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The purpose of this study is to examine the safety and usefulness of the Regenecure guided bone regeneration membrane for stimulating bone growth in patients that don't have enough bone for dental implant placement. The study will include 16 patients in each group, 20 non-smokers and 12 smokers, a total of 32 patients will participate in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regenecure AMCA GBR Dental membrane | Experimental | 16 patients will undergo the guided bone regeneration procedure using the Regenecure AMCA Membrane |
|
| Collagen membrane | Active Comparator | 16 patients will undergo the guided bone regeneration procedure using a commercially available collagen membrane |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regenecure AMCA GBR Dental Membrane | Device | Patients will undergo Guided Bone Regeneration (GBR) procedure using the Regenecure AMCA GBR Membrane |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone volume | Clinical effect on bone volume measured using CBCT. The volume of the newly formed bone will be evaluated by "subtraction" of the 2 cone beam CTs using digital measurements. | Change from Baseline in bone volume at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Histomorphometry | Specimens will be prepared for histological staining (H&E and Masson's trichrome stain). The stained samples will be evaluated for new bone, residual bone graft, marrow spaces and vascularity. | 6 months |
| Safety will be demonstrated by using VAS scale for pain measurements and if the PI will consider that any adverse event device related isn't clinically significant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michal Limor, MD | Contact | + 972-2-5401013 | michal@regenecure.co.il |
| Name | Affiliation | Role |
|---|---|---|
| Lior Shapira, PhD | Haddasah Medical Center, Jerusalem Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Periodontology Hadassah and Hebrew University Medical Center | Recruiting | Jerusalem | Israel |
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| ID | Term |
|---|---|
| D007575 | Jaw, Edentulous |
| D007576 | Jaw, Edentulous, Partially |
| ID | Term |
|---|---|
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
| D009066 | Mouth, Edentulous |
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| Geistlich Bio-GideĀ® collagen membrane | Device | The Geistlich Bio-GideĀ® collagen membrane, a commercially available product, will be used in 10 patients. |
|
Safety will be demonstrated by using VAS scale for pain measurements and if the PI will consider that any adverse event device related isn't clinically significant |
| six months |
| D009059 |
| Mouth Diseases |
| D014076 | Tooth Diseases |