- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04054674
Clinical Performance Of Lithium Disilicate Crowns Restoring Endodontically Treated Teeth With Two Occlusal Preparation Schemes
Study Overview
Status
Intervention / Treatment
Detailed Description
Statement of the problem:
The endodontically treated teeth need to be restored back to form, function and aesthetics. The quality of the coronal restoration will directly impact on their survival and success. The aim of the coronal restoration of endodontically treated teeth is to provide the necessary strength for the restoration/tooth complex through tooth preparation in order to withstand functional stress and prevent crown and/or root fracture. The use of ceramic crowns has increased substantially in recent years because of their superior esthetics and high mechanical properties. Long term success of all ceramic crowns is affected by many factors and the failure patterns of these all ceramic crowns should be inspected closely to detect their clinical performance.
Rationale for carrying out the trial:
Endodontic treatment weakens posterior teeth and ought to be covered by crowns.The capability of these crowns to bear load relies on the preparation of an appropriate design and the selection of a crown material with adequate fracture strength and thickness. In vital teeth, the anatomic occlusal preparation design is followed such that the occlusal surface is reduced uniformly, maintaining the cusps and normal inclined planes but at a reduced height. This aids in minimizing the risk of pulp injury. In contrast, in non-vital teeth, this design can be modified such that the occlusal surface is prepared in two planes (buccal and lingual planes). A flat prepared occlusal surface provides less quantitative and better qualitative stresses when compared to an anatomically prepared surface
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo, Egypt
- Cairo University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Have no active periodontal diseases or periapical pathosis
- No tooth mobility or furcation involvement with sufficient occluso-gingival height
- Psychologically and physically able to withstand conventional dental procedures
- Patients with good endodontically treated teeth indicated for full coverage restorations
- Able to return for follow-up examination and evaluation
Exclusion Criteria:
- Patient with active resistant periodontal diseases
- Patients with poor oral hygiene and uncooperative
- Pregnant women that won't be able to come for follow-up visits
- Patients in the growth stage with partially erupted teeth
- Psychiatric problems or unrealistic expectations
- Lack of opposing dentition in the area of interest
- Patients with poor root canal treatment
- Patients with parafunctional habits (eg. Bruxism)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: flat occlusal scheme restored by lithium disilicate crown
flat occlusal preparation of endodontically treated teeth is performed clinically and then the final restorations will be lithium disilicate (e.max) crowns.
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Clinical trials lacks information about flat occlusal preparation design in case of endodontically treated teeth.
Therefore, this is tested during preparation when compared to planer occlusal preparation while the final restoration in both arms is lithium disilicate (e.max) crowns.
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No Intervention: planar occlusal scheme restored by lithium disilcate crown
planar occlusal preparation of endodontically treated teeth is performed clinically and then the final restorations will be lithium disilicate (e.max) crowns.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measuring number of Fracture
Time Frame: one year
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using USPHS criteria for clinical evaluation
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one year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Degree of Marginal adaptation
Time Frame: one year
|
using USPHS criteria for clinical evaluation
|
one year
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Degree of Marginal discoloration
Time Frame: one year
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using USPHS criteria for clinical evaluation
|
one year
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Presence of Caries
Time Frame: one year
|
using USPHS criteria for clinical evaluation
|
one year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEBC-CU-2019920
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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