Evaluating the Accuracy of Soft Tissue Prediction in Patients With Mandibular Prognathism After Orthognathic Surgery Using Handheld Scanner Versus Optical Scanner A Prospective Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- soft tissue prediction accurace
研究概览
简要总结
Aim of study: To evaluate the accuracy of soft tissue prediction in orthognathic surgery using handheld scanners versus optical scanners.
Research hypothesis (null hypothesis): there is no difference in prediction accuracy between laser scans and handheld scans.
Primary objective: To evaluate The Accuracy of soft tissue prediction in orthognathic surgery using handheld scanner versus laser scanner
.
Secondary objective:
To evaluate scanning time, cost efficiency, and ease of use. patients will be treated from mandibular prognathism using only mandibular set back or bimaxillary surgery After six months postoperatively, 3D facial scans is obtained and exported to software to perform superimposition of the predicted and post operative results to assess the accuracy of soft tissue prediction By measuring the difference in millimeter between prespecified points
详细描述
Aim of study: To evaluate The Accuracy of soft tissue prediction in orthognathic surgery using handheld scanner versus optical scanner.
Research hypothesis (null hypothesis) that there is no difference in prediction accuracy between laser scans and handheld scans.
Primary objective: To evaluate The Accuracy of soft tissue prediction in orthognathic surgery using handheld scanner versus laser scanner .
Secondary objective:
To evaluate scanning time, cost efficiency, ease of use. 8. Trial design
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patients with facial mandibular prognathism that requires orthognathic surgery.
- •Age (18- 50 years).
- •Patients are willing for the surgical procedure and follow-up, with informed consent
排除标准
- •• Dental malocclusion that could be treated with orthodontic treatment only.
- •Patients with contraindications for general anesthesia.
- •Patient on radiotherapy.
- •Patients suffer from bone disease
结局指标
主要结局
soft tissue prediction accurace
时间窗: six months after surgery
3d facial scans is obtained and exported to software to perform superimposition of the predicted and post operative results to assess the accuracy of soft tissue prediction By measuring the difference in millimeter between prespecified points 1-full face 2-subnasal 3-labrale superioris 4- labrale inferioris 5-pogonion 6- corners of the mouth Then the degree of accuracy will be measured in percentage
次要结局
未报告次要终点
研究者
Ahmed Elsayed Fahim
PhD candidate
Cairo University