An observational study in Alveolar Bone Loss, sponsored by Medtronic Spinal and Biologics. Terminated at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-02-17.
Sponsored by Medtronic Spinal and Biologics · Observational
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.
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.
297 studies on the registry are indexed under Alveolar Bone Loss; 76 are open to participants now.
This study's enrollment of 10 is below the median of 54 across 40 observational studies indexed under Alveolar Bone Loss.
Browse Alveolar Bone Loss studies →Medtronic Spinal and Biologics is the lead sponsor of 56 studies on the registry; 3 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients needing bone augmentation of the alveolar ridge
Exclusion Criteria:
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.
Alveolar ridge bone formation sufficient to place endosseous implants
Time frame: approximately 6 months post-surgery
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
This study is terminated, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Medtronic Spinal and Biologics