Status:
TERMINATED
Sinus Augmentation With Dental Implant
Lead Sponsor:
Medtronic Spinal and Biologics
Collaborating Sponsors:
Averion International Corporation
Conditions:
Maxillary Sinus Bone Loss
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this research study is to shorten the treatment time course for patients who are scheduled for surgery to have a sinus lift and dental implant(s) placed into the upper front part of the...
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
- Requires and receives sinus augmentation as part of the scheduled dental implantation into the maxillary alveolar ridge
- Negative urine pregnancy test for patients of child bearing potential and agreement to not 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 sinus 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 3), 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 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 Immune Deficiency 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 :
January 1 2011
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00991393
Start Date
October 1 2009
End Date
January 1 2011
Last Update
February 17 2012
Active Locations (5)
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1
Fullerton, California, United States, 92835
2
Denver, North Carolina, United States, 28037
3
Philadelphia, Pennsylvania, United States, 19104
4
Dallas, Texas, United States, 75246