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使用定制增强聚四氟乙烯网片或钛网进行垂直牙槽嵴增高术后的并发症、垂直骨增量及体积变化。一项非劣效性随机临床试验。

Complication, vertical bone gain, volumetric changes after vertical ridge augmentation using customized reinforced PTFE mesh or Ti-mesh. A non-inferiority randomized clinical trial.

作者信息

Cucchi Alessandro, Bettini Sofia, Tedeschi Lucia, Urban Istvan, Franceschi Debora, Fiorino Antonino, Corinaldesi Giuseppe

机构信息

Private Practice, Bologna, Italy.

Implant Center for Edentulism and Jawbone Atrophies, Maxillofacial Surgery and Odontostomatology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.

出版信息

Clin Oral Implants Res. 2024 Dec;35(12):1616-1639. doi: 10.1111/clr.14350. Epub 2024 Aug 23.

DOI:10.1111/clr.14350
PMID:39180274
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11629450/
Abstract

OBJECTIVE

The 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 METHODS

Fifty 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].

RESULTS

Of 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%.

CONCLUSIONS

This 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.

摘要

目的

本非劣效性随机临床试验的目的是比较采用两种不同方法进行垂直牙槽嵴增高术后的手术及愈合并发症、垂直骨增量和骨体积变化：定制钛增强膨体聚四氟乙烯（d-PTFE）网与定制计算机辅助设计/计算机辅助制造（CAD/CAM）钛网。

材料与方法

50例垂直骨缺损患者被随机分为钛增强d-PTFE网治疗组（对照组）或CAD/CAM钛网治疗组（试验组），并使用自体骨和脱蛋白牛骨基质混合物。记录并分析手术及愈合并发症发生率（SCR-HCR）、垂直骨增量（VBG）、再生骨体积（RBV）以及再生率（RR和ERR）[显著性水平（α）为0.05]。

结果

50例患者中，48例接受了骨增量手术。PTFE网组和钛网组的SCR分别为4%和12%，而HCR分别为12.5%和8.3%。PTFE网组的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 = 0.233），而RBV分别为1.46±0.48立方厘米和1.26±0.55立方厘米。RR分别为99.5%和87.0%，显示出统计学显著差异（p = 0.013）。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钛网在手术及愈合并发症方面相对于增强PTFE网的非劣效性。尽管PTFE网显示出比钛网更高的垂直骨增量和再生率，但未发现显著差异。

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