Evaluation of Bone Marrow Stem Cells Concentrate with Platelet Rich Fibrin and Bone Graft in Bone Regeneration of Maxillary Cystic Defects Versus Platelet Rich Fibrin with Bone Graft (a Randomized Controlled Trial)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 22
- 主要终点
- cyst volume
研究概览
简要总结
Will the use of bone marrow stem cells with platelet rich fibrin enhance and accelerate the bone regeneration in the upper jaw cystic defects ?
详细描述
Reconstruction of critical size bone defect in maxillofacial surgery is a great challenge, current practice of bone reconstruction still having problems like delay in bone regeneration (up to 12 months) and bone graft failure and low availability of autogenous bone graft.
last decade stem cells therapy gained great interest, in many studies Bone marrow stem cells showed promising result in bone regeneration enhancing .
Platelet Rich Fibrin PRF also capability of enhancing bone and tissue regeneration by releasing of certain protein molecules call growth factors that initiate sequential biological events resulting in stem cells migration into the site of bone defect and differentiation to bone formation cells (osteoblast cells ).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range 18-50 years
- •Patients with a critical size maxillary cyst. (>3 cm)
- •Patients that free of any significant medical conditions that could affect healing or outcomes.
排除标准
- •Patients with large jaw cyst that endanger vital structures
- •Patients with significant medical condition
- •age under 18 years
研究组 & 干预措施
Group B (PRF group)
干预措施: platelet rich fibrin and bone graft (Biological)
Group A (Stem cells ,PRF group) intervention group
干预措施: Bone marrow stem cells concentrate , platelet rich fibrin , bone graft (Biological)
结局指标
主要结局
cyst volume
时间窗: preoperative and 3, 6 months postoperative.
volumetric analysis of cystic defect 3, 6 months after treatment .
次要结局
未报告次要终点
研究者
Motea Abdulsalam Sanad
Principal Investigator
Cairo University