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

NCT ID: NCT05434884

Last Updated: 2022-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-10

Study Completion Date

2022-03-01

Brief Summary

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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

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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.

Conditions

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Molar Incisor Hypomineralization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial (RCT)
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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OV group

Patients will receive occlusal veneer restorations

Group Type EXPERIMENTAL

occlusal veneer restorations

Intervention Type PROCEDURE

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

EN group

Patients will receive endocrown restorations

Group Type EXPERIMENTAL

endocrown restorations

Intervention Type PROCEDURE

endocrown restorations

Interventions

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occlusal veneer restorations

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

endocrown restorations

endocrown restorations

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Altura

INDUSTRY

Sponsor Role collaborator

Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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sara nabil

Lecturer of pediatric dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mona Hossam, professor

Role: STUDY_DIRECTOR

doctor

Locations

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Dr.sara nabil

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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AlAzharUniversity

Identifier Type: -

Identifier Source: org_study_id

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