Back to resultsLithium Disilicate (CAD/CAM) Fixed Partial Dentures (FPD) Clinical Study
Primary Purpose
Missing Tooth
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lithium disilicate ceramic (Ivoclar)
Sponsored by
About this trial
This is an interventional treatment trial for Missing Tooth
Eligibility Criteria
Inclusion Criteria:
- missing one anterior or premolar tooth that is appropriate for replacement with a bridge. The second premolar tooth will be the most distal tooth acceptable as a pontic for inclusion in the study.
- healthy periodontal status for the adjacent abutment teeth with 1:1 crown:root ratio
- abutment teeth must be asymptomatic prior to treatment
- Endodontically treated teeth will be acceptable for abutments as long as nonmetallic cores can be placed to retain the FPD since the lithium disilicate will be bonded to the abutments.
- no more than one bridge will be placed per patient. If a patient presents with more than one missing teeth acceptable for the study, premolar teeth will be included prior to anterior teeth. Each bridge will be three units and include only one missing tooth.
Exclusion Criteria:
- sensitive abutment teeth
- teeth with a history of direct or indirect pulp capping procedures
- patients with significant untreated dental disease to include periodontitis and caries
- pregnant or lactating women
- patients with allergies to any material in the study
- patients unable to return for recall appointments
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bridge
Arm Description
Three unit high strength ceramic (lithium disilicate/emaxCAD by Ivoclar) bridges replacing a single tooth.
Outcomes
Primary Outcome Measures
Bridge Failure
Bridge failure includes fracture of the bridge or loss of the bridge requiring placement of a new bridge at any time between delivery and five years.
Secondary Outcome Measures
Bridge Loss of Retention
Loss of retention is measured as detachment of the bridge from the teeth without fracture of the bridge requiring recementation of the bridge.
Tooth Sensitivity
Tooth Sensitivity is evaluated as either "0" if the subject reports that there is NO sensitivity for either tooth with the study bridge, or "1" if the subject reports that there IS tooth sensitivity to hot/cold or biting pressure for either tooth supporting the bridge. The better outcome is to have NO tooth sensitivity.
Margin Staining
Margin Staining is evaluated as either "0" if there is NO staining at the crown margin where it meets the tooth for either tooth supporting the bridge, or "1" if there IS staining at the crown margin where it meets the tooth for either tooth supporting the bridge. The better outcome is to have NO margin staining.
Full Information
NCT ID
NCT03036566
First Posted
January 26, 2017
Last Updated
March 8, 2023
Sponsor
University of Michigan
Collaborators
Ivoclar Vivadent AG
1. Study Identification
Unique Protocol Identification Number
NCT03036566
Brief Title
Lithium Disilicate (CAD/CAM) Fixed Partial Dentures (FPD) Clinical Study
Official Title
Clinical Evaluation of Chairside Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Lithium Disilicate Fixed Partial Dentures (FPD)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Loss of funding due to COVID-19
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 5, 2020 (Actual)
Study Completion Date
March 5, 2020 (Actual)
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 high strength ceramic material for bridges to replace missing teeth. The ceramic material has been approved by the FDA for patient treatment. A computer technique will be used to make the bridges. The bridges will be cemented using an adhesive resin cement (MultiLink Automix/Ivoclar). The bridges are planned be evaluated for clinical performance at 6 months, 1 year, 2 years, 3 years, and if funding permits, 4 years, and 5 years. The purpose of the study is to measure how well the high strength bridges function over an extended period of time.
Detailed Description
The study will be composed of 30 bridges placed in adult patients that have been identified as requiring replacement of a single tooth. All the bridges will be made from the same high strength ceramic material (emaxCAD/Ivoclar) using a computer to make the entire bridge. All the crowns will be cemented using the most current marketed version of the manufacturer's adhesive resin cement (MultiLink Automix/Ivoclar). At each recall appointment an evaluation of the bridge will be completed as well as clinical photographs, an intraoral digital scan, and impression of the bridge. The purpose of the study is to measure how well the high strength bridges function over an extended period of time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Missing Tooth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bridge
Arm Type
Experimental
Arm Description
Three unit high strength ceramic (lithium disilicate/emaxCAD by Ivoclar) bridges replacing a single tooth.
Intervention Type
Device
Intervention Name(s)
Lithium disilicate ceramic (Ivoclar)
Other Intervention Name(s)
fixed partial denture
Intervention Description
Three unit high strength ceramic bridges replacing a single tooth.
Primary Outcome Measure Information:
Title
Bridge Failure
Description
Bridge failure includes fracture of the bridge or loss of the bridge requiring placement of a new bridge at any time between delivery and five years.
Time Frame
from delivery of the bridge up to 5 years
Secondary Outcome Measure Information:
Title
Bridge Loss of Retention
Description
Loss of retention is measured as detachment of the bridge from the teeth without fracture of the bridge requiring recementation of the bridge.
Time Frame
from delivery of the bridge up to 5 years
Title
Tooth Sensitivity
Description
Tooth Sensitivity is evaluated as either "0" if the subject reports that there is NO sensitivity for either tooth with the study bridge, or "1" if the subject reports that there IS tooth sensitivity to hot/cold or biting pressure for either tooth supporting the bridge. The better outcome is to have NO tooth sensitivity.
Time Frame
from delivery of the bridge up to 5 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 for either tooth supporting the bridge, or "1" if there IS staining at the crown margin where it meets the tooth for either tooth supporting the bridge. The better outcome is to have NO margin staining.
Time Frame
from delivery of the bridge up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
missing one anterior or premolar tooth that is appropriate for replacement with a bridge. The second premolar tooth will be the most distal tooth acceptable as a pontic for inclusion in the study.
healthy periodontal status for the adjacent abutment teeth with 1:1 crown:root ratio
abutment teeth must be asymptomatic prior to treatment
Endodontically treated teeth will be acceptable for abutments as long as nonmetallic cores can be placed to retain the FPD since the lithium disilicate will be bonded to the abutments.
no more than one bridge will be placed per patient. If a patient presents with more than one missing teeth acceptable for the study, premolar teeth will be included prior to anterior teeth. Each bridge will be three units and include only one missing tooth.
Exclusion Criteria:
sensitive abutment teeth
teeth with a history of direct or indirect pulp capping procedures
patients with significant untreated dental disease to include periodontitis and caries
pregnant or lactating women
patients with allergies to any material in the study
patients unable to return for 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
Learn more about this trial
Lithium Disilicate (CAD/CAM) Fixed Partial Dentures (FPD) Clinical Study
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