Accuracy of Maxillary Fixation Using Custom Plates on Nasal Buttress Only Via Minimally Invasive Approach Versus Custom Plates on Nasal and Zygomatic Buttresses Via Conventional Approach in Orthognathic Surgeries: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Accuracy of the maxilla fixation on CT compared to preoperative plan assessed by superimposition of preoperative and immediate postoperative scans.
研究概览
简要总结
The goal of this clinical trial is to evaluate of the accuracy maxilla fixation using custom plates on nasal buttress only via minimally invasive approach versus using custom plates on nasal and zygomatic buttresses via conventional approach. The main question it aims to answer is:
• Is the minimally invasive approach accurate and stable ? Researchers will compare minimally invasive technique to the traditional technique of fixation of the maxilla bone to see if it is as accurate and stable.
Participants will:
- Undergo surgey
- Follow up visits weekly for a month then on a monthly basis for 5 more months.
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
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with dentofacial disharmony and misalignment requiring bimaxillary orthognathic surgeries.
- •Patients with no signs or symptoms of active TMDs.
- •Highly motivated patients.
排除标准
- •Patients who refused to be included in the research.
- •Patients with systemic diseases that may hinder the normal healing process or render the patient not fitting for general anaesthesia.
- •Patients with intra-bony lesions or infections that may retard the osteotomy healing.
结局指标
主要结局
Accuracy of the maxilla fixation on CT compared to preoperative plan assessed by superimposition of preoperative and immediate postoperative scans.
时间窗: from preoperative plan to immediate postoperative (1 week)
linear measurement of discrepancy between both scans after superimposition
次要结局
- Stability of maxilla fixation by superimposing preoperative and 6months postoperative CT scans(from enrollment to 6 month postoperative)
研究者
Mahmoud Hamid Khorshed
oral & maxillofacial surgeon
Cairo University