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单颗牙种植体植入抗生素预防的多中心安慰剂对照随机临床试验。

A multicentre placebo-controlled randomised clinical trial of antibiotic prophylaxis for placement of single dental implants.

作者信息

Anitua Eduardo, Aguirre José Javier, Gorosabel Alberto, Barrio Pedro, Errazquin José Miguel, Román Pedro, Pla Rafael, Carrete Javier, de Petro José, Orive Gorka

机构信息

Instituto Eduardo Anitua, Vitoria, Spain.

出版信息

Eur J Oral Implantol. 2009 Winter;2(4):283-92.

PMID:20467604
Abstract

PURPOSE

To compare the efficacy and safety of 2 g amoxicillin orally with identical placebo tablets 1 hour before implant placement when placing single implants in bone types II and III.

MATERIAL AND METHODS

12 private dental clinics in Spain agreed to participate in this trial. A total of 105 patients were recruited. Patients were randomised for consumption orally of 2g amoxicillin or identical placebo tablets. Only patients needing single implants were included. Outcome measures were post-operative infections, adverse events and implant failures. Characteristics of the saprophytic flora were also studied in all patients. Patients were seen 3 days, 10 days, 1 month and 3 months postoperatively.

RESULTS

A total of 105 patients (n = 52 in the amoxicillin group and n = 53 in the placebo group) were evaluated and none were excluded from the study at 3 months. Six post-operative infections occurred and two implants were lost in each group. There were no statistically significant differences for postoperative infection, adverse events, implant failures and the characteristics of saprophytic flora between groups. The use of amoxicillin did not either alter or modify the characteristics of the saprophytic flora nor provoke remarkable side effects.

CONCLUSIONS

Antibiotic prophylaxis may not be needed when placing single implants in patients with bone types II and III.

摘要

目的

比较在II型和III型骨中植入单个种植体时,术前1小时口服2g阿莫西林与服用相同安慰剂片的疗效和安全性。

材料与方法

西班牙12家私立牙科诊所同意参与本试验。共招募了105名患者。患者被随机分为口服2g阿莫西林组或服用相同安慰剂片组。仅纳入需要单个种植体的患者。观察指标为术后感染、不良事件和种植体失败情况。还对所有患者的腐生菌群特征进行了研究。术后3天、10天、1个月和3个月对患者进行随访。

结果

共评估了105名患者(阿莫西林组n = 52,安慰剂组n = 53),3个月时无一例被排除在研究之外。每组均发生6例术后感染,2枚种植体丢失。两组之间在术后感染、不良事件、种植体失败及腐生菌群特征方面无统计学显著差异。使用阿莫西林既未改变腐生菌群的特征,也未引发明显的副作用。

结论

在II型和III型骨患者中植入单个种植体时可能无需预防性使用抗生素。

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