摘要/Abstract
摘要： 目的·介绍定制型颞下颌关节（temporomandibular joint，TMJ）-下颌骨联合假体的设计制造过程，并初步验证其临床应用的安全性、有效性和精确性。方法·收集6例TMJ-下颌骨联合病变患者，将术前颌面部CT数据导入Mimic 18.0 软件中，个性化设计符合TMJ和下颌骨解剖结构和运动特征的TMJ-下颌骨联合假体，通过五轴精加工和3D打印等技术进行制造。手术选择改良耳颞、颌后和颌下切口，显露TMJ-下颌骨联合病变后完整切除；制备游离髂骨或带蒂腓骨肌皮瓣，并固定于联合假体内侧面，将该联合假体和自体骨共同植入缺损处并固定。术后分别进行临床指标和影像学检查，进行安全性和有效性评价；并将术前设计假体和术后假体的植入位置进行拟合，分析假体植入的精确性。结果·6例患者术中假体和自体骨均顺利就位且固定牢固。平均随访19个月后，术后疼痛、饮食、下颌运动和张口度均有明显的改善；术后X线和CT检查均显示假体未见明显松动、移位、断裂等；术前和术后拟合结果显示，关节窝假体植入的平均误差为（0.891±0.127）mm，下颌假体为（1.240±0.246）mm，总体为（1.122±0.198）mm。结论·自行研制的定制型TMJ-下颌骨联合假体在临床应用中具有较好的安全性、有效性和精准性。
关键词: 颞下颌关节, 下颌骨, 联合假体, 定制型, 3D打印
Abstract:
Objective · To introduce the design and manufacture of the custom-made temporomandibular joint (TMJ)-mandible prosthesis and evaluate its safety, effectiveness and accuracy in clinical application. Methods · Six patients with the TMJ osteoarthrosis were included in this study. The maxillofacial CT data for all the patients were obtained and transferred into the Mimics 18.0 software preoperatively. The custom-made TMJ-mandible prosthesis was designed based on the anatomy and movement of the TMJ, and fabricated by 3D printing and 5-axis milling technologies. The TMJ-mandible lesion has been removed completely from modified preauricular, post and sub mandibular incisions. The combined prosthesis has been implanted after complete lesion resection. Then, the iliac or fibular bone has been grafted and fixed in the medial side of the prosthesis. The clinical follow-up and radiography examinations were taken after surgery to assess the safety and effectiveness for using. The postoperative CT scan was used to measure the implanted deviation compared with the preoperative design. Results · During the operations, all prosthesis were positioned smoothly, easily adapted to the bone surfaces, and fixed excellently. There were no prosthesis displacement, loosening, and fracture in X-ray postoperatively. The pain, diet, mandibular movement and open mouth had significant improvements after 19 months' follow-up. The merged postoperative CT scans indicated that the mean differences between predesigned positions of prosthesis and postoperative implantation sites were (0.891±0.127) mm for the fossa component and (1.240±0.246) mm for the mandibular component. The total average error was (1.122±0.198) mm. Conclusion · The TMJ-mandible combined prosthesis is safe, effective, and precise for the clinical application.
Key words: temporomandibular joint, mandible, combined prosthesis, custom-made, 3D printing
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