Comparison of Three Antibiotic Protocols in Prevention of Infection in Dental Implant Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 450
- 主要终点
- Infection incidence
研究概览
简要总结
Subjects who underwent a dental implant surgery were studied.Subjects randomly were aligned into three groups:In group 1, subjects received prophylactic antibiotic orally (Amoxicillin 2mg ,1 hour before surgery) and post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days), subjects received only prophylactic antibiotic (Amoxicillin 2mg ,1 hour before surgery) in group 2 ,and in group 3, subjects received post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days). The sign and symptom of infection were studied and the incidence of infection in each group was determined.
详细描述
Subjects eligible for study inclusion had an edentulous area in the mandible or maxilla and underwent a dental implant surgery. Subjects were excluded from study enrollment if they had systemic diseases which affect bone metabolism, history of allergy to amoxicillin, refused study enrollment or failed to return for follow-up.
Subjects were randomly divided into three groups : In group 1, subjects received prophylactic antibiotic orally (Amoxicillin 2mg ,1 hour before surgery) and post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days), subjects received only prophylactic antibiotic (Amoxicillin 2mg ,1 hour before surgery) in group 2 ,and in group 3, subjects received post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days) . An independent researcher made random allocation cards using computer-generated random. Then, allocated cases were placed in a sealed envelope. All subjects used 0.2% chlorhexidine mouthwash in the treatment period. All implants were placed with a two-stage protocol.
All subjects were followed up for 3 months to assess any infection signs and symptoms. Infection was diagnosed based on clinical findings such as pain, redness of the area, and discharge around the fixture.An independent dentist who was blind the study groups, evaluated all subjects.
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
- Single (Participant)
盲法说明
An independent investigator who was blind to participants (groups) evaluated all subjects
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have an edentulous area in the mandible or maxilla
- •underwent a dental implant surgery
排除标准
- •systemic diseases which affect bone metabolism
- •history of allergy to amoxicillin
- •refused study enrollment
- •failed to return for follow-up.
研究组 & 干预措施
Pre and post op Antibiotic
subjects received prophylactic antibiotic orally (Amoxicillin 2mg ,1 hour before surgery) and post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days)
干预措施: Amoxicillin (Drug)
Pre-op antibiotic
subjects received only prophylactic antibiotic (Amoxicillin 2mg ,1 hour before surgery)
干预措施: Amoxicillin (Drug)
Post-op antibiotic
subjects received post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days)
干预措施: Amoxicillin (Drug)
结局指标
主要结局
Infection incidence
时间窗: 3 months
pain, redness of the area, and discharge around the fixture.
次要结局
未报告次要终点
研究者
RTabrizi
Shiraz university of medical sciences
Shiraz University of Medical Sciences
