INFUSE BONE GRAFT DENTAL BONE GRAFTING
Infuse™ Bone Graft is a growth factor enhanced bone graft option from Medtronic. Growth factors are a manufactured (genetically engineered) version of a natural protein normally found in small quantities in the body, which regulates bone healing and growth. The natural carrier is made of a material found in bovine tendons. It releases the protein over time where it is placed, provides a scaffold (framework) for new bone to grow into, and is absorbed and replaced by bone over time.
Infuse Bone Graft stimulates the growth of bone-forming cells, manufacturing new bone to replace or heal existing bone. Infuse Bone Graft consists of two parts: a protein that is found in everyone’s body, plus a natural carrier for delivery. RhBMP-2 is the active ingredient in Infuse Bone Graft.
Infuse Bone Graft tells your body to make its own bone:
Using Infuse Bone Graft eliminates the need for a second surgery to “harvest,” or remove surgically, bone from your body (”autogenous” bone) for placement at the oral surgery site. Autogenous bone harvest has the risk of pain, complications, longer surgical time and more anesthesia. For procedures where autogenous bone is not typically used, Infuse Bone Graft can also be used.
Infuse Bone Graft has been proven clinically safe and effective for bone formation. It offers several benefits:
Multiple studies were conducted on approximately 312 patients who did not have enough bone in their upper jaw to place implants. These patients received either Infuse Bone Graft or autogenous bone graft. Infuse Bone Graft grew bone without the need of a bone harvest procedure that is necessary for autogenous bone grafting.
Both the Infuse Bone Graft and autogenous bone graft formed new bone that allowed for the placement of dental implants into patients who otherwise would not have been able to have implants placed. These implants were retained by the majority of patients for two years.
In the sinus lift clinical studies, most patients grew enough bone to place a dental implant regardless of whether they had autogenous bone or Infuse Bone Graft. However, the patients who received autogenous bone graft had a higher success rate of dental implant placement without additional augmentation and a higher rate of significant adverse events, such as limping, pain, and infection.
Complications were reported for both Infuse Bone Graft and autogenous bone graft patients. Patients who received Infuse Bone Graft had fewer complications than those patients who had autogenous bone graft. However, one adverse event, face swelling, was reported more often in the Infuse Bone Graft group.
Please speak with your doctor concerning potential complications associated with your procedure, as well as for more information on these clinical studies.
INFUSE® Bone Graft is indicated as an alternative to autogenous bone graft for sinus augmentations, and for localized alveolar ridge augmentations for defects associated with extraction sockets.
The INFUSE® Bone Graft consists of two components-recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) placed on an absorbable collagen sponge (ACS). These components must be used as a system for the prescribed indication. The bone morphogenetic protein solution component must not be used without the carrier/scaffold component or with a carrier/scaffold component different from the one described in the package insert.
INFUSE® Bone Graft is contraindicated for consumers with a known hypersensitivity to recombinant human Bone Morphogenetic Protein-2, bovine Type I collagen or to other components of the formulation and should not be used in the vicinity of a resected or extant tumor, in consumers with any active malignancy or consumers undergoing treatment for a malignancy, in pregnant women, or consumers with an active infection at the operative site.
There are no adequate and well-controlled studies in human pregnant women. In an experimental rabbit study, rhBMP-2 has been shown to elicit antibodies that are capable of crossing the placenta. Women of childbearing potential should be warned by their surgeon of potential risk to a fetus and informed of other possible dental treatments. The safety and effectiveness of this device has not been established in nursing mothers. Women of childbearing potential should be advised to not become pregnant for one year following treatment with this device.
INFUSE® Bone Graft has not been studied in consumers who are skeletally immature (<18 years of age or no radiographic evidence of epiphyseal closure).
Please see the package insert for the complete list of indications, warnings, precautions, adverse events, clinical results, and other important medical information.
Fiorellini, JP, et al. Randomized Study Evaluating Recombinant Human Bone Morphogenetic Protein-2 for Extraction Socket Augmentation. J Periodontol. 2005 Apr;76(4):605-13.
Triplett RG, et al. Pivotal, Randomized, Parallel Evaluation of Recombinant Human Bone Morphogenetic Protein-2/Absorbable Collagen Sponge and Autogenous Bone Graft for Maxillary Sinus Floor Augmentation. J Oral Maxillofac Surg. 2009 Sep;67(9):1947-60. doi: 10.1016/j.joms.2009.04.085.