Radiographic Assessment of Three Dimensional Mandibular Position Using Splint-less Patient Specific Implant Following Bilateral Sagittal Split Osteotomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- device feasibility and eligibility for use of PSI
研究概览
简要总结
The purpose of this study was to assess the accuracy of a splint-less approach for mandibular jaw orthognathic surgery. This approach utilized a personalized orthognathic surgical guide (POSG) system, which comprised a set of cutting guides and 3D printed custom titanium fixation plates for bilateral sagittal split osteotomies (BSSOs).
The cutting guides were first used to predrill screw holes and guide osteotomies.
The custom plates were then used to reposition and stabilize the bony segments as planned, without the use of surgical splints or any additional tool such as surgical navigation
详细描述
Surgical technique:
The buccal bony surface of the mandible was exposed as a routine sagittal split osteotomy. First, the mandibular cutting guide was installed using the tooth-borne splint portion of the guide.
Second, the lower portion of the guide was temporarily fixed with titanium screws through the designed screw holes on the guide. The planned margins for vertical osteotomy/ ostectomy were then marked by a pencil.
Once the cutting guide was removed, the sagittal split osteotomy was completed as usual. Finally, the distal and proximal segments were fixed together using the custom plates and screw holes that were used by the cutting guide.
Accuracy of preoperative surgical planning, and validation of the use of patient specific implants (PSI) in bilateral sagittal split osteotomy (BSSO) by comparing the planned outcomes to the actual postoperative outcomes by two methos.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients suffering from skeletal deformity requiring mandibular orthognathic surgery (Bilateral sagittal splitting osteotomy).
- •Patients should be free from any systemic disease that may affect normal bone healing and predictable outcome.
排除标准
- •Patients with metabolic bone disease that affects bone healing.
- •Intra-bony lesions that may affect the osteotomy healing.
- •Patients with history of radiotherapy on the head and neck region
研究组 & 干预措施
single arm study
The purpose of this study was to assess the accuracy of a splint-less approach for mandibular jaw orthognathic surgery. This approach utilized a personalized orthognathic surgical guide (POSG) system, which comprised a set of cutting guides and 3D printed custom titanium fixation plates for bilateral sagittal split osteotomies (BSSOs).
The cutting guides were first used to predrill screw holes and guide osteotomies. The custom plates were then used to reposition and stabilize the bony segments as planned, without the use of surgical splints or any additional tool such as surgical navigation
干预措施: mandibular saggital split osteotomy (Device)
结局指标
主要结局
device feasibility and eligibility for use of PSI
时间窗: 1 week postoperative
The primary outcome of this study is to assess the accuracy of preoperative surgical planning, and validation feasibility of the use of patient specific implants (PSI) in bilateral sagittal split osteotomy (BSSO) by comparing the planned outcomes to the actual postoperative outcomes by two measurement tools (MIMICS software, and DICOM file of pre and post operative CT) . By using software we can superimpose the DICOM files of CT and linear differences in millimetres between fixed points in CT can be obtained to assess the accuracy of the outcome.
次要结局
未报告次要终点
研究者
Abanoub Fayez Aziz
PhD candidate of oral and maxillofacial surgery , principal investigator
Ain Shams University