Comparison of Radiographic Accuracy Between Pre-bent Titanium Plates and 3D Customized Titanium Plates 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 accuracy between postoperative plan and postoperative result.
研究概览
简要总结
patients with dentofacial deformities , who needs lefort 1 osteotomy to correct position of maxilla , are divided into two groups: one group receives custom titanium plates which is patient specific and the other group receives prebent titanium plates done on printed postop plan model before surgery.
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
- •. Patients with non-syndromic dentofacial deformity requiring Le Fort I with or without bimaxillary osteotomy.
排除标准
- •Patients with acute infection at 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
(group one) will be treated with custom titanium plates and guide to reposition the maxilla
7 patients are included in this arm. Le Fort I osteotomy using CAD CAM surgical guide and 3Dcustomized plate are placed to reposition the maxilla according to the virtual surgical planning.
干预措施: Orthognathic surgery (lefort1) (Procedure)
(group 2) will be treated with prebent titanium plates
7 patients are included in this arm. le fort 1 osteotomy using surgical guide and pre-bent stock titanium plates are used after their adaptation on the model of postoperative plan.
干预措施: Orthognathic surgery (lefort1) (Procedure)
结局指标
主要结局
Radiographic accuracy between postoperative plan and postoperative result.
时间窗: one month
Cone Beam Computed tomography (CBCT) is used at 1 month to assess surgical outcome by comparing the clinical results with the virtually planned outcome.
次要结局
未报告次要终点