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Alternative EndoCrowns Designs for Chairside CAD/CAM

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ClinicalTrials.gov Identifier: NCT04604314
Recruitment Status : Enrolling by invitation
First Posted : October 27, 2020
Last Update Posted : September 29, 2021
Sponsor:
Collaborator:
Dentsply Sirona
Information provided by (Responsible Party):
Dennis J. Fasbinder, DDS, University of Michigan

Study Description
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Brief Summary:
This investigation will be a longitudinal clinical trial to study the association of preparation design on the internal and marginal adaptation of the resulting restorations and the long-term clinical performance of chairside CAD/CAM endocrown restorations. Advanced lithium disilicate chairside CAD/CAM endocrowns (CEREC Tessera/Dentsply Sirona) will be adhesively bonded using a selective enamel etch technique with a universal adhesive (Prime and Bond Elect/Dentsply Sirona) and a dual cure resin adhesive cement (Calibra Ceram/Dentsply Sirona). All restorations will be followed over five years of clinical service.

Condition or disease Intervention/treatment Phase
Endodontically Treated Teeth Device: CEREC Tessera Not Applicable

Detailed Description:

Endodontically treated teeth commonly present with extensive tooth structure loss due to caries, trauma, prior restorative treatment, and the endodontic access. These structural deficiencies lead to an increase in cusp deflection, crown fractures, microleakage, and decreased sensory feedback during function which greatly increases the possibility of tooth fracture.As a result, endodontically treated teeth require a full cuspal coverage restoration to prevent microleakage, restore function, and provide cuspal protection against tooth fracture. The most common restoration for endodontically treated teeth is core build-up, with or without a post, and full coverage crown.

This process requires multiple appointments with many technical steps ultimately leading to more chair time, treatment cost, and potential iatrogenic damage to the tooth. An alternative treatment is the endocrown, which utilizes the internal walls of the pulp chamber for macroretention and incorporates the core and crown in a monolithic restoration. The restoration is fabricated utilizing chairside CAD/CAM technology and is adhesively bonded to the tooth with resin cement. The EndoCrown restoration is more conservative relative to tooth structure loss, less expensive, and requires less chair time to complete when compared to conventional treatment while having comparable clinical longevity in molar teeth.

This investigation will be a longitudinal clinical trial to study the association of preparation design on the internal and marginal adaptation of the resulting restorations and the long-term clinical performance of chairside CAD/CAM endocrown restorations. Advanced lithium disilicate chairside CAD/CAM endocrowns (CEREC Tessera/Dentsply Sirona) will be adhesively bonded using a selective enamel etch technique with a universal adhesive (Prime and Bond Elect/Dentsply Sirona) and a dual cure resin adhesive cement (Calibra Ceram/Dentsply Sirona). All restorations will be followed over five years of clinical service.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Performance of Alternative Preparation Designs for Chairside CAD/CAM Fabricated Advanced Lithium Disilicate EndoCrowns
Actual Study Start Date : December 10, 2020
Estimated Primary Completion Date : December 1, 2026
Estimated Study Completion Date : December 1, 2027
Arms and Interventions
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Arm Intervention/treatment
Experimental: Endocrown Onlay Restoration
Endocrown onlay preparation = Buccal and lingual walls are intact with an occlusal-gingival height at least equal to half the original crown height of the tooth. Remaining buccal and lingual walls maintain a thickness ≥ 2.0 mm.
 Device: CEREC Tessera
Full ceramic endocrown restorations will be made from the high strength ceramic, CEREC Tessera
Experimental: Endocrown Shoulder Restorations
Endocrown shoulder preparation = Buccal and/or lingual walls are less than half the original occlusal-gingival height of the tooth or the buccal or lingual surfaces were previously prepared axially due to a prior restoration.
 Device: CEREC Tessera
Full ceramic endocrown restorations will be made from the high strength ceramic, CEREC Tessera


Outcome Measures
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Primary Outcome Measures :
  1. Restoration failure [ Time Frame: from delivery of the crown up to 5 years ]
    Restoration failure is scored by visual loss of the crown from the tooth requiring replacement of the study crown with a new crown at any time between delivery and five years.


Secondary Outcome Measures :
  1. Restoration loss of retention [ Time Frame: from delivery of crown up to 5 years ]
    Loss of retention is measured as visual detachment or dislodgment of the crown from the tooth without fracture of the crown requiring recementation of the crown.

  2. Margin staining [ Time Frame: from delivery of crown up to 5 years ]
    Margin staining is categorized based on modified US Public Health Service criteria using a four point scale where 1 is no staining and 4 is penetrating stain involving more than 50% of the margin.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject in need of final restoration following molar endodontic therapy
  2. Subject age 18 or above -

Exclusion Criteria:

  1. Teeth with remaining symptoms following endodontic therapy
  2. Teeth which have experienced endodontic complications to include treated perforations, internal or external resorption, or separated endodontic files.
  3. Teeth with exposure of the root canal filling material to the oral environment for greater than two weeks
  4. Teeth diagnosed with symptoms of incomplete tooth fracture
  5. Teeth with no adjacent or opposing tooth
  6. Teeth serving as an abutment for fixed or removable dental prostheses
  7. Subjects with uncontrolled bruxism or parafunctional habits
  8. Subject has known allergies to any product used in this study
  9. Subject will not be available for the study duration of 5 years
  10. Subjects with significant untreated dental disease to include periodontitis and rampant caries

  11. Women who self-report that they are pregnant or lactating

    -

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04604314


Locations
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United States, Michigan
School os Dentistry
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Dentsply Sirona
Investigators
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Principal Investigator: Dennis Fasbinder, DDS University of Michigan
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Dennis J. Fasbinder, DDS, Clinical Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT04604314    
Other Study ID Numbers: HUM00172803
First Posted: October 27, 2020    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Dennis J. Fasbinder, DDS, University of Michigan:
Crown
Ceramic
Endocrown
Additional relevant MeSH terms:
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Tooth, Nonvital
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases