Asepsis During Periodontal Surgery Involving Oral Implants and the Usefulness of Antibiotics: a Prospective, Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Rate of post-operative infection
研究概览
简要总结
Objectives: This randomized clinical trial will compare the usefulness of pre- and postoperative antibiotics while strict asepsis will be followed during periodontal surgery in smokers diagnosed with Stage III Grade C Generalized Periodontitis.
Material and Methods: Two groups of 40 consecutive patients each with fully or partially edentulous jaws will be enrolled. Antibiotics group (GrAB+): will receive oral doxycycline 200 mg, 1 h pre-operatively and 100 mg g for 9 days post-operatively. Non-antibiotics group (GrAB- ): will receive a placebo (no antibiotics). Bacterial samples will be taken from the peri-oral skin before and at the end of the surgery. In 12 patients in each group, samples will also be taken from the nares. A visual analogue scale will evaluate symptoms of infection/ inflammation by both the patient and the periodontist at suture removal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •in need of dental implant therapy
- •above 18 years of age
排除标准
- •allergy to doxycycline,
- •need for endocarditis prophylaxis,
- •any systemic or local immunodeficiency,
- •uncontrolled diabetes mellitus,
- •previous radiation therapy in the head and neck area
结局指标
主要结局
Rate of post-operative infection
时间窗: 7 days
signs of infection (fever \> 38 degrees celsius, spontaneous bleeding, pus, swelling, etc.) post-operatively will be checked at suture removal
次要结局
未报告次要终点
研究者
Mahmoud Abu-Ta'a
Associate Professor
Arab American University (Palestine)