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