The Effect of Bone Marrow Aspirate Concentrate in the Treatment of Mandibular Cystic Defects (Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in pain scores
研究概览
简要总结
Mandibular cystic defect healing is a complex process. Various methods have been developed to shorten the bone regeneration time and improve its quality. Autogenous grafting is the gold standard for filling cystic defects due to the osteogenesis property provided by the viable cells but is related to donor site morbidity. Allografts and Xenografts are used for the same purpose. However, the increased cost is their main disadvantage. Bone marrow aspirate concentrate is now used to enhance the healing and regeneration process in many areas of the body with no morbidity and low cost.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from mandibular cystic defect.
- •Cystic defect width of 4-8 cm that requires removal under general anesthesia.
排除标准
- •Medically compromised patients contradicting operation.
- •Previously enucleated lesions.
- •Previous surgery, tumor, infection to the pelvis affecting the anterior iliac crest.
- •Infected Cysts
研究组 & 干预措施
Control group
干预措施: Conventional enucleation only (Other)
Test group
干预措施: Enucleation and filling by Bone marrow aspirate (Other)
结局指标
主要结局
Change in pain scores
时间窗: 1st day, 1 week, 4 weeks, 6 weeks
pain was assessed through a 10-point Visual Analogue Scale (VAS) the scores are categorizied as follows: (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)
Change in bone density
时间窗: at baseline, 3 months, 6 months
An immediate postoperative CBCT was be obtained, followed by another one taken after 3 and 6 months postoperatively. The Region of Interest (ROI) feature was used to estimate the mean bone density in the immediate and 6 months scans. The mean bone density in the 6 months CBCT-scan was compared with the immediate postoperative and the preoperative scans and the mean difference between the scans was calculated.
次要结局
- change in wound dehiscence(1st day, 1 week, 4 weeks, 6 weeks)
研究者
Hams Hamed Abdelrahman
Assistant lecturer of DPH and Clinical statistician
Alexandria University