Sinus Augmentation With Dental Implant

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Maxillary Sinus Bone Loss

Intervention / Treatment
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* Device: INFUSE® Bone Graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to provide written informed consent ≥ 18 years Requires and receives sinus augmentation as part of the scheduled dental implantation into the maxillary alveolar ridge Negative urine pregnancy test for patients of child bearing potential and agreement to not become pregnant for at least 12 months after surgery Able to comply with all study-related procedures, including exercising good oral hygiene A prosthodontic treatment plan has been drafted. Exclusion Criteria: Known hypersensitivity to rhBMP-2, bovine Type I collagen or other components of the formulation Known hypersensitivity to titanium Operative site is in the area of a resected or extant tumor Any active malignancy or current treatment for a malignancy Active infection at operative site History of prior exposure to rhBMP-2/ACS Received and failed a previous sinus augmentation procedure Pathology that would either compromise a bone grafting procedure, or interfere with obtaining quantitative measurements from postoperative computer tomography scans Significant untreated periodontal disease (> Grade 3), caries, or chronic inflammation of the oral cavity at operative site Active use of any nicotine-containing products such as, but not limited to, smoking and chewing tobacco, nicotine patch, nicotine gum, etc. Insulin-dependent diabetic, or has known HgbA1c levels >6.5 % History of malignancy within the past 5 years except for basal cell or squamous cell carcinoma of the skin Patients who are lactating History of metabolic bone disease, excluding idiopathic osteoporosis History of autoimmune disease (e.g., documented multiple allergies, systemic lupus erythematosus, dermatomyositis, etc.) or immunosuppressive disease (e.g, Human Immunodeficiency Virus or Acquired Immune Deficiency Syndrome) History of immune deficiency due to other treatments (e.g., radiation therapy, chemotherapy, steroid therapy) History of adverse reaction to prior exposure to silicone or injectable collagen Treatment with an investigational therapy within 1 month before the surgical procedure or plans to be treated with an investigational therapy during the study period.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| INFUSE® Bone Graft<br>all study participants will receive INFUSE® Bone Graft | Device: INFUSE® Bone Graft<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical stability and osseointegration of endosseous dental implants |  | 6 months post-implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 6 months post-implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Maxillary Sinus Augmentation, Dental Implantation, Osseointegration, Bone Morphogenetic Proteins