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临床试验/NCT00748943
NCT00748943已完成1 期

The Clinical Effects of a Mouthwash Containing Chlorine Dioxide on Oral Malodor and Salivary Periodontal and Malodorous Bacteria Using for 7days

Tokyo Medical and Dental University0 个研究点目标入组 15 人开始时间: 2007年3月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
15
主要终点
Oral malodor

研究概览

简要总结

Previous research has shown the oxidizing properties and microbiological efficacies of chlorine dioxide (ClO2). However, no clinical studies have investigated its microbiological efficacies on periodontal and malodorous bacteria. The aim of this study was to assess the inhibitory effects of a mouthwash containing ClO2 on morning oral malodor and on salivary periodontal and malodorous bacteria using for 7 days.

详细描述

Background: Previous research has shown the oxidizing properties and microbiological efficacies of chlorine dioxide (ClO2). Its clinical efficacies on oral malodor have been evaluated and reported, however, no clinical studies have investigated its microbiological efficacies on periodontal and malodorous bacteria. The aim of this study was to assess the inhibitory effects of a mouthwash containing ClO2 on morning oral malodor and on salivary periodontal and malodorous bacteria using for 7 days.

Methods: A randomized, double blind, crossover, placebo-controlled clinical trial was conducted among 15 healthy male volunteers, who were divided into 2 groups. In the first test phase, the group 1 subjects (N = 8) were instructed to rinse with the experimental mouthwash containing ClO2 twice per day for 7 days, and those in group 2 (N = 7) to rinse with the control (placebo) mouthwash without ClO2. In the second test, phase after a one week washout period, each group had used the opposite mouthwash for 7 days. At baseline and after 7 days, oral malodor was evaluated with OM, and concentrations of hydrogen sulfide (H2S), methyl mercaptan (CH3SH) and dimethyl sulfide ((CH3)2S), the main VSCs of human oral malodor, were evaluated with GC. Clinical outcome variables included plaque and gingival indices, and the Winkel Tongue Coating Index(WTCI). The samples of saliva were microbiologically investigated.

Outcome variables were compared by t-test and Mann-Whitney test.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 38 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Clinical diagnosis of oral malodor

排除标准

  • Oral malodor caused by foods

结局指标

主要结局

Oral malodor

时间窗: 7 days

次要结局

  • Periodontal bacteria(7 days)

研究者

申办方类型
Other

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