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Clinical and Microbiological Effects of a Mouthwash Containing Chlorine Dioxide

Primary Purpose

Halitosis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Chlorine Dioxide
Sponsored by
Tokyo Medical and Dental University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Halitosis focused on measuring chlorine, dioxide, mouthwash, halitosis, bacteria, saliva

Eligibility Criteria

19 Years - 38 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Clinical diagnosis of oral malodor

Exclusion Criteria:

  • Oral malodor caused by foods

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Oral malodor

    Secondary Outcome Measures

    Periodontal bacteria

    Full Information

    First Posted
    September 8, 2008
    Last Updated
    September 11, 2008
    Sponsor
    Tokyo Medical and Dental University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00748943
    Brief Title
    Clinical and Microbiological Effects of a Mouthwash Containing Chlorine Dioxide
    Official Title
    The Clinical Effects of a Mouthwash Containing Chlorine Dioxide on Oral Malodor and Salivary Periodontal and Malodorous Bacteria Using for 7days
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2007 (undefined)
    Primary Completion Date
    May 2007 (Actual)
    Study Completion Date
    June 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Tokyo Medical and Dental University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Halitosis
    Keywords
    chlorine, dioxide, mouthwash, halitosis, bacteria, saliva

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    Chlorine Dioxide
    Other Intervention Name(s)
    ClO2 Fresh®
    Intervention Description
    Experimental mouthwash (ClO2 Fresh®) contained 0.16% sodium chlorite (NaClO2)
    Primary Outcome Measure Information:
    Title
    Oral malodor
    Time Frame
    7 days
    Secondary Outcome Measure Information:
    Title
    Periodontal bacteria
    Time Frame
    7 days

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    38 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of oral malodor Exclusion Criteria: Oral malodor caused by foods
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kayoko Shinada, DDS,phD
    Organizational Affiliation
    Dept. of Oral health promotion, Tokyo medical and dental university
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20152022
    Citation
    Shinada K, Ueno M, Konishi C, Takehara S, Yokoyama S, Zaitsu T, Ohnuki M, Wright FA, Kawaguchi Y. Effects of a mouthwash with chlorine dioxide on oral malodor and salivary bacteria: a randomized placebo-controlled 7-day trial. Trials. 2010 Feb 12;11:14. doi: 10.1186/1745-6215-11-14.
    Results Reference
    derived

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    Clinical and Microbiological Effects of a Mouthwash Containing Chlorine Dioxide

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