三维打印及三维微型钛板在下颌前部骨折治疗中的准确性评估:一项前瞻性临床研究。
Evaluation of accuracy of three-dimensional printing and three-dimensional miniplates in treatment of anterior mandibular fractures: a prospective clinical study.
作者信息
Abou Elkhier Mazen Tharwat, Saber Mohamed Elsayed, Sweedan Ahmed Ossama, Elashwah Adham
机构信息
Oral and Maxillofacial Surgery, Faculty of Dentistry, Alexandria University, Alexandria, Egypt.
出版信息
BMC Oral Health. 2025 Apr 28;25(1):649. doi: 10.1186/s12903-025-05935-1.
BACKGROUND
There are strong torsional forces acting on the anterior mandible fractures. Maxillofacial surgery makes extensive use of digital technology, and three-dimensional printing is now an integral element of the workflow in several areas of oral and maxillofacial surgery. Three-dimensional (3D) miniplates had been proposed by several researchers as a good option for mandibular fracture fixation. This clinical trial was conducted to evaluate the accuracy of virtual planning in anterior mandibular fixation by comparing postoperative outcomes with preoperative virtual planning and to evaluate bone healing by measuring bone density after using pre-bent 3D miniplates on a 3D model to complete a 3D workflow and to fix the mandible in 3D.
METHODS
15 Patients with anterior mandibular fractures were included in the study. All patients underwent computer tomography (CT) scan, and the data were imported into Mimics software. The unaffected healthy side was mirrored to the fractured side. Bone fixation three-dimensional plates were prebent and adapted on the model printed by the three-dimensional printing machine, submitted to sterilization, and were used for bone reduction and fixation. An immediate postoperative CT scan was taken to evaluate the accuracy of virtual planning and after 3 months for evaluation of bone healing.
RESULTS
Clinical observation revealed good stable occlusion, and there was no significant difference between the postoperative three-dimensional image of the mandible and the virtually reduced mandible in the preoperative plan, as there was no significant difference between the length and width between anatomical landmarks of the virtually reduced mandible and the postoperative plan (p > 0.05). The bone density measured by Hounsfield units (HU) measured on CT images after 3 months revealed good bone healing as compared to immediate postoperative values (P value < 0.05).
CONCLUSION
Digital workflow provides an accurate method for the reduction and fixation of anterior mandibular fractures. Also, 3D miniplates provide a good option for symphyseal and parasymphyseal fractures despite their limitations, as in some cases, like comminuted fractures and fractures in and around the mental foramen.
TRIAL REGISTRATION
This clinical trial was registered at Alexandria university, on 02/11/2021 under the registration number 0308 - 10/2021. All procedures involving human participants were performed in accordance with Research Ethics Committee, Faculty of Dentistry, Alexandria University under IRB No 00010556 and IORG No 0008839. The current study was retrospectively registered at ClinicalTrials.gov with the identification number NCT06898736 on 27/3/2025. However, all study protocols were predefined, with no deviations from the original methodology.
背景
前下颌骨骨折会受到强大的扭转力作用。颌面外科广泛应用数字技术,三维打印现已成为口腔颌面外科多个领域工作流程中不可或缺的一部分。几位研究人员提出三维(3D)微型钢板是下颌骨骨折固定的一个不错选择。本临床试验旨在通过比较术后结果与术前虚拟规划来评估前下颌骨固定中虚拟规划的准确性,并通过在三维模型上使用预弯3D微型钢板完成三维工作流程并在三维空间中固定下颌骨后测量骨密度来评估骨愈合情况。
方法
本研究纳入了15例前下颌骨骨折患者。所有患者均接受了计算机断层扫描(CT),数据被导入Mimics软件。将未受影响的健康侧镜像到骨折侧。骨固定三维钢板在三维打印机打印的模型上进行预弯和适配,进行消毒后用于骨折复位和固定。术后立即进行CT扫描以评估虚拟规划的准确性,3个月后进行评估以观察骨愈合情况。
结果
临床观察显示咬合稳定良好,下颌骨术后三维图像与术前计划中虚拟复位的下颌骨之间无显著差异,虚拟复位下颌骨与术后计划的解剖标志点之间的长度和宽度也无显著差异(p>0.05)。与术后即刻值相比,术后3个月在CT图像上用亨氏单位(HU)测量的骨密度显示骨愈合良好(P值<0.05)。
结论
数字工作流程为前下颌骨骨折的复位和固定提供了一种准确的方法。此外,尽管3D微型钢板存在局限性,但对于正中联合和正中旁骨折来说仍是一个不错的选择,比如在一些病例中,如粉碎性骨折以及颏孔内和周围的骨折。
试验注册
本临床试验于2021年11月2日在亚历山大大学注册,注册号为0308 - 10/2021。所有涉及人类参与者的程序均按照亚历山大大学牙科学院研究伦理委员会的要求进行,伦理审查委员会编号为00010556,国际机构审查委员会编号为0008839。本研究于202年3月27日在ClinicalTrials.gov上进行回顾性注册,识别号为NCT06898736。然而,所有研究方案均已预先确定,未偏离原始方法。
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