Localized Alveolar Ridge Augmentation With Space Maintenance Devices (Ridge Mesh)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||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|
- Alveolar ridge bone formation sufficient to place endosseous implants [ Time Frame: approximately 6 months post-surgery ] [ Designated as safety issue: No ]
- Evidence of successful INFUSE® Bone Graft placement, an increase in the alveolar ridge width and the safety of INFUSE® as assessed by CT scans. [ Time Frame: approximately 6 months post-surgery ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2009|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
INFUSE® Bone Graft
all study participants will receive INFUSE® Bone Graft
Device: INFUSE® Bone Graft
Patients will be treated with the commercially available INFUSE® Bone Graft material applied to an ACS concurrent with space maintenance devices for soft tissue management on Day 0 (Surgery). A follow-up visit will take place 2 weeks after implant of the INFUSE® 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 approximately 6 months after surgery. Between the follow-up visit and the EOS visit, patients will be seen as per the SOC schedule for the facility.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00991432
|United States, California|
|Los Angeles, California, United States, 90049|
|Los Angeles, California, United States, 90095|
|United States, Colorado|
|Greenwood Village, Colorado, United States, 80111|
|United States, Florida|
|Sarasota, Florida, United States, 34237|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|United States, Indiana|
|Lafayette, Indiana, United States, 47904|
|United States, North Carolina|
|Denver, North Carolina, United States, 28037|
|United States, Oregon|
|Portland, Oregon, United States, 97221|