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临床试验/ACTRN12617001498381
ACTRN12617001498381已完成4 期

Antibiotic Prophylaxis in the prevention of infectious complications in mandibular impacted third molars extraction: A randomized clinical trial

Facultad de Odontología. Universidad de Chile0 个研究点目标入组 120 人开始时间: 2017年10月24日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
120

研究概览

简要总结

Background: The objective of this study was to determine the effect of antibiotic prophylaxis in preventing postoperative infections after extraction of impacted mandibular third molars. Material and Methods: A Parallel-group, randomized, blind, placebo-controlled trial was performed. 154 patients were randomly allocated to 2 groups; experimental (n=77) receiving 2g amoxicillin 1 hour prior to surgery and control (n=77) receiving placebo. The primary outcome was postoperative infections, and the secondary outcome was the need for rescue analgesia. Results: 4.5% of patients developed postoperative infections, five patients of the control group (4 alveolar osteitis, 1 surgical site infection) and two of the experimental group (1 alveolar osteitis, 1 surgical site infection). The difference between groups was not statistically significant, RR=0.4 (95%CI 0.08-1.99, p=0.41) NNTB=26. Rescue analgesia intake was significantly higher in the control group (41 vs. 18 patients of experimental group) RR=0.49 (95%CI 0.32-0.75, p<0.05) NNTB=3. Conclusions: The use of 2g amoxicillin 1 hour before surgery was not effective in significantly reducing the risk of postoperative infections from impacted mandibular third molars extraction compared to placebo. Nevertheless, antibiotic prophylaxis was associated with a reduced need for rescue analgesia.

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Prevention
盲法
Blinded (masking used)

入排标准

年龄范围
15 Years 至 35 Years(—)
性别
All

入选标准

  • Healthy patients between 15 to 35 years old: Clinically and radiographically presence at least of one impacted mandibular third molar,

排除标准

  • Allergy to penicillin and its derivatives.
  • Allergy to nonsteroidal anti-inflammatory drugs.
  • Patients with gastric ulcer.
  • Patients who have undergone any type of antibiotic treatment at least 30 days before surgery.
  • Patients with pericoronaritis episode up to 7 days before the intervention.
  • Patients with psychiatric illness.
  • Immunocompromised
  • Patients with addiction to narcotic drugs or illicit substances

研究者

发起方
Facultad de Odontología. Universidad de Chile

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