Randomized Controlled Clinical Trial to Assess the Efficacy of a Combination of Autologous Mesenchymal Stem Cells and Biomaterial in Jaw Bone Regeneration Prior to Dental Implant Placement in Comparison to Standard Autologous Bone Grafting
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 6
- 主要终点
- Change in bone width
研究概览
简要总结
A randomized controlled clinical multi center trial to assess the efficacy of a combination of autologous mesenchymal stem cells and biomaterial in jaw bone regeneration prior to dental implant placement in comparison to standard autologous bone block grafting.
详细描述
A phase III multi center clinical trial, randomized and controlled.The study subject is lacking one or more sheet behind the canine in the upper or lower jaw, and the alveolar ridge is too narrow to place a dental implant. The test objects will have augmentation using autologous mesenchymal stromal cells and a biomaterial, biphasic Calcium Phosphate. The control is the traditional bone block from the ramus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, non smoking patients in need of dental implants in the upper or lower jaw, with loss in vertical height and less that 4 mm in lateral width.
排除标准
- •General contraindications for dental and/or surgical treatments
- •Contraindications for both bone marrow harvesting and bone grafts
- •History of any malignant diseases
- •Concurrent or previous radiotherapy of head and neck region
- •History of contagious diseases (HIV, HTLV and/or syphilis seropositivity, hepatitis B or C infection)
- •Uncontrolled diabetes mellitis, e.g. patients with diabetes not regulated with medications or diet. This will be verified based on patient's history and concurrent HbA1c levels (HbA1c > 53 mmol/mol).
- •Inflammatory and autoimmune disease of the oral cavity.
- •Concurrent or previous immunosuppressant, bisphosphonate or high dose corticosteroid therapy.
研究组 & 干预措施
Test
Expanded, autologous mesenchymal stem cells in combination with biphasic calcium phosphate
干预措施: Advanced medicinal Therapy (MSC combined with biomaterial) (Combination Product)
Control
The gold standard; Bone block from the ramus of the nation will be transplanted to the alveolar ridge.
干预措施: Autologous bone graft (Procedure)
结局指标
主要结局
Change in bone width
时间窗: 0-5 months
Changes in linear measurements of bone width measured by CBCT.Principal assessment is linear change in bone width 2 mm below alveolar crest measured by means of CBCT images from baseline to 5 months after the regenerative surgery, immediately prior to implant placement
次要结局
- Radiological examination of bone volume(21 months)
- Pain postoperatively in the two different treatments(21 months)