Three-dimensional Volumetric Analysis of Bone Regeneration Following Jaw Cysts Enucleation With and Without Autologous Albumin Gel-platelet-rich Fibrin Mixture (A Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in soft tissue healing
研究概览
简要总结
Cyst is the main cause for longstanding swelling in the mandible or the maxilla, its enlargement usually results in resorption and weakening of bone. Thus the treatment of the cysts is essential to preserve the bone and the adjacent vital structures. Healing of the bone defect and its surrounding soft tissues is a critical issue that needs concerns. Although the Platelet rich fibrin has promising effects in wound healing, it can resorb during 10-14 days. Thus a new autologous platelet concentrate is introduced by Kawasi et al that can remain stable for 4-6 months called albumin PRF.
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
- 否
入选标准
- •Patients suffering from jaw cystic cavity volume greater than 1cm3
- •Patients with no gender predilection that agreed to present for follow-up visits for a minimum postoperative period of 6 months.
- •Cystic lesion that requires removal under local or general anaesthesia.
排除标准
- •Medically compromised patients contradicting operation.
- •Patients with history of chemotherapy or radiotherapy.
- •Patients with low level of platelet count.
- •Patients with anticoagulant therapy.
- •Patients who are unable to attend follow up appointments
结局指标
主要结局
Change in soft tissue healing
时间窗: up to 2 weeks
it will be used using Landry index Healing Index 1: Very poor (has two or more of the following) Healing Index 2: Poor Healing Index 3: Good Healing Index 4: Very good Healing Index 5: Excellent
change in bone volume
时间窗: at baseline and 6 months
it will be assessed using CBCT
Change in pain score
时间窗: Up to 1 week
It will be assessed on 3rd and 7th day through a 10-point Visual Analogue Scale (VAS)(25) (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)
次要结局
未报告次要终点
研究者
Hams Hamed Abdelrahman
Assistant lecturer of DPH and Clinical statistician
Alexandria University