An Open Label, Non-randomized, Single-arm, Multi-center Study to Assess Localized Alveolar Ridge Augmentation Utilizing INFUSE® Bone Graft Concurrent With Space Maintenance Devices for Soft Tissue Management
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Alveolar Bone Loss
- Sponsor
- Medtronic Spinal and Biologics
- Enrollment
- 10
- Primary Endpoint
- Alveolar ridge bone formation sufficient to place endosseous implants
- Status
- Terminated
- Last Updated
- 14 years ago
Overview
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 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, so that a dental implant can later be inserted.
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 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 determine whether this study treatment can improve the bone structure of the upper front part of the jaw so that a dental implant can later be inserted. This post-market study has been designed to further evaluate the effectiveness and safety of INFUSE® Bone Graft, along with space holding devices, in a 2-part procedure. Your dental implants will be placed at approximately 6 months after the INFUSE® Bone Graft implant.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Able to provide written informed consent
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Alveolar ridge bone formation sufficient to place endosseous implants
Time Frame: approximately 6 months post-surgery
Secondary Outcomes
- Evidence of successful INFUSE® Bone Graft placement, an increase in the alveolar ridge width and the safety of INFUSE® as assessed by CT scans.(approximately 6 months post-surgery)