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| Name | Class |
|---|---|
| Averion International Corporation | INDUSTRY |
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The purpose of this research study is to shorten the treatment time course for patients who are scheduled for surgery to have a dental implant(s) placed into the upper front part of their mouths and need to have more bone in their jaws to support the implant.
The INFUSEĀ® Bone Graft is a device approved by the FDA to be used instead of using your own bone (from another site on your body) to replace missing bone in your jaw. INFUSEĀ® Bone Graft is commercially available and is made up of 2 parts - recombinant human Bone Morphogenetic Protein-2 (rhBMP 2) placed on an absorbable collagen sponge (ACS). The rhBMP-2 is a genetically altered protein which recruits bone-forming cells to the surgical area and changes local cells to bone. ACS is made from Type I collagen from bovine (cattle) tendon. It helps to hold the rhBMP-2 in place and acts as a support for the growing bone. The sponge itself will reabsorb in time as the new bone forms.
The purpose of this research study is to shorten the treatment time course for the patients. This post-market study has been designed to further evaluate the effectiveness and safety of INFUSEĀ® Bone Graft, along with dental implant placement, in a single procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INFUSEĀ® Bone Graft | all study participants will receive INFUSEĀ® Bone Graft |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INFUSEĀ® Bone Graft | Device | Patients will be treated with the commercially available INFUSEĀ® Bone Graft material applied to an ACS in the area of the dental implant on Day 0 (Surgery). A follow-up visit will take place 2 weeks after implant of the INFUSEĀ® Bone Graft material, or as regularly scheduled as per the standard of care (SOC) for the facility. Patients will return to the facility for final End of Study (EOS) assessments 6 months after surgery for placement of the appropriate prosthetic, and assessment of osseointegration and stability. Between the follow-up visit and the EOS visit, patients will be seen as per the SOC schedule for the facility. |
| Measure | Description | Time Frame |
|---|---|---|
| Stability and osseointegration of endosseous dental implants | 6 months post-implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate evidence of successful initial INFUSEĀ® Bone Graft and dental implant placement. Assess percent bone fill within the defect and safety of INFUSEĀ®. Outcomes will be assessed via CT scans and periapical X-rays. | 6 months post-implantation |
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Inclusion Criteria:
Exclusion Criteria:
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Patients needing bone augmentation of the alveolar ridge prior to placement of dental implants
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda | California | 92350 | United States | |||
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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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| Los Angeles |
| California |
| 90095 |
| United States |
| Sarasota | Florida | 34237 | United States |
| Denver | North Carolina | 28037 | United States |
| Portland | Oregon | 97221 | United States |
| San Antonio | Texas | 78229 | United States |
| D010510 |
| Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |