Department of Oral and Maxillofacial Surgery, Odense University Hospital, Sdr. Boulevard 29, 5000, Odense, Denmark; Department of Clinical Institute, Faculty of Health, University of Southern Denmark, Winsløwparken 19, 5000, Odense, Denmark.
Department of Technology and Innovation, Faculty of Engineering, University of Southern Denmark, Campusvej 55, 5230, Odense, Denmark.
J Craniomaxillofac Surg. 2019 Mar;47(3):394-399. doi: 10.1016/j.jcms.2018.12.015. Epub 2019 Jan 3.
Selective laser melting used to manufacture patient-specific 3D-printed (PSP) plates is a delicate process, which may introduce weakened areas in the plates, with risk of fracture. This in vitro study's purpose was to test the ability of PSP plates to stabilize Le Fort I osteotomies compared with manually adapted stock plates. The study's objectives were to measure the force needed to compress the osteotomy and evaluate whether the PSP plates would break during compression.
This controlled in vitro study evaluated the maxillary stability using the clinical data from 7 patients. The virtually planned maxillary reposition was 3D-printed in 2 copies, and the osteotomy gap was fixated by either PSP plates or stock plates. The models were compressed until the Le Fort I osteotomy gap was eliminated. The primary outcome was the force needed to compress the model. The primary predictor variable was a comparison between PSP and stock plates. Secondary outcome measurements were the slope of elastic modulus, yield point, and force needed for 2 mm compression. Statistical testing was performed by Wilcoxon signed-rank test with significance level at P ≤ 0.05.
The PSP plates performed better than stock plates in all outcome measurements. None of the plates broke during compression despite forces of more than 4000 N. The first point of failure in PSP plates was the first screw cranial to the osteotomy. In comparison, the first point of failure in stock plates was in the plates' bend at the osteotomy.
In this in vitro setup, the Le Fort I osteotomies fixated with PSP plates were more stable than the osteotomies fixated with conventional stock plates. No adverse effects occurred during testing of PSP plates; thus, PSP plates seem to be a safe alternative to stock plates and may even be preferable.
使用选择性激光熔化制造患者特定的 3D 打印（PSP）板是一个精细的过程，这可能会在板中引入弱化区域，从而增加骨折的风险。本体外研究的目的是测试 PSP 板相对于手动适配的库存板稳定 Le Fort I 骨折的能力。该研究的目的是测量压缩骨折所需的力，并评估 PSP 板是否会在压缩过程中破裂。
本对照体外研究使用来自 7 名患者的临床数据评估上颌稳定性。虚拟计划的上颌复位以 2 个副本 3D 打印，通过 PSP 板或库存板固定骨折间隙。模型被压缩，直到 Le Fort I 骨折间隙消除。主要结果是压缩模型所需的力。主要预测变量是 PSP 和库存板之间的比较。次要结果测量是弹性模量、屈服点和 2mm 压缩所需力的斜率。统计检验采用 Wilcoxon 符号秩检验，显著性水平 P≤0.05。
在所有结果测量中，PSP 板的性能均优于库存板。尽管力超过 4000N，但在压缩过程中没有一块板破裂。PSP 板的第一个失效点是骨折线上方的第一个颅侧螺钉。相比之下，库存板的第一个失效点是在骨折处的板弯曲处。
在本体外设置中，使用 PSP 板固定的 Le Fort I 骨折比使用传统库存板固定的骨折更稳定。在 PSP 板的测试中没有出现不良反应；因此，PSP 板似乎是库存板的安全替代品，甚至可能更优。
