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

April 9, 2022 updated by: Marwa Salem, Cairo University
The aim of this study is to evaluate the clinical performance of lithium disilicate crowns restoring endodontically treated teeth with two occlusal preparation schemes.

Study Overview

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

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measuring number of Fracture
Time Frame: one year
using USPHS criteria for clinical evaluation
one year

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
Degree of Marginal discoloration
Time Frame: one year
using USPHS criteria for clinical evaluation
one year
Presence of Caries
Time Frame: one year
using USPHS criteria for clinical evaluation
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2019

Primary Completion (Actual)

July 10, 2021

Study Completion (Actual)

October 10, 2021

Study Registration Dates

First Submitted

August 7, 2019

First Submitted That Met QC Criteria

August 12, 2019

First Posted (Actual)

August 13, 2019

Study Record Updates

Last Update Posted (Actual)

April 15, 2022

Last Update Submitted That Met QC Criteria

April 9, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Fracture of Lithium Disilicate (e.Max) Crowns

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