Zirconia Versus Lithium Di-silicate Overlays for Restoring Hypomineralized Molars Affected With MIH

Clinical Outcome of Zirconia Versus Lithium Di-silicate Overlays Restorations for Restoring Vital Young Permanent First Molar Teeth Affected With Moderate Form of Molar Incisor Hypomineralization: Randomized Clinical Trial

the study evaluate the clinical outcome of zirconia versus lithium disilicate overlays restorations for restoring vital young permanent first molar teeth affected with moderate form of molar Incisor hypomineralization: randomized clinical trial.

Study Overview

• Status: Completed
• Conditions: Molar Incisor Hypomineralization
• Intervention / Treatment: Procedure: overlay

Detailed Description

To compare the one-year clinical outcome of zirconia versus lithium disilicate overlays restorations. Materials and methods: Twenty patients were distributed into two groups in relation to the material used for the fabrication of overlays restorations; group (Z) (n=10): patients received zirconia restorations, group (EC): patients received IPS E.max Cad restorations. Clinical and radiographic evaluations of these restorations were carried out at base line (1 week), 3, 6 and 12 months after cementation using FDI World Dental Federation criteria

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Naser City
    • Cairo, Naser City, Egypt, 11884
      • Al-Azhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children's age ranging from 10 to 15 years old.
• Existence of large carious lesion in young permanent first molar teeth associated with weak cusps.
• Signs of vital pulp without symptoms of pulpitis.
• Presence of antagonists and adjacent teeth and occlusal contacts with good level of oral hygiene.
• Children should be able to physically and psychologically tolerate conventional restorative procedures.

Exclusion Criteria:

• Children with poor oral hygiene and symptoms of pulpitis.
• Children suffer from parafunctional habits.
• Children with any debilitating systemic disorder.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group (Z); patients received zirconia restorations group	Procedure: overlay; Lithium Disilicate partial coverage of hypo-mineralized defected enamel; Other Names: Zirconia partial coverage of hypo-mineralized defected enamel
Experimental: Group (EC); patients received IPS E.max Cad restorations group	Procedure: overlay; Lithium Disilicate partial coverage of hypo-mineralized defected enamel; Other Names: Zirconia partial coverage of hypo-mineralized defected enamel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Outcome	compare the one-year clinical outcome of zirconia versus lithium disilicate overlays restoration of vital young permanent first molar teeth affected with moderate form of Molar Incisor Hypomineralization	one year
Restoration Evaluation	Restorations were assessed clinically using dental explorer, mirror and radiographically according to FDI World Dental Federation criteria over one-year period at (base line "1 week", 3, 6 and 12 months) afterward cementation. There were three assessment categories (esthetics, function, biological) each with five subcategories. From best to worst, the subcategories were: (1) clinically excellent, (2) clinically good, (3) clinically sufficient, (4) clinically not sufficient but repairable and (5) clinically unacceptable. Assessment with category (5) was rated as a clinical failure. Statistical analysis for baseline and follow-up criteria was performed with Wilcoxon-Test (p<0.05) (SPSS; IBM,Chicago, IL).	one year

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Principal Investigator: alaa F mohammed, Ph. D, Al-Azhar University- faculty of dentistry

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): August 20, 2022

Study Registration Dates

• First Submitted: September 2, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): February 3, 2023
• Last Update Submitted That Met QC Criteria: February 1, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: MIH - zironia - Lithium Disilicate - Overlays
• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Tooth Abnormalities; Dental Enamel Hypoplasia
• Other Study ID Numbers: REC-PD-21-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Twenty patients were distributed into two groups in relation to the material used for the fabrication of overlays restorations; group (Z) (n=10): patients received zirconia restorations, group (EC): patients received IPS E.max Cad restorations. Clinical and radiographic evaluations of these restorations were carried out at base line (1 week), 3, 6 and 12 months after cementation using FDI World Dental Federation criteria
• IPD Sharing Time Frame: one year
• IPD Sharing Access Criteria: alaaaldehna.26@azhar.edu.eg
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

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