NCT03542019

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 31, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
10 months until next milestone

Results Posted

Study results publicly available

November 4, 2021

Completed
Last Updated

November 4, 2021

Status Verified

October 1, 2021

Enrollment Period

2.5 years

First QC Date

April 1, 2018

Results QC Date

September 8, 2021

Last Update Submit

November 3, 2021

Conditions

Pulp Disease, DentalDental CariesDental Leakage

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 months

Study Arms (3)

Lithium disilicate

ACTIVE COMPARATOR

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

Monolithic zirconia

ACTIVE COMPARATOR

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

Hybrid ceramic

ACTIVE COMPARATOR

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

Interventions

Dental prosthesisDEVICE

Replacement of missing tooth structure using Lithium disilicate porcelain

Also known as: Crowns
Lithium disilicate
Dental crownDEVICE

Replacement og missing tooth structure using monolithic zirconia

Also known as: Endocrown
Monolithic zirconia
Hybrid ceramicDEVICE

Restroration of endodontically treated teeth using hybrid ceramic

Also known as: Indirect restoration
Hybrid ceramic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordan University Hospital

Amman, 11831, Jordan

Location

MeSH Terms

Conditions

Dental Pulp DiseasesDental CariesDental Leakage

Interventions

Dental ProsthesisCrowns

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesTooth Demineralization

Intervention Hierarchy (Ancestors)

ProsthodonticsDentistryProstheses and ImplantsEquipment and Supplies

Results Point of Contact

Title
Dr. Ahmad El-Ma'aita
Organization
University of Jordan
a.maaita@ju.edu.jo
+9626535 5000

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
All ceramic materials will be assigned randomly by research assistant who has randomised tables generated by a statistician
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Three different ceramic types for restoration of endodontically treated teeth
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor - Consultant endodontist

Study Record Dates

First Submitted

April 1, 2018

First Posted

May 31, 2018

Study Start

July 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

November 4, 2021

Results First Posted

November 4, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

JO(1)