Trials / Terminated
TerminatedNCT03036566
Lithium Disilicate (CAD/CAM) Fixed Partial Dentures (FPD) Clinical Study
Clinical Evaluation of Chairside Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Lithium Disilicate Fixed Partial Dentures (FPD)
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- University of Michigan · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Lithium disilicate ceramic (Ivoclar) | Three unit high strength ceramic bridges replacing a single tooth. |
Timeline
- Start date
- 2014-03-01
- Primary completion
- 2020-03-05
- Completion
- 2020-03-05
- First posted
- 2017-01-30
- Last updated
- 2024-07-25
- Results posted
- 2023-04-05
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03036566. Inclusion in this directory is not an endorsement.