Clinical trial NCT00991393: Sinus Augmentation With Dental Implant
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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Maxillary Sinus Bone Loss
Keywords: Maxillary Sinus Augmentation
Dental Implantation
Osseointegration
Bone Morphogenetic Proteins
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
Collaborators: name: Averion International Corporation
First posted: 2009-10-08
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients needing sinus augmentation (sinus lift) concurrent with placement of dental implants

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical stability and osseointegration of endosseous dental implants
timeFrame: 6 months post-implantation
Secondary outcomes:
measure: 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.
timeFrame: 6 months post-implantation
Other outcomes:
Locations:
city: Fullerton
country: United States
state: California
city: Denver
country: United States
state: North Carolina
city: Philadelphia
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
Study officials:
References: