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随机对照临床试验:磷酸钙涂层和传统喷砂酸蚀表面种植体的对比研究——种植体 1 年存活率和边缘骨吸收水平的研究

Randomized controlled clinical trial on calcium phosphate coated and conventional SLA surface implants: 1-year study on survival rate and marginal bone level.

机构信息

Department of Periodontology, Research Institute of Periodontal Regeneration, College of Dentistry, Yonsei University, Seoul, Republic of Korea.

出版信息

Clin Implant Dent Relat Res. 2019 Oct;21(5):995-1001. doi: 10.1111/cid.12823. Epub 2019 Jul 17.

Abstract

BACKGROUND

Calcium phosphate (CaP)-coated surface showed enhanced contact osteogenesis around dental implant and finally accelerate osseointegration in early healing phase.

PURPOSE

The aim of this randomized controlled trial was to compare the peri-implant marginal bone level around uncoated and CaP-coated sandblasted, large-grit, acid-etched (SLA) surface implants during the first year after placement.

MATERIALS AND METHODS

This study was performed upon 34 patients with randomized and double-blinded design. Clinical and radiographic examinations were performed immediately after implant placement, at re-entry after 3 months, and after 12 months to evaluate the initial stability and change in the marginal bone level. The distance from the implant shoulder to the top of the bone-to-implant contact was defined as the marginal bone level, and its alteration was measured at 1 year after implant installation.

RESULTS

None of the implants failed, and most of them showed a marginal bone loss of less than 1 mm. Small changes in the bone level were noted at all sites in the control and test groups, and there were no clinically significant differences in the changes in the marginal bone.

CONCLUSION

Both CaP-coated and uncoated SLA surface implants showed comparably successful marginal bone stability without any complications during the first year after placement.

摘要

背景

磷酸钙(CaP)涂层表面可增强种植体周围的接触性成骨作用,最终在早期愈合阶段加速骨整合。

目的

本随机对照试验旨在比较未经涂层和 CaP 涂层喷砂、大颗粒、酸蚀(SLA)表面种植体在植入后第 1 年的种植体边缘骨水平。

材料和方法

本研究采用随机、双盲设计,共纳入 34 例患者。在种植体植入后即刻、植入后 3 个月时的再次进入以及植入后 12 个月时进行临床和影像学检查,以评估初始稳定性和边缘骨水平的变化。将种植体肩台到骨-种植体接触点顶部的距离定义为边缘骨水平,并在种植体安装后 1 年测量其变化。

结果

所有种植体均未失败,其中大多数种植体的边缘骨丧失小于 1mm。在对照组和试验组的所有部位,骨水平均有微小变化,边缘骨的变化无临床意义差异。

结论

在植入后第 1 年,CaP 涂层和未涂层 SLA 表面种植体均表现出相似的边缘骨稳定性,无任何并发症。

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