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

Not Applicable

Completed

• Conditions: Molar Incisor Hypomineralization
• Interventions: Procedure: occlusal veneer restorations; Procedure: endocrown restorations

• Registration Number: NCT05434884
• Lead Sponsor: Al-Azhar University

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.

Study Timeline

• Study Start: 2020-07-10
• Primary Completion: 2021-12-10
• Study First Submitted: 2022-02-10
• Study Completion: 2022-03-01
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-25
• Last Update Submitted: 2022-06-25
• Study First Posted: 2022-06-28
• Last Update Posted: 2022-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OV group	occlusal veneer restorations	Patients will receive occlusal veneer restorations
EN group	endocrown restorations	Patients will receive endocrown restorations

Primary Outcome Measures

Name	Time	Method
marginal integrity	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	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	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	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

Trial Locations

Locations (1)

Dr.sara nabil; 🇪🇬 Cairo, Egypt