Department of Oral and Maxillofacial Surgery, Institute of Dental Studies and Technologies (IDST), Modinagar, Uttar Pradesh, India.
J Craniomaxillofac Surg. 2021 Nov;49(11):1026-1034. doi: 10.1016/j.jcms.2021.01.026. Epub 2021 Feb 6.
The aim of the study was to conduct a randomized clinical trial comparing the efficacy of standard non-compression miniplate and 3-dimensional (3D) titanium plate in the open reduction internal fixation (ORIF) of the mandibular condylar fractures. Patients who underwent open reduction of mandibular condylar fracture were recruited for the study. The patients satisfying the inclusion criteria were randomly assigned to two groups in a 1:1 ratio. Group A comprised patients treated using conventional miniplates, and Group B comprised patients treated using 3D Delta Plate. Informed consent was provided. All the patients underwent ORIF under GA via retromandibular approach. The sample size was set at 20 participants, with 10 participants in each group who were randomly allocated. Our study showed that patients in Group A had a significant statistical difference operating time (141.20 ± 2.59 min) than that of Group B (117.2 ± 9.63 min). Mouth opening was significantly greater in the 3-month follow-up in Group B (mean = 42.40 ± 1.82) compared to Group A (mean = 35.80 ± 1.30). Biting efficiency in Group B was observed to be clinically and statistically better compared to Group A (P = 0.012). Wound dehiscence was managed efficiently by judicious use of antibiotics and wounds were free of any signs of infections or discharge in the consecutive follow-ups. No plate removal was required in either group. Patients treated with 3D delta plates have superior outcomes with regard to operation time, mouth opening, and biting efficiency compared with miniplates. Hence, it can be concluded that the triangular shape of the 3D Delta plate allows the stress distribution to be superior and multidimensional, leading to better post-operative stability, faster healing, and reduced complications.
本研究旨在进行一项随机临床试验，比较标准非压缩微型板和 3 维（3D）钛板在髁突骨折切开复位内固定（ORIF）中的疗效。招募接受下颌髁突骨折切开复位的患者进行研究。符合纳入标准的患者以 1:1 的比例随机分为两组。A 组患者采用常规微型板治疗，B 组患者采用 3D Delta 板治疗。患者签署知情同意书。所有患者均在全身麻醉下经下颌后入路行 ORIF。样本量设定为 20 例，每组 10 例，随机分配。我们的研究表明，A 组患者的手术时间（141.20±2.59min）明显长于 B 组（117.2±9.63min），差异有统计学意义。B 组患者在 3 个月随访时张口度明显大于 A 组（均值=42.40±1.82），A 组（均值=35.80±1.30），差异有统计学意义。与 A 组相比，B 组的咬合效率明显更好，且差异有统计学意义（P=0.012）。B 组患者经合理使用抗生素后，伤口均愈合良好，无任何感染或渗出迹象。两组均无需取出钢板。与微型板相比，3D 三角板治疗的患者在手术时间、张口度和咬合效率方面的结果更优。因此，可以得出结论，3D Delta 板的三角形形状可使应力分布更优越、更多维，从而导致更好的术后稳定性、更快的愈合和减少并发症。
