Back to resultsThree 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
About this trial
This is an interventional prevention trial for Halitosis
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
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
NCT ID
NCT02689297
First Posted
February 8, 2016
Last Updated
February 18, 2016
Sponsor
Tokyo Medical and Dental University
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
Learn more about this trial
Three Different Oral Hygiene Regimes on Three Volatile Sulfur Compounds
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