Sinus Augmentation With Dental Implant (SinusDI)
The purpose of this research study is to shorten the treatment time course for patients who are scheduled for surgery to have a sinus lift and dental implant(s) placed into the upper front part of their mouth, and need to have more bone in their jaws and a thicker sinus floor to support the implant.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||An Open Label, Non Randomized, Single Arm, Multi Center Study to Assess Sinus Augmentation (Sinus Lift) Utilizing INFUSE® Bone Graft Concurrent With Dental Implant Placement|
- Clinical stability and osseointegration of endosseous dental implants [ Time Frame: 6 months post-implantation ] [ Designated as safety issue: No ]
- Evidence of successful INFUSE® Bone Graft placement, as well as the safety of INFUSE® when used in sinus augmentation which will be confirmed by CT scans. [ Time Frame: 6 months post-implantation ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2009|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 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 in the area of the dental implant 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 the standard of care (SOC) for the facility. Patients will return to the facility for final End of Study (EOS) assessments 6 months after surgery for placement of the appropriate prosthetic, and assessment of osseointegration and stability. 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 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 and a sinus lift, in a single procedure.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00991393
|United States, California|
|Fullerton, California, United States, 92835|
|United States, North Carolina|
|Denver, North Carolina, United States, 28037|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Texas|
|Dallas, Texas, United States, 75246|
|Houston, Texas, United States, 77063|