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. Identifier: NCT00991393
Recruitment Status : Terminated
First Posted : October 8, 2009
Last Update Posted : February 17, 2012
Averion International Corporation
Information provided by (Responsible Party):
Medtronic Spinal and Biologics

Brief Summary:
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.

Condition or disease Intervention/treatment
Maxillary Sinus Bone Loss Device: INFUSE® Bone Graft

Detailed Description:

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
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
Study Start Date : October 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  1. Clinical stability and osseointegration of endosseous dental implants [ Time Frame: 6 months post-implantation ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients needing sinus augmentation (sinus lift) concurrent with placement of dental implants

Inclusion Criteria:

  1. Able to provide written informed consent
  2. ≥ 18 years
  3. Requires and receives sinus augmentation as part of the scheduled dental implantation into the maxillary alveolar ridge
  4. Negative urine pregnancy test for patients of child bearing potential and agreement to not become pregnant for at least 12 months after surgery
  5. Able to comply with all study-related procedures, including exercising good oral hygiene
  6. A prosthodontic treatment plan has been drafted.

Exclusion Criteria:

  1. Known hypersensitivity to rhBMP-2, bovine Type I collagen or other components of the formulation
  2. Known hypersensitivity to titanium
  3. Operative site is in the area of a resected or extant tumor
  4. Any active malignancy or current treatment for a malignancy
  5. Active infection at operative site
  6. History of prior exposure to rhBMP-2/ACS
  7. Received and failed a previous sinus augmentation procedure
  8. Pathology that would either compromise a bone grafting procedure, or interfere with obtaining quantitative measurements from postoperative computer tomography scans
  9. Significant untreated periodontal disease (> Grade 3), caries, or chronic inflammation of the oral cavity at operative site
  10. Active use of any nicotine-containing products such as, but not limited to, smoking and chewing tobacco, nicotine patch, nicotine gum, etc.
  11. Insulin-dependent diabetic, or has known HgbA1c levels >6.5 %
  12. History of malignancy within the past 5 years except for basal cell or squamous cell carcinoma of the skin
  13. Patients who are lactating
  14. History of metabolic bone disease, excluding idiopathic osteoporosis
  15. 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)
  16. History of immune deficiency due to other treatments (e.g., radiation therapy, chemotherapy, steroid therapy)
  17. History of adverse reaction to prior exposure to silicone or injectable collagen
  18. 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.

Information from the National Library of Medicine

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 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
Sponsors and Collaborators
Medtronic Spinal and Biologics
Averion International Corporation

Responsible Party: Medtronic Spinal and Biologics Identifier: NCT00991393     History of Changes
Other Study ID Numbers: P09-05
First Posted: October 8, 2009    Key Record Dates
Last Update Posted: February 17, 2012
Last Verified: October 2011

Keywords provided by Medtronic Spinal and Biologics:
Maxillary Sinus Augmentation
Dental Implantation
Bone Morphogenetic Proteins