Assessment Of Computer-Aided Design/Manufacturing for Le Fort I Osteotomy and 3D-customized Titanium Plate in Orthognathic Surgery (Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in pain
研究概览
简要总结
Background: In orthognathic surgery, virtual planning is gradually taking over in clinical practice. To start with, virtual surgery planning (VSP) is believed to be less time-consuming and less expensive than conventional surgery planning (CSP). Moreover, the improved visualization of craniofacial deformities, such as occlusal canting and asymmetries, is a further advantage. Aim: To assess the result of Le Fort I osteotomy using CAD/CAM and 3Dcustomized titanium plate with virtual planning in orthognathic surgery. Materials and Methods: 8 patients with vertical maxillary excess will be included in the study. Le Fort I osteotomy using CAD CAM surgical guide and 3Dcustomized plate will be done for the study group. All patients will be followed clinically and radiographically for one month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with non-syndromic dentofacial deformity requiring isolated Le Fort I with or without bimaxillary osteotomy.
- •Patients with good oral hygiene.
- •Class II or III malocclusion.
- •Patients who were scheduled to undergo a CT scan as a part of their diagnosis and treatment
排除标准
- •Patients with acute infection at the surgery site.
- •Patient with Systemic disorders contraindicating surgery.
- •Alcohol or drug abuse is prohibited.
- •patients who suffered from craniofacial syndrome;
- •patients who had previous orthognathic surgery;
- •patients who had previous maxillary or mandibular trauma
研究组 & 干预措施
Le Fort I osteotomy
干预措施: Le Fort I osteotomy using CAD CAM surgical guide and 3Dcustomized plate (Procedure)
结局指标
主要结局
Change in pain
时间窗: 2nd and 7th days
pain will be scored using visual analogue scale. it ranges from 0 to 10, 0 mean no pain and 10 means severe pain
Change in post operative osteotomy position
时间窗: Immediate post operative
Computed tomography (CT) will be used immediately postoperative to assess surgical position by comparing the clinical results with the virtually planned outcome.
change in edema
时间窗: 2nd and 7th days
it was evaluated by its ability to pit. The examiner's fingers will press into the dependent area for 5 seconds, and the pitting will be graded on a scale of +1 to+4.
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