Sinus Augmentation With Dental Implant

Stopped early

Conditions studied: Maxillary Sinus Bone Loss

In brief

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.

Key facts

Study ID

NCT00991393

Run by

Medtronic Spinal and Biologics

People needed

23

Starts

2009-10-01

Expected to finish

2011-01-01

Last updated by the study team

2012-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Fullerton, California, United States
• Study site — Denver, North Carolina, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.