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临床试验/NCT02001311
NCT02001311Unknown1 期

Effect of Chlorhexidine Gel on Bacterial Count and Orthodontic Brackets During Fixed Orthodontic Treatment; In-vivo & In-vitro Study

King Abdulaziz University0 个研究点目标入组 20 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
入组人数
20
主要终点
mutants streptococcus count

研究概览

简要总结

This study investigates the benefit of using chlorhexidine gel as an antimicrobial agent in orthodontic patient to reduce caries risk and the possible consequential effect of this use on the orthodontic brackets used for the treatment.

The investigators hypothesis is that chlorhexidine gel use can reduce caries risk in orthodontic patients with out causing damage to the bonded ceramic or metal orthodontic brackets.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients' age range from 18-30 years.
  • Fixed orthodontic treatment.
  • All the patients are at the end of leveling and alignment stage.
  • Initial bacterial count indicates high caries risk.
  • All patients will be given good oral hygiene instruction at the first visit.
  • The subjects had not taken antibiotics for at least 6 weeks before saliva sampling or during the experimental period.
  • All subjects used a fluoride dentifrice twice a day.

排除标准

  • Patients' age more or less then the age range specified.
  • Removable orthodontic treatment.
  • Patients at early stages of leveling and alignment.
  • Initial bacterial count indicates low caries risk.
  • Subjects that have taken antibiotics for at least 6 weeks before saliva sampling.

研究组 & 干预措施

chlorhexidine gel

Experimental

anti microbial agent that prevents the formation of plaque and reduces caries risk

干预措施: Chlorhexidine gluconate (Drug)

结局指标

主要结局

mutants streptococcus count

时间窗: 48 hours

measures the change in bacterial count before and after application of the gel

次要结局

  • friction(2 minutes)

研究者

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

Dr. Samar Al-Bazi

Doctor

King Abdulaziz University

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