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

Overview

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

Full Title of Study: “A Randomized, Double Blind, Crossover, Placebo-Controlled Clinical Trial to Assess the Effects of a Mouthwash Containing Chlorine Dioxide on Oral Malodor”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: March 2007

Detailed Description

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.

Interventions

  • Other: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Oral malodor was evaluated at before rinsing, right after rinsing and follows up every 30 minutes till 4 hours with organoleptic measurements.
    • Time Frame: 4 hours

Secondary Measures

  • Oral malodor was evaluated at before rinsing, right after rinsing and follows up every 30 minutes till 4 hours with the concentrations of 3 kinds gases of human oral malodor analyzing with gas chromatography.
    • Time Frame: 4 hours

Participating in This Clinical Trial

Inclusion Criteria

  • Clinical diagnosis of oral malodor – Rinsing the mouthwash Exclusion Criteria:

  • oral malodor caused by foods

Gender Eligibility: Male

Minimum Age: 19 Years

Maximum Age: 38 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Tokyo Medical and Dental University
  • Provider of Information About this Clinical Study
    • Kayoko Shinada/DDS, PhD, Dept. of Oral health promotion, Tokyo medical and dental university
  • Overall Official(s)
    • Kayoko Shinada, DDS, PhD, Principal Investigator, Dept. of Oral health promotion, Tokyo medical and dental university

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