The purpose of this research study is to shorten the treatment time course for 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.
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 shorten the treatment time course for the patients. This post-market study has been designed to further evaluate the effectiveness and safety of INFUSE® Bone Graft, along with dental implant placement, in a single procedure.
Observational Model: Cohort, Time Perspective: Prospective
Alveolar Bone Loss
INFUSE® Bone Graft
Loma Linda
California
United States
92350
Recruiting
Medtronic Spinal and Biologics
Published on BioPortfolio: 2014-07-23T21:12:32-0400
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Alveolar bone is critical in supporting natural teeth, dental implants as well as a removable and fixed prosthesis. Alveolar bone volume diminishes when its associated natural tooth is lost.
Alveolar Bone Loss
Resorption or wasting of the tooth-supporting bone (ALVEOLAR PROCESS) in the MAXILLA or MANDIBLE.
Alveolar Bone Grafting
Surgical procedure to add bone to the ALVEOLAR RIDGE in children born with a CLEFT LIP and a CLEFT PALATE.
Carpal Bones
The eight bones of the wrist: SCAPHOID BONE; LUNATE BONE; TRIQUETRUM BONE; PISIFORM BONE; TRAPEZIUM BONE; TRAPEZOID BONE; CAPITATE BONE; and HAMATE BONE.
Bone-patellar Tendon-bone Grafts
A bone-patellar tendon graft used for fixation of the ANTERIOR CRUCIATE LIGAMENT during surgical reconstruction of the knee.
Bone-patellar Tendon-bone Graft
Fixation of the ANTERIOR CRUCIATE LIGAMENT, during surgical reconstruction, by the use of a bone- patellar tendon autograft.