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Survival of Endocrowns Made From Different Ceramics

Primary Purpose

Pulp Disease, Dental, Dental Caries, Dental Leakage

Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Dental prosthesis
Dental crown
Hybrid ceramic
Sponsored by
University of Jordan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulp Disease, Dental

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Jordan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Lithium disilicate

Monolithic zirconia

Hybrid ceramic

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 1, 2018
Last Updated
November 3, 2021
Sponsor
University of Jordan
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1. Study Identification

Unique Protocol Identification Number
NCT03542019
Brief Title
Survival of Endocrowns Made From Different Ceramics
Official Title
The Endocrown; a Prospective Randomised Clinical Trial of Three Different Ceramics
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulp Disease, Dental, Dental Caries, Dental Leakage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three different ceramic types for restoration of endodontically treated teeth
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
All ceramic materials will be assigned randomly by research assistant who has randomised tables generated by a statistician
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lithium disilicate
Arm Type
Active Comparator
Arm Description
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
Arm Title
Monolithic zirconia
Arm Type
Active Comparator
Arm Description
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
Arm Title
Hybrid ceramic
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Dental prosthesis
Other Intervention Name(s)
Crowns
Intervention Description
Replacement of missing tooth structure using Lithium disilicate porcelain
Intervention Type
Device
Intervention Name(s)
Dental crown
Other Intervention Name(s)
Endocrown
Intervention Description
Replacement og missing tooth structure using monolithic zirconia
Intervention Type
Device
Intervention Name(s)
Hybrid ceramic
Other Intervention Name(s)
Indirect restoration
Intervention Description
Restroration of endodontically treated teeth using hybrid ceramic
Primary Outcome Measure Information:
Title
Survival of Dental Prosthesis
Description
The endocrowns (the dental prosthesis studied) were assessed after 24 months. Those that were functional and without any symptoms were considered surviving.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Jordan University Hospital
City
Amman
ZIP/Postal Code
11831
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
No

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Survival of Endocrowns Made From Different Ceramics

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