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

Molar Incisor Hypomineralization Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05434884
• Other study ID #: AlAzharUniversity
• Status: Completed
• Phase: N/A
• Start date: July 10, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: June 2022
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 1, 2022
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Enamel Hypoplasia
• Molar Incisor Hypomineralization

Intervention

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
• endocrown restorations
endocrown restorations

Locations

Country	Name	City	State
Egypt	Dr.sara nabil	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Al-Azhar University	Altura

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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