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平台转换与常规平台种植体:一项随机对照试验的加载后3年结果

Platform switching versus regular platform implants: 3-year post-loading results from a randomised controlled trial.

作者信息

Meloni Silvio Mario, Jovanovic Sascha Aleksandear, Pisano Milena, Tallarico Marco

出版信息

Eur J Oral Implantol. 2016;9(4):381-390.

Abstract

PURPOSE

To test the hypothesis that platform switching and regular platform implants would have different outcomes in single-tooth replacement against the alternative hypothesis of no difference.

MATERIAL 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 platform switching concept (PS group), or with matching implant-abutment diameters (RP group). A total of 36 Nobel Replace Tapered Groovy implants were installed. All the implants were inserted in healed bone, with an insertion torque between 35 and 45 Ncm, according to a one-stage protocol. Both implant types were loaded with a screw-retained temporary 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, radiographic marginal bone level (MBL) changes, pocket probing depth (PPD) and bleeding on probing (BOP). Clinical data was collected at implant placement (baseline), and at 3, 9 and 36 months after loading.

RESULTS: No patients dropped out and no implant failed. No prosthetic complications were recorded. One patient experienced mucosal inflammation with positive BOP (RP group) after 3 months, three patients had bilateral peri-implant mucosal inflammation with positive BOP at 6, 24 and 30 months after loading, respectively. There were no statistically significant differences between groups for complications (3/18 versus 4/18; P = 1.0; Odds Ratio = 1.333; 95% CI: 0.3467 to 5.1272). Nine months after loading, the mean MBL was 0.93 ± 0.26 mm in the RP group and 0.84 ± 0.23 mm in the PS group, with no statistically significant differences between groups (mean difference = 0.09 mm, 95% CI: -0.22 to 0.04, P = 0.18). Three years after loading, mean MBL was 1.09 ± 0.31 mm in the RP group and 1.06 ± 0.24 mm in the PS group, with no statistically significant differences between groups (mean difference = 0.02 mm, 95% CI: -0.06 to 0.10, P = 0.70). Marginal bone level changes between 3 years and baseline were 0.72 ± 0.28 mm in the RP group and 0.71 ± 0.27 mm in the PS group, with no statistically significant differences between the groups (mean difference = -0.00 mm, 95% CI: -0.07 to 0.07, P = 0.89). Mean PPD was 2.70 ± 0.52 mm in the RP group and 2.46 ± 0.69 mm in the PS group at 36 months after loading, with no statistically significant differences between the groups (mean difference = 0.23 mm, 95% CI: -0.05 to 0.35, P = 0.43). Mean BOP was 0.83 ± 0.96 mm in the RP group and 0.89 ± 0.99 mm in the PS group at 36 months after loading, with no statistically significant differences between the groups (mean difference = 0.07 mm, 95% CI: -0.03 to 0.17, P = 0.77).
 Conclusions: The clinical and radiographic outcomes of implants restored according to the platform-switching concept versus implants restored with the matching implant-abutment diameters are comparable, 3 years after loading. Conflict of interest statement: This study was not supported by any company. All authors declare no conflict of interest.

摘要

目的

检验平台转换种植体与常规种植体在单颗牙种植修复中效果不同这一假设,以对抗无差异的备择假设。

材料与方法

本研究设计为一项随机对照半口试验。连续纳入18例双侧单颗前磨牙或磨牙缺失、拟采用种植支持单冠修复的患者。种植位点根据平台转换概念随机分配进行治疗(PS组),或采用匹配的种植体-基台直径(RP组)。共植入36颗Nobel Replace锥形凹槽种植体。所有种植体均植入愈合骨中,根据一期方案,植入扭矩在35至45 Ncm之间。两种种植体在植入后3个月均加载螺丝固位临时冠。2个月后交付最终的螺丝固位单冠。观察指标为种植体和修复体生存率、生物学和修复并发症、影像学边缘骨水平(MBL)变化、探诊深度(PPD)和探诊出血(BOP)。在种植体植入时(基线)以及加载后3、9和36个月收集临床数据。

结果

无患者退出,无种植体失败。未记录到修复并发症。1例患者在3个月后出现黏膜炎症伴BOP阳性(RP组),3例患者分别在加载后6、24和30个月出现双侧种植体周围黏膜炎症伴BOP阳性。两组并发症发生率无统计学显著差异(3/18 vs 4/18;P = 1.0;优势比 = 1.333;95% CI:0.3467至5.1272)。加载后9个月,RP组平均MBL为0.93±0.26 mm,PS组为0.84±0.23 mm,两组间无统计学显著差异(平均差异 = 0.09 mm,95% CI:-0.22至0.04,P = 0.18)。加载后3年,RP组平均MBL为1.09±0.31 mm,PS组为1.06±0.24 mm,两组间无统计学显著差异(平均差异 = 0.02 mm,95% CI:-0.06至0.10,P = 0.70)。3年与基线之间的边缘骨水平变化,RP组为0.72±0.28 mm,PS组为0.71±0.27 mm,两组间无统计学显著差异(平均差异 = -0.00 mm,95% CI:-0.07至0.07,P = 0.89)。加载后36个月,RP组平均PPD为2.70±0.52 mm,PS组为2.46±0.69 mm,两组间无统计学显著差异(平均差异 = 0.23 mm,95% CI:-0.05至0.35,P = 0.43)。加载后36个月,RP组平均BOP为0.83±0.96 mm,PS组为0.89±0.99 mm,两组间无统计学显著差异(平均差异 = 0.07 mm,95% CI:-0.03至0.17,P = 0.77)。

结论

加载3年后,根据平台转换概念修复的种植体与采用匹配种植体-基台直径修复的种植体在临床和影像学结果上具有可比性。利益冲突声明:本研究未得到任何公司支持。所有作者均声明无利益冲突。

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