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

NCT05529329 | Completed

• 1 other identifier: REC-PD-21-08
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Molar Incisor Hypomineralization

Keywords

MIH - zironia - Lithium Disilicate - Overlays

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Group (Z)

ACTIVE COMPARATOR

patients received zirconia restorations group

Procedure: overlay

Group (EC)

EXPERIMENTAL

patients received IPS E.max Cad restorations group

Procedure: overlay

Interventions

overlay PROCEDURE

Lithium Disilicate partial coverage of hypo-mineralized defected enamel

Also known as: Zirconia partial coverage of hypo-mineralized defected enamel

Group (EC); Group (Z)

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar University

Cairo, Naser City, 11884, Egypt

Location

MeSH Terms

Conditions

Molar Hypomineralization

Interventions

Denture, Overlay

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dentures; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies

Study Officials

• alaa F mohammed, Ph. D

  Al-Azhar University- faculty of dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of Pediatric dentistry

Model Details: Randomized Clinical Trial

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 7, 2022
• Study Start: April 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: August 20, 2022
• Last Updated: February 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: one year
• Access Criteria: alaaaldehna.26@azhar.edu.eg

Locations

EG (1)