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Clinical Trials/NCT05434884
NCT05434884
Completed
Not Applicable

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

Al-Azhar University1 site in 1 country64 target enrollmentJuly 10, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Molar Incisor Hypomineralization
Sponsor
Al-Azhar University
Enrollment
64
Locations
1
Primary Endpoint
marginal integrity
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 10, 2020
End Date
March 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

sara nabil

Lecturer of pediatric dentistry

Al-Azhar University

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

Outcomes

Primary Outcomes

marginal integrity

Time Frame: 6 months

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

retention

Time Frame: 1 year

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

colour stability

Time Frame: 12 months

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

Time Frame: 3 months

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

Study Sites (1)

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