from any symptoms of pulp inflammation or has reversible pulpitis (Hypersensitivity). Exclusion Criteria: Patient who has any chronic systemic disease or immunocompromised. Patient with special health care needs. Molar which has irreversible pulpitis or pulp necrosis. Molar which has periapical radiolucency and/or abscess or fistula or any periapical pathosis.
Facility Information:
Facility Name
Ain Shams University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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