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

NCT05434884 | Completed

• 1 other identifier: AlAzharUniversity
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Conditions

Molar Incisor Hypomineralization

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

OV group

EXPERIMENTAL

Patients will receive occlusal veneer restorations

Procedure: occlusal veneer restorations

EN group

EXPERIMENTAL

Patients will receive endocrown restorations

Procedure: endocrown restorations

Interventions

occlusal veneer restorations 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

OV group

endocrown restorations PROCEDURE

endocrown restorations

EN group

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Patients have active periodontal diseases.
• Patient with poor oral hygiene and motivation.
• Patient with psychiatric problems or unrealistic expectations

Sponsors & Collaborators

• Al-Azhar University: lead
• Altura: collaborator

Study Sites (1)

Dr.sara nabil

Cairo, Egypt

Location

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Mona Hossam, professor

  doctor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of pediatric dentistry

Model Details: Randomized controlled trial (RCT)

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: June 28, 2022
• Study Start: July 10, 2020
• Primary Completion: December 10, 2021
• Study Completion: March 1, 2022
• Last Updated: June 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)