术前单次给予抗生素对早期种植体失败率的影响。一项随机临床试验。

Influence of a single preoperative dose of antibiotics on the early implant failure rate. A randomized clinical trial.

机构信息

Faculty of Odontology, Department of Oral & Maxillofacial Surgery, University of Göteborg, Gothenburg, Sweden.

The Brånemark Clinic, Public Dental Health Service, Västra Götaland, Sweden.

出版信息

Clin Implant Dent Relat Res. 2019 Apr;21(2):278-283. doi: 10.1111/cid.12724. Epub 2019 Mar 5.

DOI:10.1111/cid.12724

PMID:30838799

Abstract

BACKGROUND

The use of a preoperative single dose of antibiotics as routine in conjunction with implant surgery is controversial, in light of the unclear effect on early implant failure rate and risk for development of resistant bacterial strains.

PURPOSE

This randomized clinical trial compared the early implant failure rates in two different patient cohorts: One group receiving a single dose of preoperative antibiotics (AB group) and one group receiving no antibiotics, prior to implant surgery (noAB group).

MATERIALS AND METHODS

Patients were referred for treatment at four specialist clinics in the county council of West Sweden, Vastra Gotaland and randomly assigned into one of the two groups. A total of 447 patients received 963 implants were included in the study. Of these, 223 patients (535 implants) belonged to the AB-group and 224 patients (428 implants) to the noAB-group. Four commercial implant brands were utilized, albeit one system was only represented with four implants. The outcome was evaluated after 4 months using either a one-stage or two-stage procedure. The surgical procedures were performed by experienced implant surgeons and the surgical protocol for implant placement follows standard. Failure was defined as removal of an implant for any reason. The study outcomes were statistically analyzed to evaluate the differences between the two groups.

RESULTS

Twelve implants failed in 11 patients for the AB group, and 32 implants failed in 29 patients for the noAB group. Preoperative antibiotics, AB group, had significantly (P < 0.0011) lower implant failure 2.2% compared to 7.5% in the noAB group analyzed on implant level adjusted for dependence within patients, OR = 0.30, 95% confidence interval (0.14-0.62).

CONCLUSION

Administration of a single dose of antibiotics in conjunction with implant placement surgery resulted in a statistically significant lower early implant failure rate compared to when no antibiotics were used.

摘要

背景

术前单次使用抗生素作为常规治疗与种植体手术相结合，其对早期种植体失败率和耐药菌形成风险的影响并不明确，因此存在争议。

目的

本随机临床试验比较了两组不同患者的早期种植体失败率：一组患者在种植手术前接受单次剂量的抗生素（AB 组），另一组患者（noAB 组）在种植手术前不使用抗生素。

材料和方法

患者来自瑞典西约塔兰省韦斯特罗斯市的四个专科诊所，随机分配到两组中的一组。共有 447 名患者接受了 963 枚种植体的治疗，其中 223 名患者（535 枚种植体）属于 AB 组，224 名患者（428 枚种植体）属于 noAB 组。使用了四个商业种植体品牌，尽管其中一个系统仅代表了 4 枚种植体。术后 4 个月采用一期或二期手术进行评估。手术由经验丰富的种植体外科医生进行，种植体放置的手术方案遵循标准。因任何原因移除种植体即视为失败。对研究结果进行了统计学分析，以评估两组之间的差异。

结果

AB 组 11 名患者中有 12 枚种植体失败，noAB 组 29 名患者中有 32 枚种植体失败。AB 组（术前使用抗生素）的种植体失败率明显（P < 0.0011）低于 7.5%，而 noAB 组（未使用抗生素）的种植体失败率为 2.2%，经患者内相关性调整后，OR=0.30，95%置信区间（0.14-0.62）。