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Clinical Performance Of Lithium Disilicate Crowns Restoring Endodontically Treated Teeth With Two Occlusal Preparation Schemes

Primary Purpose

Fracture of Lithium Disilicate (e.Max) Crowns

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Abutments with flat occlusal scheme preparation restored by lithium disilicate crowns
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fracture of Lithium Disilicate (e.Max) Crowns focused on measuring e.max, occlusal scheme, endodontically treated teeth

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Cairo university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

flat occlusal scheme restored by lithium disilicate crown

planar occlusal scheme restored by lithium disilcate crown

Arm Description

flat occlusal preparation of endodontically treated teeth is performed clinically and then the final restorations will be lithium disilicate (e.max) crowns.

planar occlusal preparation of endodontically treated teeth is performed clinically and then the final restorations will be lithium disilicate (e.max) crowns.

Outcomes

Primary Outcome Measures

Measuring number of Fracture
using USPHS criteria for clinical evaluation

Secondary Outcome Measures

Degree of Marginal adaptation
using USPHS criteria for clinical evaluation
Degree of Marginal discoloration
using USPHS criteria for clinical evaluation
Presence of Caries
using USPHS criteria for clinical evaluation

Full Information

First Posted
August 7, 2019
Last Updated
April 9, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04054674
Brief Title
Clinical Performance Of Lithium Disilicate Crowns Restoring Endodontically Treated Teeth With Two Occlusal Preparation Schemes
Official Title
Clinical Performance Of Lithium Disilicate Crowns Restoring Endodontically Treated Teeth With Two Occlusal Preparation Schemes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
July 10, 2021 (Actual)
Study Completion Date
October 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of this study is to evaluate the clinical performance of lithium disilicate crowns restoring endodontically treated teeth with two occlusal preparation schemes.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture of Lithium Disilicate (e.Max) Crowns
Keywords
e.max, occlusal scheme, endodontically treated teeth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
flat occlusal scheme restored by lithium disilicate crown
Arm Type
Experimental
Arm Description
flat occlusal preparation of endodontically treated teeth is performed clinically and then the final restorations will be lithium disilicate (e.max) crowns.
Arm Title
planar occlusal scheme restored by lithium disilcate crown
Arm Type
No Intervention
Arm Description
planar occlusal preparation of endodontically treated teeth is performed clinically and then the final restorations will be lithium disilicate (e.max) crowns.
Intervention Type
Procedure
Intervention Name(s)
Abutments with flat occlusal scheme preparation restored by lithium disilicate crowns
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measuring number of Fracture
Description
using USPHS criteria for clinical evaluation
Time Frame
one year
Secondary Outcome Measure Information:
Title
Degree of Marginal adaptation
Description
using USPHS criteria for clinical evaluation
Time Frame
one year
Title
Degree of Marginal discoloration
Description
using USPHS criteria for clinical evaluation
Time Frame
one year
Title
Presence of Caries
Description
using USPHS criteria for clinical evaluation
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Cairo university
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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Clinical Performance Of Lithium Disilicate Crowns Restoring Endodontically Treated Teeth With Two Occlusal Preparation Schemes

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