Sinus Augmentation With Dental Implant (SinusDI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00991393|
Recruitment Status : Terminated
First Posted : October 8, 2009
Last Update Posted : February 17, 2012
|Condition or disease||Intervention/treatment|
|Maxillary Sinus Bone Loss||Device: INFUSE® Bone Graft|
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.
|Study Type :||Observational|
|Actual Enrollment :||23 participants|
|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|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
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.
- Clinical stability and osseointegration of endosseous dental implants [ Time Frame: 6 months post-implantation ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|