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Loss of funding due to COVID-19
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| Name | Class |
|---|---|
| Ivoclar Vivadent AG | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bridge | Experimental | Three unit high strength ceramic (lithium disilicate/emaxCAD by Ivoclar) bridges replacing a single tooth. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lithium disilicate ceramic (Ivoclar) | Device | Three unit high strength ceramic bridges replacing a single tooth. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from delivery of the bridge up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from delivery of the bridge up to 5 years |
| Number of Bridges Associate With Tooth Sensitivity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis J Fasbinder, DDS | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bridge | Three unit high strength ceramic (lithium disilicate/emaxCAD by Ivoclar) bridges replacing a single tooth. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bridge | Three unit high strength ceramic (lithium disilicate/emaxCAD by Ivoclar) bridges replacing a single tooth. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age was not collected from any participant. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | number of bridges | from delivery of the bridge up to 5 years |
|
|
5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bridge | Three unit high strength ceramic (lithium disilicate/emaxCAD by Ivoclar) bridges replacing a single tooth. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dennis J. Fasbinder, DDS | University of Michigan | 7346474450 | djfas@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 23, 2022 | Jan 26, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000848 | Anodontia |
| ID | Term |
|---|---|
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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| ID | Term |
|---|---|
| D003830 | Denture, Partial, Fixed |
| ID | Term |
|---|---|
| D003829 | Denture, Partial |
| D003778 | Dentures |
| D017266 | Dental Prosthesis |
| D011476 | Prosthodontics |
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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. |
| from delivery of the bridge up to 5 years |
| Number of Bridges Associated With 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. | from delivery of the bridge up to 5 years |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
| Secondary | 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. | Posted | Number | number of bridges | from delivery of the bridge up to 5 years |
|
|
|
| Secondary | Number of Bridges Associate With 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. | number of bridges | Posted | Number | number of bridges | from delivery of the bridge up to 5 years |
|
|
|
| Secondary | Number of Bridges Associated With 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. | number of bridges | Posted | Number | number of bridges | from delivery of the bridge up to 5 years |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003813 |
| Dentistry |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |