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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04054674
Other study ID # CEBC-CU-2019920
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 10, 2019
Est. completion date October 10, 2021

Study information

Verified date April 2022
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date October 10, 2021
Est. primary completion date July 10, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Abutments with flat occlusal scheme preparation restored by lithium disilicate crowns
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.

Locations

Country Name City State
Egypt Cairo university Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measuring number of Fracture using USPHS criteria for clinical evaluation one year
Secondary Degree of Marginal adaptation using USPHS criteria for clinical evaluation one year
Secondary Degree of Marginal discoloration using USPHS criteria for clinical evaluation one year
Secondary Presence of Caries using USPHS criteria for clinical evaluation one year