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| Name | Class |
|---|---|
| Johnson & Johnson | INDUSTRY |
| OraPharma | INDUSTRY |
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The purpose of this study is to evaluate clinically, histologically and radiographically the healing of extraction sockets covered with a resorbable collagen membrane (OSSIX-Plus) 12 weeks following exodontia.
Reduction in alveolar ridge height and width may prohibit optimal implant placement, and often compromises the esthetic and functional result. Alveolar ridge preservation has been evaluated in many studies. A variety of bone grafting materials and barrier membranes have been studied for their ability to enhance bone formation in damaged alveolar ridges, and to evaluate their bone healing and bone-forming capacity in extraction sockets. However, the newly developed resorbable collagen membrane OSSIX-Plus has not been evaluated for this purpose. This study is designed to test the ability of OSSIX-Plus (OraPharma Inc., Warminster, Pennsylvania) in promoting optimal bone healing following exodontia. We hypothesize that use of OSSIX-Plus will result in preservation of the height, width and density of the residual alveolar ridge following tooth extraction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placing OSSIX-Plus in Extraction Site | Experimental | Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OSSIX-Plus | Device | resorbable collagen membrane |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bone Gain or Loss in Millimeters (Buccopalatal) | Socket width (buccopalatal) measured by a calibrated examiner using a University of North Carolina (UNC) probe. | From Baseline to 12 weeks |
| Change in Bone Gain or Loss in Millimeters (Mesiodistal) | Socket width (mesiodistal) measured by a calibrated examiner using a University of North Carolina (UNC) probe. | From Baseline to 12 weeks |
| Change in Bone Gain or Loss in Millimeters (Stent to Apex) | Stent to apex of socket measured by a calibrated examiner using a University of North Carolina (UNC) probe. | From Baseline to 12 weeks |
| Radiographic Bone Changes | Radiographic measures were accomplished utilizing a real-time subtraction program, Computer Assisted Radiographic Evaluation (C.A.R.E.). | From Baseline to 12 weeks |
| New Bone Formation | Percentage of new bone formation of the alveolar bone core biopsies. | From Baseline to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William V Giannobile, DDS, DMedSc | Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michigan Center for Oral Health Research | Ann Arbor | Michigan | 48106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21845241 | Result | Neiva R, Pagni G, Duarte F, Park CH, Yi E, Holman LA, Giannobile WV. Analysis of tissue neogenesis in extraction sockets treated with guided bone regeneration: clinical, histologic, and micro-CT results. Int J Periodontics Restorative Dent. 2011 Sep-Oct;31(5):457-69. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placing OSSIX-Plus in Extraction Site | Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia. OSSIX-Plus: resorbable collagen membrane |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placing OSSIX-Plus in Extraction Site | Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia. OSSIX-Plus: resorbable collagen membrane |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Bone Gain or Loss in Millimeters (Buccopalatal) | Socket width (buccopalatal) measured by a calibrated examiner using a University of North Carolina (UNC) probe. | Posted | Mean | Full Range | mm | From Baseline to 12 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placing OSSIX-Plus in Extraction Site | Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia. OSSIX-Plus: resorbable collagen membrane |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. William Giannobile, Chair Department of Periodontics and Oral Medicine | University of Michigan School of Dentistry | 734-763-2105 | wgiannob@umich.edu |
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| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Socket width (buccopalatal) | Mean | Full Range | mm |
|
| Socket width (meiodistal) | Mean | Full Range | mm |
|
| Stent to buccal plate | Mean | Full Range | mm |
|
| Stent to mesial osseous crest | Mean | Full Range | mm |
|
| Stent to distal osseous crest | Mean | Full Range | mm |
|
| Stent to midosseous crest | Mean | Full Range | mm |
|
| Stent to apex of socket | Median | Full Range | mm |
|
|
| Primary | Change in Bone Gain or Loss in Millimeters (Mesiodistal) | Socket width (mesiodistal) measured by a calibrated examiner using a University of North Carolina (UNC) probe. | Posted | Mean | Full Range | mm | From Baseline to 12 weeks |
|
|
|
| Primary | Change in Bone Gain or Loss in Millimeters (Stent to Apex) | Stent to apex of socket measured by a calibrated examiner using a University of North Carolina (UNC) probe. | Posted | Mean | Full Range | mm | From Baseline to 12 weeks |
|
|
|
| Primary | Radiographic Bone Changes | Radiographic measures were accomplished utilizing a real-time subtraction program, Computer Assisted Radiographic Evaluation (C.A.R.E.). | Posted | Mean | Full Range | percentage of bone fill | From Baseline to 12 weeks |
|
|
|
| Primary | New Bone Formation | Percentage of new bone formation of the alveolar bone core biopsies. | Posted | Mean | Full Range | percentage of vital bone | From Baseline to 12 weeks |
|
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| 0 |
| 10 |
| 0 |
| 10 |
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| D010510 |
| Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |