A Clinical Trial to Assess the Effects of a Mouthwash Containing Chlorine Dioxide on Oral Malodor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-04-30

Brief Summary

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A mouthwash containing chlorine dioxide would be effective to reduce oral malodor.

Detailed Description

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A randomized, double blind, crossover, placebo-controlled clinical trial was conducted among 15 healthy male volunteers, who were divided into 2 groups: experimental or control group. In the first test phase, the subjects in the experimental group were instructed to rinse with the mouthwash containing ClO2 and those in the control group with the placebo mouthwash without ClO2. In the second test phase after one week washout period, same procedure was conducted with the opposite mouthwashes. Oral malodor was evaluated at before rinsing, right after rinsing and follows up every 30 minutes till 4 hours with OM, and the concentrations of hydrogen sulfide (H2S), methyl mercaptan (CH3SH) and dimethyl sulfide ((CH3)2S) which are the main volatile sulfur compounds (VSCs) of human oral malodor were evaluated with GC.

Conditions

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Halitosis

Keywords

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chlorine dioxide mouthwash organoleptic measurements volatile sulfur compounds

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Interventions

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Chlorine Dioxide

Experimental mouthwash (ClO2 Fresh®): 0.16% sodium chlorite (NaClO2) with an efficacy of 0.1% chlorine dioxide (ClO2),Placebo mouthwash: glycerin, mint oil and distilled water, contents are almost the same as those in the experimental mouthwash except ClO2.

Intervention Type OTHER

Other Intervention Names

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ClO2 Fresh®

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of oral malodor
* Rinsing the mouthwash

Exclusion Criteria

* oral malodor caused by foods

Minimum Eligible Age

19 Years

Maximum Eligible Age

38 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Dept. of Oral health promotion, Tokyo medical and dental university

Principal Investigators

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Kayoko Shinada, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Oral health promotion, Tokyo medical and dental university

Locations

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Dept. Oral health promotion, Tokyo medical and dental university

Yushima Bunkyo-ku, Tokyo, Japan

Site Status

Countries

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Japan

References

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Shinada K, Ueno M, Konishi C, Takehara S, Yokoyama S, Kawaguchi Y. A randomized double blind crossover placebo-controlled clinical trial to assess the effects of a mouthwash containing chlorine dioxide on oral malodor. Trials. 2008 Dec 9;9:71. doi: 10.1186/1745-6215-9-71.

Reference Type DERIVED

PMID: 19068114 (View on PubMed)

Other Identifiers

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1_Shinada

Identifier Type: -

Identifier Source: org_study_id