Transplantation of Bone Marrow Mesenchymal Stromal Cells for Bone Regeneration in Periodontal Disease
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in probing pocket depth (PPD)
研究概览
简要总结
The goal of this study is to evaluate the capacity of allogeneic bone marrow mesenchymal stromal cells (MSC) to induce bone regeneration in patients with periodontal disease. MSC cultured are loaded on a collagen scaffold, included into autologous platelet rich plasma clot and implanted in the bone defect.
详细描述
The clinical protocol is designed to evaluate the bone regeneration capacity of allogeneic MSCs for the treatment of patients with chronic or aggressive periodontal disease. Patients with either a 2- or 3-wall intrabony defects are included in this study. A bioengineering construct, constituted by allogeneic MSCs and a collagen scaffold, is incorporated into platelet rich plasma (PRP) clot, which is implanted at the bone defect site. Follow up of treated tooth are assessed by clinical evaluation, intraoral radiography and cone-beam CT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medical healthy
- •Minimum age of 18 years old
- •Diagnosis of chronic or aggressive periodontitis
- •Vertical intrabony defects of three or two walls
- •PPD >= 5 mm
- •Radiographic evidence of alveolar bone loss of at least 3 mm
- •Minimim 20 teeth presents in mouth.
- •Informed consent of the patient
排除标准
- •Pregnancy or lactating
- •Receiving immunosuppressive drugs, anticoagulants, antibiotics or analgesic drugs
- •Diabetics
研究组 & 干预措施
Allogeneic MSCs transplantation in periodontal disease
Allogeneic MSC harvested and cultured in osteogenic medium are seeded on collagen scaffold, mixed with autologous platelet rich plasma clot. The MSCs construct (MSCs/Coll/PRP clot) is implanted in the bone defect.
干预措施: Transplantation of allogeneic MSCs in periodontal disease (Biological)
结局指标
主要结局
Change in probing pocket depth (PPD)
时间窗: Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation
The distance from the gingival margin to the bottom of the gingival sulcus/pocket, is measured by means of periodontal probe.
Change in clinical attachment level (CAL)
时间窗: Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation
Expressed as the distance in millimeters from the cemento-enamel junction (CEJ) to the bottom of the probable gingival/periodontal pocket.
Change in bone density
时间窗: Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation
Changes in the density of the periodontal bone defect will be detected by Cone beam Tomography
Change in Tooth Mobility (TM)
时间窗: Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation
Changes from baseline in tooth mobility will be recorded.
Gingival recession (GR)
时间窗: Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation
Exposure of the tooth through apical migration of the gingiva will be recorded as the distance in millimeters from the CEJ to the gingival margin
Change in bone depth
时间窗: Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation
The vertical bone defects will be assessed by X-rays. The postoperative depth of the intrabony defect will be calculated from the distance between the cemento-enamel junction and the bone crest on the preoperative and postoperative radiographs at the same magnification.
次要结局
未报告次要终点
研究者
Dylana Diaz Solano
Clinical Investigator
Instituto Venezolano de Investigaciones Cientificas