Lithium Disilicate (CAD/CAM) Fixed Partial Dentures (FPD) Clinical Study
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Bridge Three unit high strength ceramic (lithium disilicate/emaxCAD by Ivoclar) bridges replacing a single tooth. |
Device: Lithium disilicate ceramic (Ivoclar)
Three unit high strength ceramic bridges replacing a single tooth.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Bridge failure [from delivery of the bridge up to 5 years]
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 [from delivery of the bridge up to 5 years]
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 [from delivery of the bridge up to 5 years]
Patient described tooth 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 [from delivery of the bridge up to 5 years]
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 of each of the abutment teeth.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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healthy periodontal status for the adjacent abutment teeth with 1:1 crown:root ratio
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abutment teeth must be asymptomatic prior to treatment
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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.
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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:
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sensitive abutment teeth
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teeth with a history of direct or indirect pulp capping procedures
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patients with significant untreated dental disease to include periodontitis and caries
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pregnant or lactating women
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patients with allergies to any material in the study
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patients unable to return for recall appointments
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan
- Ivoclar Vivadent AG
Investigators
- Principal Investigator: Dennis J Fasbinder, DDS, University of Michigan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUM00081086