Evaluation of the Effect of Antibiotic Prophylaxis on Inflammatory Factor in Salivary Samples After Third Molars Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Pain reported by patients
研究概览
简要总结
This clinical trial aims to evaluate the impact of antibiotics on inflammation and pain in patients who have undergone mandibular third molar surgery. The primary research questions are:
- Do antibiotics reduce pain following third molar surgery?
- Do antibiotics influence facial swelling and the patient's ability to open their mouth?
- Do antibiotics affect the levels of a specific inflammatory marker in saliva post-surgery?
Participants will be randomly assigned to receive either antibiotic capsules or placebo capsules. The study will include the following procedures:
Medication: Participants will take four capsules (either antibiotics or placebo) as part of their standard surgical care.
Saliva Samples: Saliva samples will be collected at three time points: before surgery, 24 hours after surgery, and 7 days post-surgery.
Measurements: Facial swelling and mouth opening will be assessed by the investigator at each time point.
By comparing the outcomes between the antibiotic and placebo groups, researchers aim to determine the effectiveness of antibiotics in managing post-surgical inflammation and pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy people (ASA I & II)
- •Older than 18 years
- •No history of viral or microbial diseases during the last four months
- •No history of allergic reaction to penicillin-class antibiotics or other drugs that will be used during the research
- •No history of anti-inflammatory or contraceptive drugs use during the last month
- •Not being in pregnancy or nursing period for women
- •Having at least one unerupted mandibular wisdom tooth needs surgical intervention
排除标准
- •History of dental pain, inflammation, or abscess during the last month
- •thyroid hormone therapy
- •unwillingness to participate in the study.
研究组 & 干预措施
intervention group (Antibiotic)
4 amoxicillin 500 mg capsules (2 grams)
干预措施: Amoxicillin (Drug)
Control group (Placebo)
4 empty amoxicillin 500mg capsules
干预措施: Placebo (Drug)
结局指标
主要结局
Pain reported by patients
时间窗: From the first visit immediately after surgery to the last visit, 6 days.
Pain levels are assessed using a Visual Analog Scale (VAS) and a 10-point scale at several intervals: immediately after surgery, at 6 hours, 12 hours, and 24 hours post-surgery, and daily at 17:00 until the 6th day post-surgery. On this scale, 0 indicates no pain, while 10 represents the worst pain the patient has ever experienced.
次要结局
- Maximum mouth opening change(From the initial visit before surgery to the final visit 7 days post-surgery, at 7 days)
- Facial swelling(From the day of surgery to the last visit, at 7 days)
研究者
Carlos Pérez-Albacete Martínez
Prof. Dr.
Universidad Católica San Antonio de Murcia