Back to resultsTetricCAD Crown Clinical Study
Primary Purpose
Fractured Tooth, Decayed Tooth, Unsatisfactory Restoration of Tooth
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tetric CAD
Sponsored by
About this trial
This is an interventional treatment trial for Fractured Tooth focused on measuring Crown, Ceramic, CAD/CAM
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 School of Dentistry
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tetric CAD Crown
Arm Description
Tetri CAD crowns will hand polished and cemented with a dual cured resin cement (Variolink Esthetic by Ivoclar Vivadent).
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 five 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
Patient described sensitivity on a scale of 1 to 4, where 1 means absence of sensitivity (pain) and four means severe discomfort noted routinely with cold or pressure stimulation.
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
NCT ID
NCT03716817
First Posted
October 21, 2018
Last Updated
September 6, 2023
Sponsor
University of Michigan
Collaborators
Ivoclar Vivadent AG
1. Study Identification
Unique Protocol Identification Number
NCT03716817
Brief Title
TetricCAD Crown Clinical Study
Official Title
Clinical Evaluation of Chairside CAD/CAM Resilient Ceramic Crowns
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
October 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Ivoclar Vivadent AG
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 new resin-based ceramic material for crowns. The material 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. 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 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 resilient ceramic CAD/CAM block(Tetric CAD/Ivoclar Vivadent). The crowns are placed using an adhesive bonding process including a total etch process with a universal adhesive (Adhese by Ivoclar Vivadent) and dual-cured resin cement (Variolink Esthetic by Ivoclar Vivadent). 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
Crown, Ceramic, CAD/CAM
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tetric CAD Crown
Arm Type
Experimental
Arm Description
Tetri CAD crowns will hand polished and cemented with a dual cured resin cement (Variolink Esthetic by Ivoclar Vivadent).
Intervention Type
Device
Intervention Name(s)
Tetric CAD
Intervention Description
Resilient ceramic crowns (Tetric CAD by Ivoclar Vivadent) are placed using an adhesive bonding process including a total etch process with a universal adhesive (Adhese by Ivoclar Vivadent) and dual cured resin cement (Variolink Esthetic by Ivoclar Vivadent).
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 five years.
Time Frame
from delivery of the crown up to 5 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
from delivery of the crown up to 5 years
Title
Tooth sensitivity
Description
Patient described sensitivity on a scale of 1 to 4, where 1 means absence of sensitivity (pain) and four means severe discomfort noted routinely with cold or pressure stimulation.
Time Frame
from delivery of the 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 the crown up to 5 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 Fasbinder, DDS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan School of Dentistry
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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TetricCAD Crown Clinical Study
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