Status:
TERMINATED
Localized Alveolar Ridge Augmentation With Space Maintenance Devices
Lead Sponsor:
Medtronic Spinal and Biologics
Collaborating Sponsors:
Averion International Corporation
Conditions:
Alveolar Bone Loss
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this research study is to determine whether this study treatment can improve the bone structure of the upper front part of the jaw in patients who are scheduled for surgery to have a de...
Detailed Description
The INFUSE® 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. INFUSE® Bone Graft is commerciall...
Eligibility Criteria
Inclusion
- Able to provide written informed consent
- ≥ 18 years
- Scheduled for dental implant into anterior maxillary alveolar ridge
- Negative urine pregnancy test for patients of child bearing potential and agreement not to become pregnant for at least 12 months after surgery
- Able to comply with all study-related procedures, including exercising good oral hygiene
- A prosthodontic treatment plan has been drafted.
Exclusion
- Known hypersensitivity to rhBMP-2, bovine Type I collagen or other components of the formulation
- Known hypersensitivity to titanium
- Operative site is in the area of a resected or extant tumor
- Any active malignancy or current treatment for a malignancy
- Active infection at operative site
- History of prior exposure to rhBMP-2/ACS
- Received and failed a previous alveolar ridge augmentation procedure
- Pathology that would either compromise a bone grafting procedure, or interfere with obtaining quantitative measurements from postoperative computer tomography scans
- Significant untreated periodontal disease (\> Grade III), caries, or chronic inflammation of the oral cavity at operative site
- Active use of any nicotine-containing products such as, but not limited to, smoking and chewing tobacco, nicotine patch, nicotine gum, etc.
- Insulin-dependent diabetic, or has known glycated hemoglobin (HgbA1c) levels \>6.5 %
- History of malignancy within the past 5 years except for basal cell or squamous cell carcinoma of the skin
- Patients who are lactating
- History of metabolic bone disease, excluding idiopathic osteoporosis
- History of autoimmune disease (e.g., documented multiple allergies, systemic lupus erythematosus, dermatomyositis, etc.) or immunosuppressive disease (e.g., human immunodeficiency virus or acquired immunodeficiency syndrome)
- History of immune deficiency due to other treatments (e.g., radiation therapy, chemotherapy, steroid therapy)
- History of adverse reaction to prior exposure to silicone or injectable collagen
- Treatment with an investigational therapy within 1 month before the surgical procedure or plans to be treated with an investigational therapy during the study period.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00991432
Start Date
October 1 2009
End Date
March 1 2011
Last Update
February 17 2012
Active Locations (8)
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1
Los Angeles, California, United States, 90049
2
Los Angeles, California, United States, 90095
3
Greenwood Village, Colorado, United States, 80111
4
Sarasota, Florida, United States, 34237