Back to resultsZirconia Versus Lithium Di-silicate Overlays for Restoring Hypomineralized Molars Affected With MIH
Primary Purpose
Molar Incisor Hypomineralization
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
overlay
Sponsored by
About this trial
This is an interventional treatment trial for Molar Incisor Hypomineralization focused on measuring MIH - zironia - Lithium Disilicate - Overlays
Eligibility Criteria
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.
Sites / Locations
- Al-Azhar University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group (Z)
Group (EC)
Arm Description
patients received zirconia restorations group
patients received IPS E.max Cad restorations group
Outcomes
Primary Outcome Measures
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
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT05529329
First Posted
September 2, 2022
Last Updated
February 1, 2023
Sponsor
Al-Azhar University
1. Study Identification
Unique Protocol Identification Number
NCT05529329
Brief Title
Zirconia Versus Lithium Di-silicate Overlays for Restoring Hypomineralized Molars Affected With MIH
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
August 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Molar Incisor Hypomineralization
Keywords
MIH - zironia - Lithium Disilicate - Overlays
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Clinical Trial
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group (Z)
Arm Type
Active Comparator
Arm Description
patients received zirconia restorations group
Arm Title
Group (EC)
Arm Type
Experimental
Arm Description
patients received IPS E.max Cad restorations group
Intervention Type
Procedure
Intervention Name(s)
overlay
Other Intervention Name(s)
Zirconia partial coverage of hypo-mineralized defected enamel
Intervention Description
Lithium Disilicate partial coverage of hypo-mineralized defected enamel
Primary Outcome Measure Information:
Title
Clinical Outcome
Description
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
Time Frame
one year
Title
Restoration Evaluation
Description
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).
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
alaa F mohammed, Ph. D
Organizational Affiliation
Al-Azhar University- faculty of dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al-Azhar University
City
Cairo
State/Province
Naser City
ZIP/Postal Code
11884
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing Time Frame
one year
IPD Sharing Access Criteria
alaaaldehna.26@azhar.edu.eg
Learn more about this trial
Zirconia Versus Lithium Di-silicate Overlays for Restoring Hypomineralized Molars Affected With MIH
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