Accuracy of Maxillary Two Customized 3D Titanium Miniplates Versus Four Customized 3D Miniplates for Virtual Plan Transfer in Orthognathic Surgery. Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- assessment of the accuracy of plan transfer
研究概览
简要总结
In this research the investigators aim to minimize the use of more hardware in the fixation of the orthognathic surgery cases. The objective of this study is to assess the accuracy of the plan transfer with two customized titanium plates versus four customized titanium plates.
详细描述
In orthognathic surgery cases, maxillary repositioning in three dimensions can be obtained. Recently using the custom-made plates instead of wafer used in classic models can get an accurate plan transfer, however it can get suboptimal accurate repositioning.
The aim of the study is to evaluate the accuracy of two customized titanium plates versus four customized titanium plates in transferring the virtual plan in orthognathic surgeries.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •.Patients with dentofacial disharmony and misalignment requiring 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 anesthesia.
- •Patients with intra-bony lesions or infections that may retard the osteotomy healing.
研究组 & 干预措施
two customized titanium plates for virtual plan transfer in orthognathic surgery
two customized titanium plates for virtual plan transfer in orthognathic surgery for accurate plan transfer to the surgical field
干预措施: two customized titanium plates (Procedure)
four customized titanium plates for virtual plan transfer in orthognathic surgery
four customized titanium plates for virtual plan transfer in orthognathic surgery for accurate plan transfer to the surgical field
干预措施: four customized titanium plates (Procedure)
结局指标
主要结局
assessment of the accuracy of plan transfer
时间窗: within one week
Specific measurement variable: 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 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.
次要结局
- patient satisfaction(6 months)
研究者
mohamed gamal hammad
principal investigator
Cairo University