A Randomized Controlled Trial of the Accuracy of Maxillary Repositioning Using Personalized Titanium Plates vs CAD/CAM Surgical Splints in Orthognathic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Difference of the maxillary position
研究概览
简要总结
The purpose of this study is to determine whether personalized titanium plates can achieve better accuracy than CAD/CAM surgical splint in maxilla repositioning in orthognathic surgery, and evaluate the feasibility of this technique in clinical application.
详细描述
The repositioning of maxillary segment is essential for esthetic and functional outcomes in orthognathic surgery. With the giant leap in three-dimensional (3D) computer-aided surgical simulation (CASS) technology development, surgeons are now able to simulate various surgical plans in a computer to achieve the best possible outcome. In order to transfer the virtual surgical plan to the patient at the time of the surgery, surgical splints manufactured by computer-aided design and manufacturing (CAD/CAM) technique has been traditionally used to intraoperative reposition the maxilla. Nonetheless, the position of maxilla is still dependent to mandibular autorotation. The instability of the mandibular condyle-fossa relationship is a potential problem that may directly affect the placement of the maxillary segment at the desired position. Personalized titanium plates manufactured using titanium 3D printing technique have been used for maxilla repositioning and fixation to improve the operative accuracy in orthognathic surgery. Despite this, the evidence for advantage of this personalized titanium plates technique is not very strong and based on only a few studies.
The purpose of this study is to determine whether personalized titanium plates can achieve better accuracy than CAD/CAM surgical splint in maxilla repositioning in orthognathic surgery. The accuracy of using both methods for maxilla repositioning was quantitatively evaluated using linear and angular measurement. Secondary outcomes include operative time, amount of intraoperative blood loss, preoperative preparation time and treatment cost will also be measured to evaluate the feasibility of clinical application of personalized titanium plates technique in orthognathic 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
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who were diagnosed with skeletal dentofacial deformity and scheduled to undergo orthognathic surgery including maxillary surgery
- •patients who were scheduled to undergo a computed tomography (CT) scan as a part of their diagnosis and treatment
- •patients who agreed to participate in this study
排除标准
- •Patients who had the previous orthognathic surgery
- •Patients who had the previous maxillary or mandibular trauma
- •Patients who had the maxillofacial tumor
- •Patients who required the segmental maxillary surgery
- •Oral soft tissues defect
- •Within the infection period
- •Craniofacial syndromes
- •Bone metabolism disturbance
- •Allergic to the titanium implant
- •Unable to give informed consent
- •Psychiatric disorders including dementia that may interfere with the study protocol
- •Pregnancy
- •Included in other studies
- •Severe craniomandibular disorders
研究组 & 干预措施
3D Printing Personalized Titanium Plate
After the LeFort I osteotomy, the intraoperative repositioning and fixation of the maxilla is accomplished using 3D printing personalized titanium plates.
干预措施: 3D Printing Personalized Titanium Plate (Device)
CAD/CAM Surgical Splint
After the LeFort I osteotomy, the intraoperative repositioning of the maxilla is accomplished using CAD/CAM surgical splints and the fixation of the maxilla is accomplished using commercialization titanium plates.
结局指标
主要结局
Difference of the maxillary position
时间窗: 3 days after the operation
Three landmark points (Upper dental midline between the 2 maxillary central incisal embrasure and both side mesiobuccal cusp of the upper 1st molar) were adopted on the maxilla, and the coordinates of these three landmarks were used to calculate the centroid of the maxilla. Positional differences of the centroid of the maxilla between the virtual plan and the actual result were measured.
次要结局
- Operative time(Operative day)
- Intraoperative blood loss(Operative day)
- Translational differences of the maxilla(3 days after the operation)
- Orientational differences of the maxilla(3 days after the operation)
研究者
wang xu dong
Director of Department of Oral and Craniomaxillofacial Surgery
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University