Celtra Duo Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Dental Crown Study
Primary Purpose
Fractured Tooth, Decayed Tooth, Unsatisfactory Restoration of Tooth
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Celtra Duo
Sponsored by
About this trial
This is an interventional treatment trial for Fractured Tooth focused on measuring CAD/CAM, Ceramic, Crown
Eligibility Criteria
Inclusion Criteria:
- must have at least one carious lesion or defective restoration or fractured tooth in a molar or premolar
- reason for restoration should extend more than one-half the intercuspal width of the tooth requiring a full crown restoration
- Teeth to be vital and asymptomatic prior to treatment
- No more than two restorations will be placed per patient. If a patient presents with more than two acceptable teeth for the study, molar teeth will be included prior to premolar teeth.
Exclusion Criteria:
- Devital or sensitive teeth
- Teeth with prior endodontic treatment of any kind
- Teeth with a history of direct or indirect pulp capping procedures
- Patients with significant untreated dental disease to include periodontitis and rampant caries
- Pregnant or lactating women
- Patients with a history of allergies to any of the materials to be used in the study
- Patients unable to return for the recall appointments
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Glazed Fired, Calibra Céram
Hand Polished, Calibra Universal
Arm Description
Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement
Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement
Outcomes
Primary Outcome Measures
Crown Failure
Crown failure includes fracture of the crown or loss of the crown requiring placement of a new crown at any time between delivery and three years.
Secondary Outcome Measures
Crown Loss of Retention
Loss of retention is measured as detachment of the crown from the tooth without fracture of the crown requiring recementation of the crown.
Tooth Sensitivity
Tooth Sensitivity is evaluated as either "0" if the subject reports that there is NO sensitivity for the tooth with the study crown, or "1" if the subject reports that there IS tooth sensitivity to hot/cold or biting pressure. The better outcome is to have NO tooth sensitivity. The number of teeth with tooth sensitivity are listed below.
Margin Staining
Margin Staining is evaluated as either "0" if there is NO staining at the crown margin where it meets the tooth, or "1" if there IS staining at the crown margin where it meets the tooth. The better outcome is to have NO margin staining. The number of teeth with margin staining are listed below.
Full Information
NCT ID
NCT03036579
First Posted
January 26, 2017
Last Updated
March 23, 2023
Sponsor
University of Michigan
Collaborators
Dentsply Sirona Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03036579
Brief Title
Celtra Duo Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Dental Crown Study
Official Title
Clinical Evaluation of Chairside Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Zirconia-reinforced Lithium Silicate Ceramic Crowns
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
COVID, loss of funding
Study Start Date
November 2015 (undefined)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
September 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Dentsply Sirona Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This investigation will be a clinical trial to study the performance of a newly developed high strength ceramic material for crowns. The ceramic has been approved by the FDA for patient treatment. A computer technique will be used to fabricate the crowns in a single appointment without the need for a temporary crown or second appointment. Two adhesive resin cement techniques will be used to hold the crown to the tooth and they will be evaluated for creating sensitivity to the tooth. The purpose of the study is to measure how well the high strength crowns function over an extended period of time.
Detailed Description
The study will be composed of two groups of 50 crowns placed in adult patients that have been identified as requiring at least one crown on a posterior tooth. A maximum of two crowns per patient will be completed. All the crowns will be made from the same high strength ceramic material (Celtra Duo/Dentsply Sirona). The two groups of crowns will be made using two different processes to create the surface texture and finish for the crown. One group of Celtra Duo crowns (Group 1) will be glaze-fired in a porcelain oven and the second group (Group 2) will be hand-polished. All the crowns will be cemented using two adhesive techniques. All of the oven-fired, glazed crowns will be cemented using the self-etching, self-adhesive resin cement technique (Calibra Universal Cement/Dentsply). All of the hand polished crowns will be cemented using an adhesive bonding technique using Prime & Bond Elect (Dentsply) with a dual cured resin cement (Calibra Ceram/Dentsply). The crowns are planned to be evaluated at 6 months, 1 year, 2 years, 3 years, and if funding permits, 4 years, and 5 years. At each appointment an examination of the crown will be completed as well as clinical photographs, an intraoral digital scan, and impression of the crown.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractured Tooth, Decayed Tooth, Unsatisfactory Restoration of Tooth
Keywords
CAD/CAM, Ceramic, Crown
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Masking Description
Final surface fabrication was not identified in the treatment process until the crown was milled.
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glazed Fired, Calibra Céram
Arm Type
Experimental
Arm Description
Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement
Arm Title
Hand Polished, Calibra Universal
Arm Type
Experimental
Arm Description
Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement
Intervention Type
Device
Intervention Name(s)
Celtra Duo
Intervention Description
Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.
Primary Outcome Measure Information:
Title
Crown Failure
Description
Crown failure includes fracture of the crown or loss of the crown requiring placement of a new crown at any time between delivery and three years.
Time Frame
from delivery of the crown up to 3 years
Secondary Outcome Measure Information:
Title
Crown Loss of Retention
Description
Loss of retention is measured as detachment of the crown from the tooth without fracture of the crown requiring recementation of the crown.
Time Frame
3 years
Title
Tooth Sensitivity
Description
Tooth Sensitivity is evaluated as either "0" if the subject reports that there is NO sensitivity for the tooth with the study crown, or "1" if the subject reports that there IS tooth sensitivity to hot/cold or biting pressure. The better outcome is to have NO tooth sensitivity. The number of teeth with tooth sensitivity are listed below.
Time Frame
3 years
Title
Margin Staining
Description
Margin Staining is evaluated as either "0" if there is NO staining at the crown margin where it meets the tooth, or "1" if there IS staining at the crown margin where it meets the tooth. The better outcome is to have NO margin staining. The number of teeth with margin staining are listed below.
Time Frame
from delivery of the crown up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
must have at least one carious lesion or defective restoration or fractured tooth in a molar or premolar
reason for restoration should extend more than one-half the intercuspal width of the tooth requiring a full crown restoration
Teeth to be vital and asymptomatic prior to treatment
No more than two restorations will be placed per patient. If a patient presents with more than two acceptable teeth for the study, molar teeth will be included prior to premolar teeth.
Exclusion Criteria:
Devital or sensitive teeth
Teeth with prior endodontic treatment of any kind
Teeth with a history of direct or indirect pulp capping procedures
Patients with significant untreated dental disease to include periodontitis and rampant caries
Pregnant or lactating women
Patients with a history of allergies to any of the materials to be used in the study
Patients unable to return for the recall appointments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis J Fasbinder, DDS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Celtra Duo Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Dental Crown Study
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