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The purpose of this study is to compare a new biomaterial with an already existing treatment principle (Bio-Oss/Bio-Gide) with regard to their ability to preserve the dimensions of the alveolar ridge and to promote bone regeneration and to evaluate the early survival rate of dental implants placed in the augmented socket area and to assess radiographically and clinically changes of peri-implant soft and hard tissues.
This is prospective, randomized, single-blind, controlled, single center study. The total study duration for each patient should be 12 +/- 1 month.
In total 13 visits per patient are scheduled in this study.
The study devices Straumann Bone Ceramic and Bio-Oss are CE-marked, and approved by the FDA. The products are used within the indication.
One center in the Inited Kingdom will participate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Straumann Bone Ceramic | Experimental | Bone augmentation, after tooth extraction, with Straumann Bone Ceramic (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide. |
|
| Bio-Oss | Active Comparator | Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft)in combination with resorbable collagen membrane Bio-Gide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Straumann Bone Ceramic | Device | Bone augmentation, after tooth extraction, with Straumann Bone Ceramic (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide. |
| Measure | Description | Time Frame |
|---|---|---|
| The changes of bone level between baseline and 32 week post-extraction | baseline and 32 week post-extraction |
| Measure | Description | Time Frame |
|---|---|---|
| implant success and survival rate | 1 year post implant loading |
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Inclusion Criteria:
Exclusion Criteria:
Systemic exclusion criteria
Local exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Nikolaos Donos, DDS, MS, PhD | Eastman Dental Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastman Dental Institute, University College London | London | WC1X8LD | United Kingdom |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D014183 | Transplantation, Heterologous |
| ID | Term |
|---|---|
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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| Bio-Oss | Device | Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft)in combination with resorbable collagen membrane Bio-Gide. |
|
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