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系统抗生素对种植体治疗的临床和患者报告结局的影响——一项多中心随机对照临床试验。

Effect of systemic antibiotics on clinical and patient-reported outcomes of implant therapy - a multicenter randomized controlled clinical trial.

机构信息

National Dental Centre Singapore, Singapore, Singapore.

出版信息

Clin Oral Implants Res. 2014 Feb;25(2):185-93. doi: 10.1111/clr.12098. Epub 2013 Jan 24.

DOI:10.1111/clr.12098
PMID:23347336
Abstract

OBJECTIVES

To determine the effect of various systemic antibiotic prophylaxis regimes on patient-reported outcomes and postsurgical complications in patients undergoing conventional implant installation.

MATERIAL AND METHODS

Three hundred and twenty-nine healthy adults in need of conventional implant installation were randomly assigned to one of four groups: (i) preoperatively 2 g of amoxycillin 1 h before surgery (positive control, PC), (ii) postoperatively 2 g of amoxycillin immediately following surgery (test 1, T1), (iii) preoperatively 2 g of amoxycillin 1 h before and 500 mg thrice daily on days 2 and 3 after surgery (test 2, T2), (iv) preoperatively 2 g of placebo 1 h before surgery (negative control, NC). Subjects were examined clinically by blinded examiners over 8 weeks after implant installation. In addition, Visual Analogue Scales (VAS) for pain, swelling, bruising and bleeding were obtained over 14 days. ANOVA was performed for the VAS. Chi-square tests were applied for postsurgical complications.

RESULTS

All VAS scores were low for all groups and decreased over time (P < 0.001). There were no significant differences for the VAS scores between the various groups at any time point (P > 0.05). There was only a significant difference in flap closure at week 4, where NC had 5% of the subjects not achieving complete wound closure compared to 0% for the three other groups (P = 0.01), with no other significant differences for any postsurgical complications (P > 0.05).

CONCLUSION

For standard single implant placement, prophylactic systemic antibiotics either before or after, or before and after the surgical procedure do not improve patient-reported outcomes or prevalence of postsurgical complications.

摘要

目的

确定不同全身抗生素预防方案对接受常规种植体植入术患者的患者报告结局和术后并发症的影响。

材料和方法

329 名需要常规种植体植入的健康成年人被随机分为四组之一:(i)术前 1 小时给予 2g 阿莫西林(阳性对照,PC),(ii)术后立即给予 2g 阿莫西林(试验 1,T1),(iii)术前 1 小时给予 2g 阿莫西林,术后第 2 天和第 3 天每天给予 500mg 阿莫西林 3 次(试验 2,T2),(iv)术前 1 小时给予 2g 安慰剂(阴性对照,NC)。在植入物植入后 8 周,由盲法检查者进行临床检查。此外,在 14 天内获得疼痛、肿胀、瘀伤和出血的视觉模拟量表(VAS)评分。对 VAS 进行方差分析。对术后并发症应用卡方检验。

结果

所有组的 VAS 评分均较低,且随时间降低(P<0.001)。在任何时间点,各组之间的 VAS 评分均无显著差异(P>0.05)。仅在第 4 周的瓣关闭时存在显著差异,NC 组有 5%的受试者未达到完全伤口闭合,而其他三组均为 0%(P=0.01),且无其他术后并发症的显著差异(P>0.05)。

结论

对于标准的单牙种植体植入术,手术前后预防性给予全身抗生素并不能改善患者报告的结局或术后并发症的发生率。

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