An Open Label, Non-randomized, Single-arm, Multi-center Study to Assess Localized Alveolar Ridge Augmentation Utilizing INFUSE® Bone Graft Concurrent With Space Maintenance Devices for Soft Tissue Management
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 主要终点
- Alveolar ridge bone formation sufficient to place endosseous implants
研究概览
简要总结
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.
详细描述
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 determine whether this study treatment can improve the bone structure of the upper front part of the jaw so that a dental implant can later be inserted. This post-market study has been designed to further evaluate the effectiveness and safety of INFUSE® Bone Graft, along with space holding devices, in a 2-part procedure. Your dental implants will be placed at approximately 6 months after the INFUSE® Bone Graft implant.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide written informed consent
- •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.
排除标准
- •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.
结局指标
主要结局
Alveolar ridge bone formation sufficient to place endosseous implants
时间窗: approximately 6 months post-surgery
次要结局
- Evidence of successful INFUSE® Bone Graft placement, an increase in the alveolar ridge width and the safety of INFUSE® as assessed by CT scans.(approximately 6 months post-surgery)