Comparison of Accuracy Between Novel Locating Guide Design With Pre-bent Titanium Plates and 3d Printed Intermediate Wafer to Reposition the Maxilla After le Fort 1 Osteotomy in Orthognathic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Radiographic evaluation of accuracy by superimposition
研究概览
简要总结
clinical and radiographic comparison between novel locating guide design with pre-bent titanium plates and 3d printed intermediate wafer to reposition the maxilla after Le Fort 1 osteotomy in orthognathic surgery (randomized controlled clinical trial)
详细描述
Eligible patients will be allocated randomly into 2 equal groups with 7 patients in each group according to the method that will be used to reposition the maxilla by simple randomization using computer generated random numbers. Group 1 (Study group) will be treated with locating guides to reposition the maxilla with pre-bent plates on 3d model. Group 2 (Control group) will be treated with Intermediate wafer.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients requiring Le Fort I osteotomy will be selected including those suffering from skeletal malocclusion (Class II or Class III), midface hypoplasia or vertical maxillary excess.
排除标准
- •cleft lip and palate. skeletal disharmony due to trauma or severe facial asymmetry. significant medical condition.
研究组 & 干预措施
(Study group) will be treated with locating guides to reposition the maxilla with pre-bent plates
After le fort 1 osteotomy, locating guides will be used to reposition the maxilla with pre-bent plates.
干预措施: Orthognathic surgery (lefort1) (Procedure)
(Control group) will be treated with Intermediate wafer.
After le fort 1 osteotomy, Intermediate wafer will be used with intermaxillary fixation.
干预措施: Orthognathic surgery (lefort1) (Procedure)
结局指标
主要结局
Radiographic evaluation of accuracy by superimposition
时间窗: 2 weeks
Postoperative CBCT was obtained after 2 weeks of surgery for comparison with the expected position of the maxilla in the preoperative virtual plan using 3-matic software in Mimics innovation suite software package. The preoperative planned final maxillary position was compared with the actual postoperative maxillary position by superimposing both STL models on each other with anatomical points along the orbital rims and the zygomatic arch used as reference points for alignment. The N points registration tool was used to obtain the alignment. Afterwards, using trim tool all parts were trimmed except that between the plates and the maxillary teeth crowns. Then the part comparison analysis tool was used to calculate the accuracy of the superimposition of the maxillary segment using point-based analysis algorithm after 2 weeks of surgery for comparison with the expected position of the maxilla in the preoperative virtual plan using Mimics innovation suite software.
The surgery duration
时间窗: 1 week
The time taken between performing the Le fort 1 osteotomy till completion of plate fixation will be measured.
次要结局
- Postoperative Pain(after one week, two weeks)