Localized Alveolar Ridge Augmentation With Space Maintenance Devices

Stopped early

Conditions studied: Alveolar Bone Loss

In brief

The purpose of this research study is to determine whether this study treatment can improve the bone structure of the upper front part of the jaw in patients who are scheduled for surgery to have a dental implant(s) placed into the upper front part of their mouths and need to have more bone in their jaws to support the implant, so that a dental implant can later be inserted.

Key facts

Study ID

NCT00991432

Run by

Medtronic Spinal and Biologics

People needed

10

Starts

2009-10-01

Expected to finish

2011-03-01

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
• Scheduled for dental implant into anterior maxillary alveolar ridge
• Negative urine pregnancy test for patients of child bearing potential and agreement not to 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 alveolar ridge 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 III), 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 glycated hemoglobin (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 immunodeficiency 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 — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Greenwood Village, Colorado, United States
• Study site — Sarasota, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Lafayette, Indiana, United States
• Study site — Denver, North Carolina, United States
• Study site — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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