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This clinical study is designed to compare the regenerative outcome of using separately two different Xenografts during sinus floor augmentation.
Aim of this prospective randomized-controlled clinical trial is to compare the regenerative results of Alpha-Bio's GRAFT Natural Bovine Bone versus commercially available bone graft after two-step sinus floor elevations by clinical and histological analysis.
Clinical Parameters are wound healing parameters, radiological volume stability and implant survival rates. Histological parameters are based on a histomorphometrical analysis of trephine cores harvested in progress of implant bed preparation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alpha-Bios GRAFT Natural Bovine Bone treatment | Experimental | Pure Hydroxyapatite ceramic mineral with high similarity to the human bone |
|
| natural bone substitute | Active Comparator | natural bone substitute material derived from the mineral portion of bovine bone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alpha-Bio GRAFT Natural Bovine Bone | Device | Pure Hydroxyapatite ceramic mineral with high similarity to the human bone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Histological bone formation following sinus floor augmentation [ evaluated by biopsies harvested from the implant sites] | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bone volume-stable results six months following augmentation procedures [ demonstrated by X-ray evaluation]. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Rothamel, Priv-Doz Dr. | Department of Craniomaxillofacial and Plastic Surgery University Hospital of Cologne | Principal Investigator |
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| Label | URL |
|---|---|
| Sponsor site | View source |
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| natural bone substitute | Device | natural bone substitute material derived from the mineral portion of bovine bone |
|