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| ID | Type | Description | Link |
|---|---|---|---|
| Sinus Lift Study |
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| Name | Class |
|---|---|
| FGK Clinical Research GmbH | INDUSTRY |
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The primary objective is the area of newly formed bone (%) as assessed by histomorphometry with either MD05 or beta-TCP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | MD05 |
|
| 2 | Active Comparator | Beta-TCP and autologous bone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MD05 | Drug | recombinant human GDF-5 coated onto beta-tricalcium phosphate |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area of newly formed mineralised bone tissue (%) as assessed by histomorphometry. | Within 4 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| evidence of uncompromised healing | January 2008 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wilfried Wagner, Prof Dr Dr | Universitätsklinikum Mainz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinik Erlangen | Erlangen | Bavaria | 91054 | Germany | ||
| Praxis Dr. Gath |
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| Beta-TCP and autologous bone |
| Device |
beta-tricalcium phosphate and autologous bone |
|
| München |
| Bavaria |
| 80336 |
| Germany |
| IPI München GmbH | München | Bavaria | 81925 | Germany |
| Praxis Dr. Schmidinger | Seefeld | Bavaria | 82229 | Germany |
| Universitätsklinik Düsseldorf | Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
| Klinikum der Universität Mainz | Mainz | Rheinland Pflaz | 55131 | Germany |
| Universitätsklinikum Schleswig Holstein | Kiel | Schleswig-Holstein | 24105 | Germany |
| Charité Universitätsmedizin Berlin | Berlin | State of Berlin | 12203 | Germany |
| Helios Klinik | Erfurt | Thuringia | 99089 | Germany |