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Since there are no clinical studies available comparing the gold standard (autogenous bone graft plus resorbable membrane) to the promising combination of xenogenic bone graft loaded with rhBMP-2 in combination with a collagen membrane for localized ridge augmentation, the present exploratory study has been designed.
The aim of the present study is therefore to test whether or not the application of a xenogenic bone block loaded with rhBMP-2 will results in clinically, radiographically and histologically similar outcomes as the gold standard (autogenous bone block) for the regeneration of chronic ridge defects.
The investigators expect that there is no difference in bone quantity and quality between the two methods and that the use of the test treatment will be more user and patient friendly according to the patient perception/acceptance since no second surgical site will be necessary as well as cause less complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group (A) | Active Comparator | Bone augmentation will be performed using autogenous bone from the retromolar or chin area followed by a fixation with titanium screws at the recipients site; filled with deproteinized bovine bone mineral (DBBM) particles (Bio-Oss®, Geistlich Pharma AG, Wolhusen, Switzerland) and covered with a collagen membrane (Bio-Gide®, Geistlich Pharma AG, Switzerland). These course of action is well documented in the literature and standard procedures. |
|
| Test group (B) | Experimental | The bone augmentation will be performed using a deproteinized bovine bone mineral (DBBM) block (Bio-Oss Spongiosa Block®, Geistlich Parma AG, Wolhusen, Switzerland) and a collagen membrane (Bio-Gide®, Geistlich Pharma AG, Switzerland) similarly to the control group. In addition, DBBM will be loaded with rhBMPH-2 (InductOs®, Pfizer AG, Zurich, Switzerland). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autogenous bone graft | Device | Bone augmentation will be performed using autogenous bone from the retromolar or chin area followed by a fixation with titanium screws at the recipients site; filled with deproteinized bovine bone mineral (DBBM) particles (Bio-Oss®, Geistlich Pharma AG, Wolhusen, Switzerland) and covered with a collagen membrane (Bio-Gide®, Geistlich Pharma AG, Switzerland) |
| Measure | Description | Time Frame |
|---|---|---|
| Bone quality/quantity | Bone quantity at 4 months after augmentation surgery, measured manually by ridge measurements and volumetrically on the basis of optical impressions and radiological assessment (X-ray and cone beam CT). Bone quality at 4 months after augmentation surgery, measured by histological assessment (yields different proportion per patient). | 4 month after augmentation surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Complications (soft tissue, sensitivity) measured at suture removal (8 days after augmentation surgery) and 4 months after augmentation surgery. Any adverse events will be recorded for the treatment period from visit 1 to 4. | 8 days and 4 month after augmentation surgery |
| Bone quantity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel S Thoma, Prof. Dr. | Clinic of Reconstructive Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oral Surgery & Radiology, Dental School, Medical University of Graz | Graz | Austria | ||||
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|
| InductOs | Drug | CE-marked medical device Bio-Oss Spongiosa Block® (xenogenic bone) loaded with InductOs® (1.5 mg Dibotermin alfa / ml) covered with Bio-Gide® (collagen membrane). One time application at augmentation surgery. |
|
| Augmentation surgery | Procedure | CE-marked medical device Bio-Oss Spongiosa Block® (xenogenic bone) loaded with InductOs® (1.5 mg Dibotermin alfa / ml) covered with Bio-Gide® (collagen membrane) |
|
Bone quantity measured at screening, augmentation surgery, suture removal, and during follow-up |
| at screening, augmentation surgery, suture removal, and during follow-up |
| Patient's perception/acceptance | Patient's perception/acceptance (visual analogue scale VAS) measured at suture removal (8 days after augmentation surgery) | 8 days after augmentation surgery |
| Center of Dental Medicine Clinic of Reconstructive Dentistry |
| Zurich |
| 8032 |
| Switzerland |
| ID | Term |
|---|---|
| D000848 | Anodontia |
| ID | Term |
|---|---|
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D055396 | Bone Morphogenetic Protein 2 |
| ID | Term |
|---|---|
| D019485 | Bone Morphogenetic Proteins |
| D055411 | TGF-beta Superfamily Proteins |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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