Survival of Endocrowns Made From Different Ceramics

November 3, 2021 updated by: Ahmad El-Ma'aita, University of Jordan

The Endocrown; a Prospective Randomised Clinical Trial of Three Different Ceramics

Restoration of endodontically treated teeth requires a means to protect the cusps from the wedging forces of occlusion. When there is extensive loss of tooth structure, cuspal coverage is warranted. Usually this is in the form of indirect restoration. Traditionally, full coverage crowns have been used which would require further removal of sound tooth structure. Recently, adhesive alternatives have been introduced which allow for conservation of tooth structure.

Different materials can be used for this purpose. The evidence on the long-term survival of these materials is scarce. This study aims to investigate the short and medium-long term survival rate of these prostheses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

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

  • Jordan
      • Amman, Jordan, 11831
        • Jordan University Hospital

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Root canal treated molars with significant loss of tooth structure
  • Supra-gingival margins
  • Teeth scheduled for cuspal-covering indirect restorations

Exclusion Criteria:

  • Teeth with extensive cracks or fractures
  • Teeth with deep subgingival margins
  • Non-functional teeth (no opposing dentition)
  • Teeth with advanced periodontitis

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Lithium disilicate
Lithium disilicate: a type of ceramic material used to make a dental prosthesis that replaces missing tooth structure following root canal treatment. Other names might include: E-max crowns, computer-aided design and computer-aided manufacturing (CAD CAM) crowns
Device: Dental prosthesis
Replacement of missing tooth structure using Lithium disilicate porcelain
Other Names:
  • Crowns
ACTIVE_COMPARATOR: Monolithic zirconia
Monolithic zirconia: a type of ceramic material used to make a dental prosthesis that replaces the missing tooth structure following root canal treatment. Other names might include: Zolid crown, Bruxzir, Bretau, CAD CAM crowns
Device: Dental crown
Replacement og missing tooth structure using monolithic zirconia
Other Names:
  • Endocrown
ACTIVE_COMPARATOR: Hybrid ceramic
Hybrid ceramic: a type of ceramic material used to make a dental prosthesis that replaces the missing tooth structure following root canal treatment. Other names might include: Enamec, Lava Ultimate, CAD CAM crowns
Device: Hybrid ceramic
Restroration of endodontically treated teeth using hybrid ceramic
Other Names:
  • Indirect restoration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival of Dental Prosthesis
Time Frame: 24 months
The endocrowns (the dental prosthesis studied) were assessed after 24 months. Those that were functional and without any symptoms were considered surviving.
24 months

Collaborators and Investigators

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

Sponsor

University of Jordan

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)

July 1, 2018

Primary Completion (ACTUAL)

December 31, 2020

Study Completion (ACTUAL)

December 31, 2020

Study Registration Dates

First Submitted

April 1, 2018

First Submitted That Met QC Criteria

May 29, 2018

First Posted (ACTUAL)

May 31, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 4, 2021

Last Update Submitted That Met QC Criteria

November 3, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10/2017/25289

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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