search
Back to results

Alternative EndoCrowns Designs for Chairside CAD/CAM

Primary Purpose

Endodontically Treated Teeth

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CEREC Tessera
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endodontically Treated Teeth focused on measuring Ceramic, Crown, Endocrown

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    -

Sites / Locations

  • School os Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Endocrown Onlay Restoration

Endocrown Shoulder Restorations

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Restoration failure
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

Restoration loss of retention
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.
Margin staining
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.

Full Information

First Posted
October 22, 2020
Last Updated
September 6, 2023
Sponsor
University of Michigan
Collaborators
Dentsply Sirona Implants and Consumables
search

1. Study Identification

Unique Protocol Identification Number
NCT04604314
Brief Title
Alternative EndoCrowns Designs for Chairside CAD/CAM
Official Title
Clinical Performance of Alternative Preparation Designs for Chairside CAD/CAM Fabricated Advanced Lithium Disilicate EndoCrowns
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 10, 2020 (Actual)
Primary Completion Date
December 1, 2026 (Anticipated)
Study Completion Date
December 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Dentsply Sirona Implants and Consumables

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontically Treated Teeth
Keywords
Ceramic, Crown, Endocrown

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endocrown Onlay Restoration
Arm Type
Experimental
Arm Description
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.
Arm Title
Endocrown Shoulder Restorations
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
CEREC Tessera
Intervention Description
Full ceramic endocrown restorations will be made from the high strength ceramic, CEREC Tessera
Primary Outcome Measure Information:
Title
Restoration failure
Description
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.
Time Frame
from delivery of the crown up to 5 years
Secondary Outcome Measure Information:
Title
Restoration loss of retention
Description
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.
Time Frame
from delivery of crown up to 5 years
Title
Margin staining
Description
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.
Time Frame
from delivery of crown up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject in need of final restoration following molar endodontic therapy Subject age 18 or above - Exclusion Criteria: Teeth with remaining symptoms following endodontic therapy Teeth which have experienced endodontic complications to include treated perforations, internal or external resorption, or separated endodontic files. Teeth with exposure of the root canal filling material to the oral environment for greater than two weeks Teeth diagnosed with symptoms of incomplete tooth fracture Teeth with no adjacent or opposing tooth Teeth serving as an abutment for fixed or removable dental prostheses Subjects with uncontrolled bruxism or parafunctional habits Subject has known allergies to any product used in this study Subject will not be available for the study duration of 5 years Subjects with significant untreated dental disease to include periodontitis and rampant caries Women who self-report that they are pregnant or lactating -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Fasbinder, DDS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
School os Dentistry
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Alternative EndoCrowns Designs for Chairside CAD/CAM

We'll reach out to this number within 24 hrs