Pilot Study on Safety and Efficacy of MD05 in Comparison With Beta-TCP in Patients Undergoing Sinus Floor Augmentation
NCT00520377 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31
Last updated 2008-04-23
Summary
The primary objective is the area of newly formed bone (%) as assessed by histomorphometry with either MD05 or beta-TCP.
Conditions
- Alveolar Ridge Augmentation
Interventions
- DRUG
-
MD05
recombinant human GDF-5 coated onto beta-tricalcium phosphate
- DEVICE
-
Beta-TCP and autologous bone
beta-tricalcium phosphate and autologous bone
Sponsors & Collaborators
-
FGK Clinical Research GmbH
collaborator INDUSTRY -
Scil Technology GmbH
lead INDUSTRY
Principal Investigators
-
Wilfried Wagner, Prof Dr Dr · Universitätsklinikum Mainz
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-01-31
- Primary Completion
- 2007-12-31
- Completion
- 2008-05-31
Countries
- Germany
Study Locations
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