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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使用定制的增强 PTFE 网或钛网进行垂直牙槽嵴增量后的并发症、垂直骨增益、体积变化。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比较使用两种不同方法进行垂直牙槽嵴增量后的手术和愈合并发症、垂直骨增益和骨体积变化：定制 Ti 增强 d-PTFE 网与定制 CAD/CAM Ti材料和方法 50 例垂直骨缺损患者随机接受 Ti 增强 d-PTFE 网（对照组）或 CAD/CAM Ti-mesh（测试组）以及自体骨和脱蛋白牛骨基质的混合物治疗。记录并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 人接受了骨增量手术。 PTFE 和钛网中的 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 mm（范围：3.2–8.8 mm），Ti-mesh 组的 VBG 为 5.18 ± 1.61 mm（范围：3.1–8.0 mm）（p = .233），而 RBV 为 1.46 ± 0.48 cc 和 1.26 ± 0.55。 RR 分别为 99.5% 和 87.0%，显示出统计上显着的差异 (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，在手术和愈合并发症方面，定制 CAD/CAM 钛网相对于增强 PTFE 网并不逊色。尽管 PTFE 网比钛网表现出更高的垂直骨增益和再生率，但没有发现显着差异。