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Clinical Trials/NCT05529329
NCT05529329CompletedNot Applicable

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

Al-Azhar University2 sites in 1 country52 target enrollmentStarted: April 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
52
Locations
2
Primary Endpoint
Restoration Evaluation

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
7 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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).

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

AMMohammed

lecturer of Pediatric dentistry

Al-Azhar University

Study Sites (2)

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