Saleh Hiba Obad, Moussa Basma Gamal, Salah Eddin Khaled Amr, Noman Samer Abduljabar, Salah Ahmed Mohammed
Department Oral & Maxillofacial Surgery, Faculty of Dentistry, Cairo University, Cairo, Egypt.
Department of Oral & Maxillofacial Surgery, Ahmed Maher Teaching Hospital, Cairo, Egypt.
J Maxillofac Oral Surg. 2023 Dec;22(4):995-1005. doi: 10.1007/s12663-023-02027-x. Epub 2023 Oct 27.
Mandibular angle is the most common site for fractures, accounting for 23-42% of all cases of mandibular fractures. A customized fixation system is designed directly for a specific patient, which reduces the time spent bending and fixing the plate during the operation. This study was designed to assess the effect of CAD/CAM customized V pattern plate versus standard miniplates fixation in mandibular angle fracture.
This prospective randomized clinical trial included 26 patients suffering from mandibular angle fracture. Patients were selected from Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Cairo University and Ahmed Maher Teaching Hospital. Study group (13) needed open reduction and internal fixation by using CAD/CAM V plate with surgical guide, while control group (13) needed open reduction and internal fixation by using standard superior-inferior miniplate fixation. The patients were then followed up for one year postoperatively.
It showed that there was a statistical difference between the study group and the control group regarding postoperative pain, occlusion, and maximal interincisal opening ( value < 0.05%). There was no statistical difference ( value > 0.05%) in the postoperative panoramic radiograph that was taken within the postoperative 1st week in both groups, while the increase in mean bone density was statistically significant ( value < 0.05%) from 6 months to one year postoperatively.
CAD/CAM customized V pattern plate is a suitable plate design because it offers sufficient stability for normal bone healing, the creation of an ideal occlusion, an early return to function, and adequate postoperative radiographic outcomes.
It was registered at ClinicalTrials.gov. Registration number: NCT03761524. Registration date: 03.12.2018.
下颌角是骨折最常见的部位,占下颌骨骨折所有病例的23% - 42%。定制固定系统是直接为特定患者设计的,这减少了手术中弯曲和固定钢板所花费的时间。本研究旨在评估计算机辅助设计/计算机辅助制造(CAD/CAM)定制V形钢板与标准微型钢板固定在下颌角骨折中的效果。
这项前瞻性随机临床试验纳入了26例下颌角骨折患者。患者选自开罗大学牙科学院口腔颌面外科和艾哈迈德·马赫教学医院。研究组(13例)采用带手术导板的CAD/CAM V形钢板进行切开复位内固定,而对照组(13例)采用标准的上下微型钢板固定进行切开复位内固定。然后对患者进行术后一年的随访。
结果显示,研究组与对照组在术后疼痛、咬合关系和最大切牙间开口方面存在统计学差异(P值<0.05%)。两组术后第1周拍摄的全景X线片无统计学差异(P值>0.05%),而术后6个月至1年平均骨密度的增加具有统计学意义(P值<0.05%)。
CAD/CAM定制V形钢板是一种合适的钢板设计,因为它为正常骨愈合提供了足够的稳定性,创造了理想的咬合关系,功能恢复早,术后影像学结果良好。
该研究在ClinicalTrials.gov注册。注册号:NCT03761524。注册日期:2018年12月3日。