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Three Different Oral Hygiene Regimes on Three Volatile Sulfur Compounds

Primary Purpose

Halitosis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
chlorine dioxide
small toothbrush for tongue cleaning
Sponsored by
Tokyo Medical and Dental University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Halitosis

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Clinical diagnosis of oral malodor
  • No systemic diseases and no severe dental diseases
  • At least 20 functional teeth

Exclusion Criteria:

  • Risky oral habit (smoking and betel quid chewing)
  • Current use of antibiotics or any drugs
  • Current use of any kind of mouthwash

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    group A

    group B

    Arm Description

    Mouthwash (chlorine dioxide 12ml two times per day, for three weeks)

    Small toothbrush for tongue cleaning two times per day for three weeks

    Outcomes

    Primary Outcome Measures

    Three different volatile sulfur compounds
    Investigator measured three different volatile sulfur compounds: hydrogen sulfide, methyl mercaptan, dimethyl sulfide concentrations (ng/10ml) by using Oral chroma.

    Secondary Outcome Measures

    Oral Health examination
    As oral examination, investigator examined present teeth, DMF-T (decayed, missing and filled teeth)
    Tongue coating characteristics
    As tongue coating characteristics, investigator examined tongue coating score (by using winkle tongue coating index) at the baseline, one week later, four weeks later and five weeks later.
    Number of teeth with bleeding on probing
    Plaque index score

    Full Information

    First Posted
    February 8, 2016
    Last Updated
    February 18, 2016
    Sponsor
    Tokyo Medical and Dental University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02689297
    Brief Title
    Three Different Oral Hygiene Regimes on Three Volatile Sulfur Compounds
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2013 (undefined)
    Primary Completion Date
    October 2013 (Actual)
    Study Completion Date
    November 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tokyo Medical and Dental University

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of the study is to evaluate the effect of various oral hygiene regimes on three volatile sulfur compounds.
    Detailed Description
    Thirty male monk volunteers who matched with the including criteria were divided randomly into two groups. Both groups were practiced to brush their teeth with scrubbing method for one week. Then, each group were instructed to do different additional protocol regimen- group A have to do mouth washing and tooth brushing and group B have to practice tongue cleaning addition to tooth brushing for three weeks. At the fifth week, both groups were instructed to practice tooth brushing, mouth washing and tongue cleaning. Three different volatile sulfur compounds were measured by oral chroma. Tongue characteristics, oral examination were checked as the outcomes of this study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Halitosis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    group A
    Arm Type
    Other
    Arm Description
    Mouthwash (chlorine dioxide 12ml two times per day, for three weeks)
    Arm Title
    group B
    Arm Type
    Other
    Arm Description
    Small toothbrush for tongue cleaning two times per day for three weeks
    Intervention Type
    Other
    Intervention Name(s)
    chlorine dioxide
    Intervention Description
    First week, subjects were instructed to do regular tooth brushing. After that group A was requested to use chlorine dioxide mouthwash two time per days for three weeks in addition to tooth brushing and then, one week for combination of tooth brushing, tongue cleaning and mouth washing.
    Intervention Type
    Other
    Intervention Name(s)
    small toothbrush for tongue cleaning
    Intervention Description
    First week, subjects were instructed to do regular tooth brushing. After that group B was requested to brush their tongue with small toothbrush two time per days for three weeks in addition to tooth brushing and then, one week for combination of tooth brushing, tongue cleaning and mouth washing.
    Primary Outcome Measure Information:
    Title
    Three different volatile sulfur compounds
    Description
    Investigator measured three different volatile sulfur compounds: hydrogen sulfide, methyl mercaptan, dimethyl sulfide concentrations (ng/10ml) by using Oral chroma.
    Time Frame
    up to 5weeks
    Secondary Outcome Measure Information:
    Title
    Oral Health examination
    Description
    As oral examination, investigator examined present teeth, DMF-T (decayed, missing and filled teeth)
    Time Frame
    up to 5weeks
    Title
    Tongue coating characteristics
    Description
    As tongue coating characteristics, investigator examined tongue coating score (by using winkle tongue coating index) at the baseline, one week later, four weeks later and five weeks later.
    Time Frame
    up to 5weeks
    Title
    Number of teeth with bleeding on probing
    Time Frame
    up to 5weeks
    Title
    Plaque index score
    Time Frame
    up to 5weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of oral malodor No systemic diseases and no severe dental diseases At least 20 functional teeth Exclusion Criteria: Risky oral habit (smoking and betel quid chewing) Current use of antibiotics or any drugs Current use of any kind of mouthwash

    12. IPD Sharing Statement

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    Three Different Oral Hygiene Regimes on Three Volatile Sulfur Compounds

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