NCT06188403已完成不适用
Comparison of Radiographic Accuracy Between Pre-bent Titanium Plates and 3D Customized Titanium Plates After le Fort 1 Osteotomy in Orthognathic Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 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
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
研究者
研究点 (2)
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