Accuracy of Patient Specific 3D Printed Titanium Plates Versus 3D Milled Titanium Plates in Genioplasty Orthognathic Surgeries. A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 26
- 主要终点
- Accuracy of manufacturing of the patient specific 3D printed titanium plates versus milled titanium plates in genioplasty
研究概览
简要总结
To assess accuracy of patient specific 3D printed titanium plates versus 3D milled titanium plates in genioplasty orthognathic surgery
详细描述
the first treatment include treating patients with 3D printed titanium plates while the second treatment include treating patients with 3D milled titanium plates in genioplasty orthognathic surgery and assess the accuracy between the two treatments
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with dentofacial disharmony and misalignment requiring bimaxillary orthognathic surgeries.
- •Patients with no signs or symptoms of active TMDs.
- •Highly motivated patients.
排除标准
- •Patients who refused to be included in the research.
- •Patients with systemic diseases that may hinder the normal healing process or render the patient not fitting for general anaesthesia.
- •Patients with intra-bony lesions or infections that may retard the osteotomy healing.
- •Patients with systemic condition contraindicating with the surgical procedure as uncontrolled diabetes
结局指标
主要结局
Accuracy of manufacturing of the patient specific 3D printed titanium plates versus milled titanium plates in genioplasty
时间窗: immediately postoperative
Accuracy of manufacturing of the patient specific customized 3D printed titanium plates in the study group versus milled titanium plates in the control group in genioplasty measure The skull base in the virtual surgical plan was superimposed using point-based matching ICP registration using anatomical reference points, followed by manual surface-based registration to surface best fit with the skull base in the actual post-operative CBCT scans. the measurement tool is CBCT scans superimposition in mm
次要结局
- stability of manufacturing of the patient specific 3D printed titanium plates versus milled titanium plates in genioplasty(6 months postoperative)
研究者
Mina ElHadidi Sobhi Ramzi Michael
Principal Investigator
Cairo University