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Completed

NCT Number: NCT00748943

Clinical and Microbiological Effects of a Mouthwash Containing Chlorine Dioxide

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.

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Key information

Age range

19 year–38 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of oral malodor

Exclusion criteria

  • Oral malodor caused by foods

Treatment and study plan

chlorine dioxide

Other

Experimental mouthwash (ClO2 Fresh®) contained 0.16% sodium chlorite (NaClO2)

Other names: ClO2 Fresh®

Primary outcomes

  1. Oral malodor

    Time frame: 7 days

Secondary outcomes

  1. Periodontal bacteria

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Tokyo Medical and Dental University

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Sep 9, 2008
Registry last updated
Sep 12, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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