钛增强型 d-PTFE 膜或钛网与胶原膜行牙槽嵴增高术（VRA）：一项随机临床试验的 1 年结果。

Vertical ridge augmentation (VRA) with Ti-reinforced d-PTFE membranes or Ti meshes and collagen membranes: 1-year results of a randomized clinical trial.

机构信息

Private Practice, Bologna, Italy.

Unit of Oral and Maxillofacial Surgery, Department of Biomedical and Neuromotor Science (DIBINEM), Alma Mater Studiorum-University of Bologna, Bologna, Italy.

出版信息

Clin Oral Implants Res. 2021 Jan;32(1):1-14. doi: 10.1111/clr.13673. Epub 2020 Oct 19.

DOI:10.1111/clr.13673

PMID:33017060

Abstract

OBJECTIVES

The aim of this study was to evaluate hard and soft tissues around implants placed in posterior mandible 1 year after vertical ridge augmentation (VRA).

MATERIALS AND METHODS

40 patients with vertical defects were enrolled and treated according to the study protocol. Patients were randomly divided into two study groups: reinforced PTFE membranes (group A) and titanium meshes plus collagen membranes (group B). All patients received simultaneous implants which were evaluated after prosthetic restoration at baseline and after 1 year, using the following parameters: peri-implant bone levels (PBLs), interproximal bone peaks (IBPs), pocket probing depth (PPD), bleeding on probing (BoP), plaque index (mPI), gingival index (mGI), keratinized tissue thickness/width (tKT and wKT), and fornix depth (FD). Statistical analysis was performed to investigate any statistically significant differences and/or correlations (p = .05).

RESULTS

30 patients were completely followed up according to the study protocol. After 1 year, implants showed a change in PBL from 0.12 to 0.76 mm, with marginal bone loss of 0.67 and 0.61 mm for group A and group B, respectively, without significant differences (p > .9337). The estimated difference between treatments for the change from baseline in PBL was -0.05 (95% CI -0.27 to 0.16). Statistical analysis revealed strong correlations between PBL and IBP (p < .0001). However, no significant differences were observed for PPD, mPI, mGI, tKT, wKT, and FD (p > .05).

CONCLUSION

The results indicate that GBR treatment with titanium meshes plus collagen membranes (Group B) compared to reinforced PTFE membranes does not appear to be inferior or superior in terms of PBL change. In both groups, hard and soft tissues were stable after 1 year of follow-up, with a peri-implant bone loss less than 1.0 mm in the first year (study registered at ClinicalTrials.gov NCT04332679).

摘要

目的

本研究旨在评估垂直骨增量（VRA） 1 年后下颌后牙区种植体周围的硬组织和软组织情况。

材料和方法

纳入 40 名垂直骨缺损患者，按照研究方案进行治疗。患者随机分为两组：增强型聚四氟乙烯膜（A 组）和钛网加胶原膜（B 组）。所有患者均接受同期种植，在修复后基线和 1 年后进行评估，采用以下参数：种植体周围骨水平（PBL）、近中骨峰（IBP）、探诊深度（PPD）、探诊出血（BoP）、菌斑指数（mPI）、牙龈指数（mGI）、角化组织厚度/宽度（tKT 和 wKT）和沟内附着水平（FD）。采用统计学分析方法来研究任何具有统计学意义的差异和/或相关性（p=.05）。

结果

根据研究方案，30 名患者得到了完全随访。1 年后，种植体的 PBL 从 0.12 变为 0.76mm，A 组和 B 组的边缘骨丧失分别为 0.67mm 和 0.61mm，无显著差异（p>.9337）。从基线 PBL 变化的治疗估计差异为-0.05（95%CI -0.27 至 0.16）。统计学分析显示 PBL 与 IBP 之间存在很强的相关性（p<0.0001）。然而，PPD、mPI、mGI、tKT、wKT 和 FD 无显著差异（p>.05）。

结论

结果表明，与增强型聚四氟乙烯膜（A 组）相比，钛网加胶原膜（B 组）的 GBR 治疗在 PBL 变化方面并不劣于或优于后者。在两组中，经过 1 年的随访，硬组织和软组织均稳定，第一年的种植体周围骨丢失小于 1.0mm（研究在 ClinicalTrials.gov 注册，编号为 NCT04332679）。