Wear Behavior of Milled Posterior Crowns Fabricated From the New Monolithic Zirconia 5Y-TZP/3Y-TZP Compared to Lithium Disilicate
1 other identifier
interventional
24
1 country
1
Brief Summary
In-vitro studies do not represent the actual masticatory environment and cannot simulate the intricate chewing pattern. Hence, there is a need for an in vivo study evaluating the wear potential of the newly introduced strength - color gradient multilayered zirconia IPS e.max ZirCAD Prime (5Y-TZP/3Y-TZP) and compare it to Lithium Disilicate IPS e.max CAD which has proven to have favorable wear patterns.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2021
CompletedFirst Posted
Study publicly available on registry
March 18, 2021
CompletedStudy Start
First participant enrolled
August 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedJune 10, 2021
June 1, 2021
7 months
February 17, 2021
June 9, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
The amount of occlusal wear in natural antagonist enamel caused by the restorative material
The amount of occlusal wear in natural antagonist enamel, using digital superimposition of model scans after 1 year, measured in micrometer.
1 year
Secondary Outcomes (1)
The amount of occlusal wear in the restorative material itself
1 year
Study Arms (2)
Lithium Disilicate IPS e.max crowns in posterior teeth
ACTIVE COMPARATORMonolithic Zirconia (5Y-TZP/3-YTZP) crowns in posterior teeth
EXPERIMENTALInterventions
wear of the new material of monolithic zirconia (5Y-TZP/3-YTZ) ZirCAD Prime in posterior teeth
wear of lithium disilicate IPS e.max crown in posterior teeth
Eligibility Criteria
You may qualify if:
- All subjects are required to:
- Be aged 21-50 years old, be able to read and sign the informed consent document. 2- Psychologically and physically able to withstand conventional dental procedures.
- Patients with mutilated posterior teeth indicated for full coverage restorations.
- Patients with sound natural antagonists. 5- Able to attend punctually for preplanned visits and evaluation. 6- Have no active periodontal or pulpal diseases.
- There should be no apparent loss or wear in opposing enamel.
You may not qualify if:
- Patient with active resistant periodontal diseases.
- Patients with parafunctional habits and bruxism.
- Patients with poor oral hygiene, high caries risk and uncooperative patients. 3- Pregnant women.
- Patients in the growth stage with partially erupted teeth. 5- Psychiatric problems or unrealistic expectations.
- Lack of opposing dentition in the area of interest. 7- Restored occlusal surface opposing the planned restoration. 8- The presence of a removable or fixed orthodontic appliance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University
Cairo, 11865, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Rana Sherif, professor
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
February 17, 2021
First Posted
March 18, 2021
Study Start
August 1, 2021
Primary Completion
March 1, 2022
Study Completion
June 1, 2022
Last Updated
June 10, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share