Survival of Endocrowns Made From Different Ceramics

Sponsor
University of Jordan (Other)
Overall Status
Completed
CT.gov ID
NCT03542019
Collaborator
(none)
60
Enrollment
1
Location
3
Arms
30
Actual Duration (Months)
2
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Dental prosthesis
  • Device: Dental crown
  • Device: Hybrid ceramic
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Three different ceramic types for restoration of endodontically treated teethThree different ceramic types for restoration of endodontically treated teeth
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
All ceramic materials will be assigned randomly by research assistant who has randomised tables generated by a statistician
Primary Purpose:
Treatment
Official Title:
The Endocrown; a Prospective Randomised Clinical Trial of Three Different Ceramics
Actual Study Start Date :
Jul 1, 2018
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Dec 31, 2020

Arms and Interventions

ArmIntervention/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
  • Outcome Measures

    Primary Outcome Measures

    1. Survival of Dental Prosthesis [24 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Jordan University HospitalAmmanJordan11831

    Sponsors and Collaborators

    • University of Jordan

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmad El-Ma'aita, Assistant Professor - Consultant endodontist, University of Jordan
    ClinicalTrials.gov Identifier:
    NCT03542019
    Other Study ID Numbers:
    • 10/2017/25289
    First Posted:
    May 31, 2018
    Last Update Posted:
    Nov 4, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleLithium DisilicateMonolithic ZirconiaHybrid Ceramic
    Arm/Group DescriptionLithium 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 Dental prosthesis: Replacement of missing tooth structure using Lithium disilicate porcelainMonolithic 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 Dental crown: Replacement og missing tooth structure using monolithic zirconiaHybrid 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 Hybrid ceramic: Restroration of endodontically treated teeth using hybrid ceramic
    Period Title: Overall Study
    STARTED202020
    COMPLETED191719
    NOT COMPLETED131

    Baseline Characteristics

    Arm/Group TitleLithium DisilicateMonolithic ZirconiaHybrid CeramicTotal
    Arm/Group DescriptionLithium 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 Dental prosthesis: Replacement of missing tooth structure using Lithium disilicate porcelainMonolithic 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 Dental crown: Replacement og missing tooth structure using monolithic zirconiaHybrid 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 Hybrid ceramic: Restroration of endodontically treated teeth using hybrid ceramicTotal of all reporting groups
    Overall Participants20202060
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    30.8
    (10.6)
    38.1
    (14.9)
    33.4
    (11.2)
    34.1
    (12.6)
    Sex: Female, Male (Count of Participants)
    Female
    15
    75%
    13
    65%
    11
    55%
    39
    65%
    Male
    5
    25%
    7
    35%
    9
    45%
    21
    35%
    Race and Ethnicity Not Collected (Count of Participants)
    Count of Participants [Participants]
    0
    0%
    Region of Enrollment (participants) [Number]
    Jordan
    20
    100%
    20
    100%
    20
    100%
    20
    33.3%

    Outcome Measures

    1. Primary Outcome
    TitleSurvival of Dental Prosthesis
    DescriptionThe endocrowns (the dental prosthesis studied) were assessed after 24 months. Those that were functional and without any symptoms were considered surviving.
    Time Frame24 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleLithium DisilicateMonolithic ZirconiaHybrid Ceramic
    Arm/Group DescriptionLithium 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 Dental prosthesis: Replacement of missing tooth structure using Lithium disilicate porcelainMonolithic 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 Dental crown: Replacement og missing tooth structure using monolithic zirconiaHybrid 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 Hybrid ceramic: Restroration of endodontically treated teeth using hybrid ceramic
    Measure Participants161718
    Measure Teeth191719
    Count of Units [Teeth]
    19
    14
    17

    Adverse Events

    Time Frame24 months
    Adverse Event Reporting Description Debonding, fracture, poor appearance, or if the tooth was deemed non-restorable during the 24-month observation period.
    Arm/Group TitleLithium DisilicateMonolithic ZirconiaHybrid Ceramic
    Arm/Group DescriptionLithium 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 Dental prosthesis: Replacement of missing tooth structure using Lithium disilicate porcelainMonolithic 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 Dental crown: Replacement og missing tooth structure using monolithic zirconiaHybrid 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 Hybrid ceramic: Restroration of endodontically treated teeth using hybrid ceramic
    All Cause Mortality
    Lithium DisilicateMonolithic ZirconiaHybrid Ceramic
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/20 (0%) 0/20 (0%) 0/20 (0%)
    Serious Adverse Events
    Lithium DisilicateMonolithic ZirconiaHybrid Ceramic
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/20 (0%) 0/20 (0%) 0/20 (0%)
    Other (Not Including Serious) Adverse Events
    Lithium DisilicateMonolithic ZirconiaHybrid Ceramic
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/20 (0%) 3/20 (15%) 2/20 (10%)
    Product Issues
    Debonding0/20 (0%) 03/20 (15%) 32/20 (10%) 2

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleDr. Ahmad El-Ma'aita
    OrganizationUniversity of Jordan
    Phone+9626535 5000
    Emaila.maaita@ju.edu.jo
    Responsible Party:
    Ahmad El-Ma'aita, Assistant Professor - Consultant endodontist, University of Jordan
    ClinicalTrials.gov Identifier:
    NCT03542019
    Other Study ID Numbers:
    • 10/2017/25289
    First Posted:
    May 31, 2018
    Last Update Posted:
    Nov 4, 2021
    Last Verified:
    Oct 1, 2021