A Comparison of Single Preoperative Dose of Co-amoxiclav Versus Postoperative Full Course of Amoxicillin/ Co-amoxiclav in Prevention of Postoperative Complications in Dentoalveolar Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- infection rate
研究概览
简要总结
There was no evidence to judge the effects of preventative antibiotics for extractions of severely decayed teeth, teeth in diseased gums, or extractions in patients who are sick or have low immunity to infection. Undertaking research in these groups of people may not be possible or ethical. However, it is likely that in situations where patients are at a higher risk of infection that preventative antibiotics may be beneficial, because infections in this group are likely to be more frequent and more difficult to treat To the best of knowledge, no adult study has compared the effects of single dose of Co-Amoxiclave and full oral course before or after dentoalveolar surgery. The current study has formally considered this comparison as a potential valuable trail for reducing the postoperative complications in adult patients who have had surgical removal of teeth under LA.
详细描述
A comparison of single preoperative dose of Co-amoxiclav versus postoperative full course of Amoxicillin/ Co-amoxiclav in prevention of postoperative complications in dentoalveolar surgery: a randomized controlled trial
Background considerations Prophylactic antibiotics and corticoid in a single dose regimen did not bring any benefit on mandibular third molar surgeries.
Tooth extraction is a surgical treatment to remove teeth that are affected by decay or gum disease or impacted wisdom teeth or those causing pain or inflammation.
The risk of infection after extracting wisdom teeth from healthy young people is about 10%; however, it may be up to 25% in patients who are already sick or have low immunity. Infectious complications include swelling, pain, pus drainage, fever, and also dry socket. Treatment of these infections is generally simple and involves patients receiving antibiotics and drainage of infection from the wound.
A review study was carried out to investigate the effectiveness of Antibiotics to prevent complications following tooth extractions. The findings revealed that there is evidence that prophylactic antibiotics reduce the risk of infection, dry socket and pain following third molar extraction and result in an increase in mild and transient adverse effects. However, patients at a higher risk of infection are more likely to benefit from prophylactic antibiotics, because infections in this group are likely to be more frequent, associated with complications and be more difficult to treat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient age from 16 to 70 yrs old
- •Patient needs surgical teeth extraction (subject tooth will be removed using osteotomy by motorised drill).
排除标准
- •Patients refusing the preoperative dose of oral co-amoxiclav, and unwilling to take part .
- •Patients who are allergic to co-amoxiclve, amoxicillin or metronidazole
- •Patient are on warfarin medication
研究组 & 干预措施
Co-Amoxiclav postoperatively alone
• Treatment 1: 0.9% normal saline irrigation immediately after the surgery with course of Co-Amoxiclav 625 mg 0.2% chlorhexidine mouthwash following the surgery for 5 days (control group)
干预措施: Co-Amoxiclav (Drug)
Co-Amoxiclav postoperatively alone
• Treatment 1: 0.9% normal saline irrigation immediately after the surgery with course of Co-Amoxiclav 625 mg 0.2% chlorhexidine mouthwash following the surgery for 5 days (control group)
干预措施: Chlorhexidine mouthwash (Drug)
Co-Amoxiclav postoperatively alone
• Treatment 1: 0.9% normal saline irrigation immediately after the surgery with course of Co-Amoxiclav 625 mg 0.2% chlorhexidine mouthwash following the surgery for 5 days (control group)
干预措施: Normal saline (Drug)
Co-Amoxiclav preoperatively with Metronidazole postoperatively
• Treatment 2: 625 mg Co-Amoxiclav and 1g Paracetamol preoperatively and 0.2% chlorhexidine mouthwash immediately before the surgery with course of Metronidazole 500 mg and 0.2% chlorhexidine mouthwash following the surgery for 5 days
干预措施: Co-Amoxiclav (Drug)
Co-Amoxiclav preoperatively with Metronidazole postoperatively
• Treatment 2: 625 mg Co-Amoxiclav and 1g Paracetamol preoperatively and 0.2% chlorhexidine mouthwash immediately before the surgery with course of Metronidazole 500 mg and 0.2% chlorhexidine mouthwash following the surgery for 5 days
干预措施: Paracetamol (Drug)
Co-Amoxiclav preoperatively with Metronidazole postoperatively
• Treatment 2: 625 mg Co-Amoxiclav and 1g Paracetamol preoperatively and 0.2% chlorhexidine mouthwash immediately before the surgery with course of Metronidazole 500 mg and 0.2% chlorhexidine mouthwash following the surgery for 5 days
干预措施: Chlorhexidine mouthwash (Drug)
Co-Amoxiclav preoperatively with Metronidazole postoperatively
• Treatment 2: 625 mg Co-Amoxiclav and 1g Paracetamol preoperatively and 0.2% chlorhexidine mouthwash immediately before the surgery with course of Metronidazole 500 mg and 0.2% chlorhexidine mouthwash following the surgery for 5 days
干预措施: Normal saline (Drug)
Co-Amoxiclav preoperatively with Metronidazole postoperatively
• Treatment 2: 625 mg Co-Amoxiclav and 1g Paracetamol preoperatively and 0.2% chlorhexidine mouthwash immediately before the surgery with course of Metronidazole 500 mg and 0.2% chlorhexidine mouthwash following the surgery for 5 days
干预措施: Metronidazole (Drug)
Co-Amoxiclav preoperatively with amoxicillin postoperatively
• Treatment 3: 625 mg Co-Amoxiclav and 1g Paracetamol preoperatively and 0.2% chlorhexidine mouthwash immediately before the surgery with course of amoxicillin 500 mg and 0.2% chlorhexidine mouthwash following the surgery for 5 days
干预措施: Co-Amoxiclav (Drug)
Co-Amoxiclav preoperatively with amoxicillin postoperatively
• Treatment 3: 625 mg Co-Amoxiclav and 1g Paracetamol preoperatively and 0.2% chlorhexidine mouthwash immediately before the surgery with course of amoxicillin 500 mg and 0.2% chlorhexidine mouthwash following the surgery for 5 days
干预措施: Paracetamol (Drug)
Co-Amoxiclav preoperatively with amoxicillin postoperatively
• Treatment 3: 625 mg Co-Amoxiclav and 1g Paracetamol preoperatively and 0.2% chlorhexidine mouthwash immediately before the surgery with course of amoxicillin 500 mg and 0.2% chlorhexidine mouthwash following the surgery for 5 days
干预措施: Chlorhexidine mouthwash (Drug)
Co-Amoxiclav preoperatively with amoxicillin postoperatively
• Treatment 3: 625 mg Co-Amoxiclav and 1g Paracetamol preoperatively and 0.2% chlorhexidine mouthwash immediately before the surgery with course of amoxicillin 500 mg and 0.2% chlorhexidine mouthwash following the surgery for 5 days
干预措施: Normal saline (Drug)
Co-Amoxiclav preoperatively with amoxicillin postoperatively
• Treatment 3: 625 mg Co-Amoxiclav and 1g Paracetamol preoperatively and 0.2% chlorhexidine mouthwash immediately before the surgery with course of amoxicillin 500 mg and 0.2% chlorhexidine mouthwash following the surgery for 5 days
干预措施: Amoxicillin 500 Mg (Drug)
结局指标
主要结局
infection rate
时间窗: 5 days after extraction assessment
dry socket after surgical extraction
次要结局
未报告次要终点
研究者
Giath Gazal
Associate Professor
Taibah University