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Completed

NCT Number: NCT05529329

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

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.

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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

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Azhar University

Cairo, Naser City, 11884, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

overlay

Procedure

Lithium Disilicate partial coverage of hypo-mineralized defected enamel

Other names: Zirconia partial coverage of hypo-mineralized defected enamel

Primary outcomes

  1. Clinical Outcome

    Time frame: 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

  2. Restoration Evaluation

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 7, 2022
Registry last updated
Feb 3, 2023

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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