ObjectiveThe aim of this non‐inferiority randomized clinical trial was to compare the surgical and healing complications, vertical bone gain, and volumetric bone changes after vertical ridge augmentation using two different approaches: customized Ti‐reinforced d‐PTFE mesh versus customized CAD/CAM Ti‐mesh.Materials and MethodsFifty patients with vertical bone defects were randomly treated with Ti‐reinforced d‐PTFE mesh (control group) or CAD/CAM Ti‐mesh (test group) and a mix of autogenous bone and deproteinized bovine bone matrix. Surgical and healing complication rates (SCR‐HCR), vertical bone gain (VBG), regenerated bone volume (RBV), and regeneration rates (RR and ERR) were recorded and analysed [significance level (α) of 0.05].ResultsOf the 50 patients, 48 underwent bone augmentation surgery. SCR were 4% and 12% in PTFE and Ti‐mesh, whereas HCR were 12.5% and 8.3%. VBG were 5.79 ± 1.71 mm (range: 3.2–8.8 mm) in the PTFE group and 5.18 ± 1.61 mm (range: 3.1–8.0 mm) in the Ti‐mesh group (p = .233), whereas RBV were 1.46 ± 0.48 cc and 1.26 ± 0.55. RR was 99.5% and 87.0%, demonstrating a statistically significant difference (p = .013). Finally, the values related to pseudo‐periosteum, bone density, and implant stability were similar in the two study groups. Osseointegration rates were 98.2% and 98.3%.ConclusionsThis study confirmed the non‐inferiority of customized CAD/CAM titanium meshes with respect to reinforced PTFE meshes in terms of surgical and healing complications. Although PTFE meshes showed higher vertical bone gain and regeneration rates than Ti‐meshes, no significant differences were found.

中文翻译：

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并发症、垂直骨增益、使用定制增强 PTFE 网或 Ti 网进行垂直嵴增强后的体积变化。一项非劣效性随机临床试验


目的这项非劣效性随机临床试验的目的是使用两种不同的方法比较垂直嵴增强后的手术和愈合并发症、垂直骨增益和体积骨变化：定制的 Ti 增强 d-PTFE 网与定制的 CAD/CAM Ti-网。材料和方法50 例垂直骨缺损患者随机接受 Ti 增强 d-PTFE 网片 （对照组） 或 CAD/CAM Ti 网片 （试验组） 以及自体骨和脱蛋白牛骨基质的混合物治疗。记录和分析手术和愈合并发症发生率 （SCR-HCR）、垂直骨增益 （VBG）、再生骨量 （RBV） 和再生率 （RR 和 ERR） [显着性水平 （α） 为 0.05]。结果50 例患者中，48 例接受了骨增量手术。PTFE 和 Ti 网的 SCR 分别为 4% 和 12%，而 HCR 分别为 12.5% 和 8.3%。PTFE 组的 VBG 为 5.79 ± 1.71 毫米（范围：3.2-8.8 毫米），钛网组为 5.18 ± 1.61 毫米（范围：3.1-8.0 毫米）（p = .233），而 RBV 分别为 1.46 ± 0.48 cc 和 1.26 ± 0.55。RR 分别为 99.5% 和 87.0%，显示出统计学上的显著差异 （p = .013）。最后，两个研究组中与假骨膜、骨密度和种植体稳定性相关的值相似。骨整合率分别为 98.2% 和 98.3%。结论本研究证实了定制 CAD/CAM 钛网在手术和愈合并发症方面优于增强 PTFE 网。尽管 PTFE 网显示出比 Ti 网更高的垂直骨增益和再生速率，但没有发现显着差异。