The Evaluation of the Effect of Performing Guided Lid Surgery With Enucleation of Cystic Lesions Compared to Conventional Cystic Enucleation; a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Regain of bone volume
研究概览
简要总结
to evaluate the percentage of bone volume regain along with postoperative pain in cases done using the bone lid technique in comparison with those done using the conventional cyst enucleation technique.
详细描述
The study will involve eighteen patients selected from the outpatient clinic, Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Ain Shams University.
The patients included in this study will be informed about the full details of this research and they will sign an informed consent. Moreover, this research will be reviewed by the research ethics committee, Faculty of Dentistry, Ain Shams University.
Randomization:
The study consists of two groups each containing 10 patients. Patients will be randomly allocated according to predetermined computer-generated randomization using (www.randomizer.org).
PICO:
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)
盲法说明
Double blinded
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ranging from 18-60 years.
- •Have free medical history or controlled systemic disease.
- •Expansile cystic lesion with intact cortical bone extending from 2-6 teeth.
- •A minimum thickness of 1 mm of the cortical bone.
排除标准
- •Patients with history of surgery in the area affected by the cystic lesion.
- •Patients with suspected malignant tumors in the area.
结局指标
主要结局
Regain of bone volume
时间窗: 6 months
evaluation of formed bone using CBCT
次要结局
- Pain with visual analogue scale(one week)
研究者
Yasser Mohamed Nabil Ahmed Khirat El Hadidi
principle investigator
Ain Shams University