Division of Oral and Maxillofacial Surgery, Department of Dentistry, Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, Republic of Korea.
R&D Center, Megagen Implant Co., Ltd, Daegu, Republic of Korea.
Sci Rep. 2024 Oct 26;14(1):25522. doi: 10.1038/s41598-024-77211-1.
The aim of this study was to evaluate safety and efficacy of a poly-L-lactic acid (PLLA)-coated magnesium (Mg)-Dysprosium (Dy) membrane in guided bone regeneration (GBR) using a rabbit calvarium model. The microstructure of the Mg-Dy membrane surface and thickness of the PLLA coating were examined. In vitro degradation and cytotoxicity test was conducted. The in vivo study used 24 white male rabbits with two 8 mm-diameter defects created on the calvaria; 12 defects were randomly assigned per group: (1) Negative control, (2) positive control, (3) uncoated Mg, and (4) PLLA-coated Mg group. Specimens were harvested at 4, 8, and 12 weeks postoperatively for radiological, histological, and histomorphometric analyses. The PLLA-coated Mg-Dy membrane showed a low degree of degradation, indicating that the coating exerted a protective effect. In the cytotoxicity test, no deformed or degenerated cells were observed. In the in vivo study, radiographic and histomorphometric analyses indicated favorable new bone formation and maintenance of the graft material for PLLA-coated Mg group. PLLA-coated Mg group, compared to the uncoated counterpart, restored the bony contour more completely, without inducing significant inflammatory response. Our results support the safety and efficacy of PLLA-coated Mg-Dy membranes for GBR both in vitro and in vivo.
本研究旨在评估聚左旋乳酸（PLLA）涂层镁（Mg）-镝（Dy）膜在兔颅骨模型中用于引导骨再生（GBR）的安全性和有效性。检查了 Mg-Dy 膜表面的微观结构和 PLLA 涂层的厚度。进行了体外降解和细胞毒性测试。体内研究使用 24 只雄性白兔，在颅骨上创建了两个 8 毫米直径的缺损；每个组随机分配 12 个缺损：（1）阴性对照，（2）阳性对照，（3）未涂层 Mg，和（4）PLLA 涂层 Mg 组。术后 4、8 和 12 周采集标本进行放射学、组织学和组织形态计量学分析。PLLA 涂层 Mg-Dy 膜表现出低降解程度，表明涂层具有保护作用。在细胞毒性测试中，未观察到变形或退化的细胞。在体内研究中，放射学和组织形态计量学分析表明 PLLA 涂层 Mg 组有良好的新骨形成和移植物材料的维持。与未涂层组相比，PLLA 涂层 Mg 组更完全地恢复了骨轮廓，且没有引起明显的炎症反应。我们的结果支持 PLLA 涂层 Mg-Dy 膜在体外和体内用于 GBR 的安全性和有效性。
