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

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

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

Study Overview

• Status: Completed
• Conditions: Molar Incisor Hypomineralization
• Intervention / Treatment: Procedure: occlusal veneer restorations; Procedure: endocrown restorations

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Dr.sara nabil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OV group; Patients will receive occlusal veneer restorations	Procedure: 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
Experimental: EN group; Patients will receive endocrown restorations	Procedure: endocrown restorations; endocrown restorations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
retention	Clinical evaluation of all restorations will be performed according to: - Modified United States Public Health Service (USPHS) Ryge Criteria,at12 month after cementation	1 year
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	6 months
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	12 months
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	3 months

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Collaborators: Altura
• Investigators: Study Director: Mona Hossam, professor, Doctor

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2020
• Primary Completion (Actual): December 10, 2021
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: June 25, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Actual): June 28, 2022
• Last Update Submitted That Met QC Criteria: June 25, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Tooth Abnormalities; Dental Enamel Hypoplasia; Anti-Infective Agents; Dermatologic Agents; Antifungal Agents; Keratolytic Agents; Salicylic Acid
• Other Study ID Numbers: AlAzharUniversity

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: sharing primary results only

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No