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

Not Applicable

Completed

• Conditions: Molar Incisor Hypomineralization
• Interventions: Procedure: overlay

• Registration Number: NCT05529329
• Lead Sponsor: Al-Azhar University

Brief Summary

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.

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 Timeline

• Study Start: 2021-04-01
• Primary Completion: 2022-04-01
• Study Completion: 2022-08-20
• Study First Submitted: 2022-09-02
• Study First Submitted QC: 2022-09-06
• Study First Posted: 2022-09-07
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-01
• Last Update Posted: 2023-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group (Z)	overlay	patients received zirconia restorations group
Group (EC)	overlay	patients received IPS E.max Cad restorations group

Primary Outcome Measures

Name	Time	Method
Restoration Evaluation	one year	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).
Clinical Outcome	one year	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

Trial Locations

Locations (1)

Al-Azhar University; 🇪🇬 Cairo, Naser City, Egypt