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

Molar Incisor Hypomineralization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05529329
• Other study ID #: REC-PD-21-08
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: August 20, 2022

Study information

• Verified date: February 2023
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 20, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Enamel Hypoplasia
• Molar Incisor Hypomineralization

Intervention

Procedure:
• overlay
Lithium Disilicate partial coverage of hypo-mineralized defected enamel

Locations

Country	Name	City	State
Egypt	Al-Azhar University	Cairo	Naser City

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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