TetricCAD Crown Clinical Study
NCT03716817 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-04-28
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.
Conditions
- Fractured Tooth
- Decayed Tooth
- Unsatisfactory Restoration of Tooth
Interventions
- DEVICE
-
Tetric CAD
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).
Sponsors & Collaborators
-
Ivoclar Vivadent AG
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Dennis Fasbinder, DDS · University of Michigan
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-10-01
- Primary Completion
- 2024-06-18
- Completion
- 2024-06-18
- FDA Device
- Yes
Countries
- United States
Study Locations
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