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临床试验/NCT04620018
NCT04620018已完成不适用

Comparison of Three Antibiotic Protocols in Prevention of Infection in Dental Implant Surgery

Shiraz University of Medical Sciences0 个研究点目标入组 450 人开始时间: 2016年9月30日最近更新:
适应症
干预措施

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

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

Active Comparator

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

Active Comparator

subjects received only prophylactic antibiotic (Amoxicillin 2mg ,1 hour before surgery)

干预措施: Amoxicillin (Drug)

Post-op antibiotic

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

RTabrizi

Shiraz university of medical sciences

Shiraz University of Medical Sciences

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