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Clinical Performance of Two Cad-cam Fabricated Ceramic Restoration in Teeth Affected With MIH

Primary Purpose

Molar Incisor Hypomineralization

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

occlusal veneer restorations

endocrown restorations

About this trial

This is an interventional treatment trial for Molar Incisor Hypomineralization

Eligibility Criteria

8 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:-

Patient from 8 to 13 years
permanent first molar tooth affected with different severity levels of MIH
Ability to physically and psychologically tolerate conventional restorative procedures.

Exclusion Criteria:.

Patients have active periodontal diseases.
Patient with poor oral hygiene and motivation.
Patient with psychiatric problems or unrealistic expectations

Sites / Locations

Dr.sara nabil

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

OV group

EN group

Arm Description

Patients will receive occlusal veneer restorations

Patients will receive endocrown restorations

Outcomes

Primary Outcome Measures

retention

Clinical evaluation of all restorations will be performed according to: - Modified United States Public Health Service (USPHS) Ryge Criteria,at12 month after cementation

marginal integrity

Clinical evaluation of all restorations will be performed according to: - Modified United States Public Health Service (USPHS) Ryge Criteria, at 6 months after cementation

colour stability

Clinical evaluation of all restorations will be performed according to: - Modified United States Public Health Service (USPHS) Ryge Criteria, at 12 months after cementation

Elimination of sensitivity

Clinical evaluation of all restorations will be performed according to: - Modified United States Public Health Service (USPHS) Ryge Criteria, at 3, months after cementation

Secondary Outcome Measures

Full Information

NCT ID

NCT05434884

First Posted

February 10, 2022

Last Updated

June 25, 2022

Sponsor

Al-Azhar University

Collaborators

Altura

1. Study Identification

Unique Protocol Identification Number

NCT05434884

Brief Title

Clinical Performance of Two Cad-cam Fabricated Ceramic Restoration in Teeth Affected With MIH

Official Title

Clinical Performance of Two CAD/CAM Fabricated Ceramic Restorations With Different Preparation Designs for Rehabilitation Of Permanent First Molars Affected With Molar Incisor Hypomineralisation (MIH): Clinical Randomized Trial

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

July 10, 2020 (Actual)

Primary Completion Date

December 10, 2021 (Actual)

Study Completion Date

March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Al-Azhar University

Collaborators

Altura

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study will be performed to evaluate the clinical performance (Plaque accumulation, fracture of (restoration or tooth), postoperative sensitivity, secondary caries, marginal fit and discoloration) of two CAD/CAM fabricated ceramic restorations (zirconia-reinforced lithium silicate glass ceramic and hybrid ceramic) with different preparation designs (modified occlusal veneer and endocrown) for rehabilitation of permanent first molars affected with different severity level of molar incisor hypomineralisation (MIH), evaluated at different time periods

Detailed Description

Clinical evaluation of all restorations will be performed according to: - Modified United States Public Health Service (USPHS) Ryge Criteria, at base line (1 week), 3, 6 and 12 months after cementation.

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

Randomized controlled trial (RCT)

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OV group

Arm Type

Experimental

Arm Description

Patients will receive occlusal veneer restorations

Arm Title

EN group

Arm Type

Experimental

Arm Description

Patients will receive endocrown restorations

Intervention Type

Procedure

Intervention Name(s)

occlusal veneer restorations

Intervention Description

occlusal veneer preparation with circumferential chamfer finish line and proximal slot " proposed modified occlusal veneer design" for rehabilitation of moderate level of permanent first molars. OrPatients will receive endocrown restorations for rehabilitation of sever level of permanent first molars

Intervention Type

Procedure

Intervention Name(s)

endocrown restorations

Intervention Description

endocrown restorations

Primary Outcome Measure Information:

Title

retention

Description

Clinical evaluation of all restorations will be performed according to: - Modified United States Public Health Service (USPHS) Ryge Criteria,at12 month after cementation

Time Frame

1 year

Title

marginal integrity

Description

Clinical evaluation of all restorations will be performed according to: - Modified United States Public Health Service (USPHS) Ryge Criteria, at 6 months after cementation

Time Frame

6 months

Title

colour stability

Description

Clinical evaluation of all restorations will be performed according to: - Modified United States Public Health Service (USPHS) Ryge Criteria, at 12 months after cementation

Time Frame

12 months

Title

Elimination of sensitivity

Description

Clinical evaluation of all restorations will be performed according to: - Modified United States Public Health Service (USPHS) Ryge Criteria, at 3, months after cementation

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

13 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria:- Patient from 8 to 13 years permanent first molar tooth affected with different severity levels of MIH Ability to physically and psychologically tolerate conventional restorative procedures. Exclusion Criteria:. Patients have active periodontal diseases. Patient with poor oral hygiene and motivation. Patient with psychiatric problems or unrealistic expectations

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mona Hossam, professor

Organizational Affiliation

doctor

Official's Role

Study Director

Facility Information:

Facility Name

Dr.sara nabil

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

sharing primary results only

Learn more about this trial

Clinical Performance of Two Cad-cam Fabricated Ceramic Restoration in Teeth Affected With MIH

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