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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT-No.: 2006-005883-25 |
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| Name | Class |
|---|---|
| FGK Clinical Research GmbH | INDUSTRY |
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The purpose of the study is to gain experience of safety and efficacy with MD05 in man in alveolar bone regeneration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Open flap debridement + MD05 |
|
| 2 | Active Comparator | Open flap debridement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MD05 and open flap debridement | Drug | recombinant human GDF-5 coated onto ß-tricalcium phosphate |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of regeneration of alveolar bone. | October 2008 |
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of uncompromised healing. | October 2008 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anton Sculean, Prof. | Department of Periodontology; Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Periodontology, Semmelweis University Budapest | Budapest | Budapest | 1085 | Hungary |
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| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
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| Open flap debridement |
| Procedure |
Open flap debridement alone |
|
| D010510 |
| Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |