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平台转换与常规平台单颗种植体:一项随机对照临床试验的 5 年加载后结果。

Platform switching versus regular platform single implants: 5-year post-loading results from a randomised controlled trial.

出版信息

Int J Oral Implantol (Berl). 2020;13(1):43-52.

Abstract

PURPOSE

To compare the clinical and radiographic outcomes of platform switching (PS) and regular platform (RP) implants.

MATERIALS AND METHODS

This study was designed as a randomised controlled split-mouth trial. Eighteen patients, with bilaterally missing single premolars or molars to be restored with implant-supported single crowns, were consecutively enrolled. Implant sites were randomly assigned to be treated according to the PS concept (PS group), or with matching implant-abutment diameters (RP group). A total of 36 implants were placed in healed bone, with an insertion torque between 35 and 45 Ncm, according to a one-stage protocol. All the implants were loaded with a screw-retained provisional crown 3 months after implant insertion. Definitive screw-retained single crowns were delivered 2 months later. Outcome measures were implant and prosthetic survival rates, biological and prosthetic complications, marginal bone level (MBL) changes, pocket probing depth (PPD) and bleeding on probing (BOP). Clinical data were collected at implant placement (baseline), implant loading (3 months later) and at 9, 36 and 60 months after loading.

RESULTS

One patient dropped out after 4 years of follow-up. No implant failed and no prosthetic complications were recorded during the study period. One patient experienced mucosal inflammation with positive BOP (RP group) after 3 months and three patients had bilateral peri-implant mucosal inflammation with positive BOP at 6, 24 and 36 months, respectively. No other biological complications were recorded up to 60 months of follow-up. There were no statistically significant differences between groups for complications (3/18 versus 4/18; P = 1.0). Nine months after loading the mean MBL was 0.93 ± 0.26 mm (95% CI 0.81 to 1.05) for RP implants and 0.84 ± 0.23 mm (95% CI 0.73 to 0.95) for PS implants. No statistically significant difference was observed between the groups (P = 0.18). Thirty-six months after loading, the mean MBL was 1.09 ± 0.31 mm (95% CI 0.95 to 1.24) in the RP group and 1.06 ± 0.24 mm (95% CI 0.94 to 1.17) in the PS group, with no statistically significant difference between groups (P = 0.70). Sixty months after loading the mean MBL was 1.24 ± 0.39 mm (95% CI 1.05 to 1.43) in the RP group and 1.20 ± 0.21 mm (95% CI 1.01 to 1.39) in the PS group, with no statistically significant difference between the groups (P = 0.85). The mean PPD was 2.58 ± 0.58 mm (95% CI 2.32 to 2.84) in the RP group and 2.40 ± 0.72 mm (95% CI 2.21 to 2.59) in the PS group at 60 months follow-up, with no statistically significant difference between the groups (P = 0.49). The mean BOP was 0.90 ± 0.88 (95% CI 0.58 to 1.22) in the RP group and 0.93 ± 0.97 (95% CI 0.51 to 1.35) in the PS group at 60 months of follow-up, with no statistically significant difference between the groups (P = 0.85).

CONCLUSIONS

Implants restored according to the PS concept and matching implant-abutment diameters showed comparable clinical and radiographic results up to 5 years after loading.

摘要

目的

比较平台转换(PS)和常规平台(RP)种植体的临床和影像学结果。

材料和方法

本研究设计为随机对照分面试验。连续纳入 18 名双侧缺失单前磨牙或磨牙,拟用种植体支持的单冠修复的患者。将种植部位随机分配,根据 PS 概念(PS 组)或匹配种植体-基台直径(RP 组)进行治疗。所有种植体均按照一期方案在愈合骨中植入,旋入扭矩为 35 至 45 Ncm。所有种植体均在植入后 3 个月用螺丝固位临时冠修复,2 个月后用螺丝固位单冠修复。测量指标包括种植体和修复体的存活率、生物学和修复体并发症、边缘骨水平(MBL)变化、探诊深度(PPD)和探诊出血(BOP)。临床数据在种植体植入(基线)、种植体加载(3 个月后)以及加载后 9、36 和 60 个月时收集。

结果

1 名患者在 4 年随访后脱落。研究期间,无种植体失败,无修复体并发症。1 名患者在 3 个月时出现黏膜炎症伴 BOP 阳性(RP 组),3 名患者分别在 6、24 和 36 个月时出现双侧种植体周围黏膜炎症伴 BOP 阳性。在 60 个月的随访中,无其他生物学并发症记录。两组并发症发生率(3/18 与 4/18;P = 1.0)无统计学差异。加载后 9 个月,RP 种植体的平均 MBL 为 0.93 ± 0.26 mm(95%CI 0.81 至 1.05),PS 种植体的平均 MBL 为 0.84 ± 0.23 mm(95%CI 0.73 至 0.95)。两组间无统计学差异(P = 0.18)。加载后 36 个月,RP 组的平均 MBL 为 1.09 ± 0.31 mm(95%CI 0.95 至 1.24),PS 组的平均 MBL 为 1.06 ± 0.24 mm(95%CI 0.94 至 1.17),两组间无统计学差异(P = 0.70)。加载后 60 个月,RP 组的平均 MBL 为 1.24 ± 0.39 mm(95%CI 1.05 至 1.43),PS 组的平均 MBL 为 1.20 ± 0.21 mm(95%CI 1.01 至 1.39),两组间无统计学差异(P = 0.85)。60 个月随访时,RP 组的平均 PPD 为 2.58 ± 0.58 mm(95%CI 2.32 至 2.84),PS 组的平均 PPD 为 2.40 ± 0.72 mm(95%CI 2.21 至 2.59),两组间无统计学差异(P = 0.49)。RP 组的平均 BOP 为 0.90 ± 0.88(95%CI 0.58 至 1.22),PS 组的平均 BOP 为 0.93 ± 0.97(95%CI 0.51 至 1.35),两组间无统计学差异(P = 0.85)。

结论

按照 PS 概念和匹配种植体-基台直径设计的种植体在加载后 5 年内显示出相似的临床和影像学结果。

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