Effect of Systemic Antibiotic Therapy on Postoperative Complications in Patients Undergoing Wisdom Teeth Removal Surgery. A Double-blind, Randomised, Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Mouth opening restrictions: Change of interincisal distance
研究概览
简要总结
59 medically healthy patients, who are scheduled for third molar extraction surgery and give informed consent for the trial, are operated using a split-mouth technique.
One group of patients will be assigned to the test group (Amoxilan) for the first surgery and to the control group (placebo) for the second surgery, and vice versa, according to randomisation.
Patients receive 8 capsules Amoxilan or placebo (according to randomisation) perioperatively, and 6 capsules Amoxilan/placebo per day for 3 days postoperativeley.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptom-free, bilaterally located third molars
- •Medically healthy patient ≥ 16 years
- •No allergies/intolerances against the investigational product/placebo
- •Informed consent
排除标准
- •General contraindications to wisdom tooth extraction surgery
- •(Former) heavy smoking
- •Use of antibiotics within the last three months or patients requiring antibiotic treatment prior to surgery
- •(Planned) Pregnancy/lactating
研究组 & 干预措施
Amoxilan
Patients receive 8 capsules Amoxilan perioperatively and for the next 3 days 6 capsules per day.
干预措施: Amoxilan (Drug)
Placebo
Patients receive 8 capsules Placebo perioperatively and for the next 3 days 6 capsules per day.
干预措施: Placebo (Other)
结局指标
主要结局
Mouth opening restrictions: Change of interincisal distance
时间窗: preoperatively as well as on the 1st and 7th postoperative day
Interincisal distance, with maximum mouth opening, is measured with a ruler.
次要结局
- Change of swelling(preoperatively as well as on the 1st and 7th postoperative day)
- Change of Visual Analogue Scale (VAS): Swelling(day of surgery, and on day 1, 2, 3, 4, 5, 6, 7 after surgery)
- Change of Visual Analogue Scale (VAS): Bleeding(day of surgery, and on day 1, 2, 3, 4, 5, 6, 7 after surgery)
- Change of Visual Analogue Scale (VAS): Pain(day of surgery, and on day 1, 2, 3, 4, 5, 6, 7 after surgery)