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The objective of the study is to evaluate the clinical performance of Procera® Bridge Zirconia veneered with NobelRondo Zirconia.
The study was designed to be an open, 5-year, prospective, multi-center clinical post-market study. The objectives of this clinical study were that industrial centrally produced 3- or 4-unit bridges of yttrium-oxide partially-stabilized (Y-TZP) zirconia (Procera Zirconia) in combination with the veneering ceramic material NobelRondo will show sufficient CDA ratings (90% R+S) and a sufficient survival rate after 1 and 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Procera® Bridge Zirconia | Other | Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procera® Bridge Zirconia | Device | Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success Rate of Bridge Procera Bridge Zirconia | The CDA index (1) is Romeo or Sierra at delivery and remains so up to 1 year post loading. | prosthesis delivery, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Success Rate of Bridge Procera Bridge Zirconia | The CDA index (1) is Romeo or Sierra at delivery and remains so 5 year post loading. | prosthesis delivery, 5 years |
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Inclusion Criteria:
Exclusion criteria
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Association, C.D., Quality Evaluation for Dental Care. Guidelines for the Assessment of Clinical Quality and Professional Performance. Los Angeles: CDA, 1977. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Procera® Bridge Zirconia | Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible. Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Procera® Bridge Zirconia | Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible. Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Success Rate of Bridge Procera Bridge Zirconia | The CDA index (1) is Romeo or Sierra at delivery and remains so up to 1 year post loading. | 78 patients were treated in total. 4 of the patients received two bridges (which is complaint with the protocol). Therefore there are more bridges than patients. | Posted | Number | percentage of successful implants | prosthesis delivery, 1 year | bridges | Participants |
|
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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 | Procera® Bridge Zirconia | Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible. Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrhytmia | Cardiac disorders | Systematic Assessment | Deceased, no evidence for a device related complication is reported. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Porcelain fractures | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Trial Management | Nobel Biocare | +41 43 211 42 00 | isabelle.arrighi@nobelbiocare.com |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
| bridges |
|
|
|
| Secondary | Success Rate of Bridge Procera Bridge Zirconia | The CDA index (1) is Romeo or Sierra at delivery and remains so 5 year post loading. | 5 year data. Not all initially treated patients could be followed over the 5 years. | Posted | Number | percentage of successful implants | prosthesis delivery, 5 years | Number of Bridges analyzed | Participants |
|
|
|
| 3 |
| 80 |
| 38 |
| 80 |
|
| Heart disease | Cardiac disorders | Systematic Assessment | Deceased, no evidence for a device related complication is reported. |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Deceased, no evidence for a device related complication is reported. |
|
| occlusal adjustments | Surgical and medical procedures | Systematic Assessment |
|
| Periodontal problems | Surgical and medical procedures | Systematic Assessment |
|
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