Celtra Duo Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Dental Crown Study
NCT03036579 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 73
Last updated 2023-04-13
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.
Conditions
- Fractured Tooth
- Decayed Tooth
- Unsatisfactory Restoration of Tooth
Interventions
- DEVICE
-
Celtra Duo
Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.
Sponsors & Collaborators
-
Dentsply Sirona Inc.
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Dennis J Fasbinder, DDS · University of Michigan
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-11-30
- Primary Completion
- 2019-09-30
- Completion
- 2019-09-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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