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Completed

NCT Number: NCT05434884

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

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

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Key information

Conditions

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

Age range

8 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr.sara nabil

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

endocrown restorations

Procedure

endocrown restorations

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Collaborators

  • Altura

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jun 28, 2022
Registry last updated
Jun 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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