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临床试验/NCT02375178
NCT02375178已完成不适用

Antimicrobial Activity of Two Mouthwashes

Universidade do Vale do Sapucai0 个研究点目标入组 30 人开始时间: 2014年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
主要终点
Number of Colony Forming Units

研究概览

简要总结

This is a three arm randomized trial. The aim is to evaluate the antimicrobial activity of chlorhexidine and polyhexamethylene biguanide oral antiseptics on the microorganisms of the oral cavity. A total of 30 healthy volunteers will be enrolled and randomly allocated to control group (CG, n=10), which will be instructed to rinse the mouth with 10ml of a sterile saline solution for one minute, to chlorhexidine group (ClG, n=10), which will be instructed to rinse the mouth with 10ml of an 0.12% chlorhexidine solution, for one minute, or to polyhexamethylene biguanide group (PG, n=10), which will be instructed to rinse the mouth with 10ml of an 0.07% polyhexamethylene biguanide solution, for one minute. Samples of saliva will be collected before the mouth wash and after 30, 60 and 180 minutes. Samples will be plated on manitol agar, mitis salivarius agar, EMB agar and Sabouraud agar. Samples will be processed by a blinded microbiologist.

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
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 aged 18-30 years

排除标准

  • patients with a hypersensitivity or allergic response by some component of the formula antiseptics,
  • pregnant women,
  • lactating,
  • history of periodontal disease,
  • decompensated diabetics,
  • patients undergoing chemotherapy,
  • radiotherapy patient,
  • transplanted patient and refuses to participate,
  • not signing a term of free and informed concentiment

研究组 & 干预措施

Sterile saline solution

Active Comparator

sterile Saline solution 0,9%

干预措施: Sterile saline solution (Drug)

chlorhexidine

Experimental

chlorhexidine 0,12% mouthwash

干预措施: chlorhexidine (Drug)

chlorhexidine

Experimental

chlorhexidine 0,12% mouthwash

干预措施: Sterile saline solution (Drug)

polyhexamethylene

Experimental

polyhexamethylene biguanide 0,07% mouthwash

干预措施: Polyhexamethylene biguanide (Drug)

polyhexamethylene

Experimental

polyhexamethylene biguanide 0,07% mouthwash

干预措施: Sterile saline solution (Drug)

结局指标

主要结局

Number of Colony Forming Units

时间窗: 180 minutes

Samples of saliva will be collected before the mouth wash and after 30, 60 and 180 minutes.

次要结局

未报告次要终点

研究者

发起方
Universidade do Vale do Sapucai
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fernanda Sebba de Souza

student

Universidade do Vale do Sapucai

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