- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02113137
Oral Hygiene Procedures on Reduction of Oral Malodor
Effects of Various Oral Hygiene Procedures on the Reduction of Oral Malodor in Periodontally Healthy Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Tokyo, Japan, 113-8549
- Department of oral health promotion
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical diagnosis of oral malodor
- At least 20 functional teeth
- No systemic diseases
- No severe dental diseases
Exclusion Criteria:
- Habit of smoking and betel quid chewing
- Oral malodor by food and other craniofacial abnormalities
- Current use of any kind of mouthwash
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: group 1: drug
Drug: group 1: drug: chlorine dioxide 12ml chlorine dioxide (ClO2) mouthwash two times per day, for three consecutive weeks
|
First, each group practiced tooth brushing only for one week. After that each group was requested to do the following procedures. group 1 - additional use of 12ml chlorine dioxide (ClO2) mouthwash two times per day, for three consecutive weeks besides tooth brushing. At last, each group practiced all three methods of tooth brushing, tongue cleaning, mouth washing.
Other Names:
|
|
Experimental: group 2: device:
group 2: device: small tooth brush for tongue cleaning small tooth brush for tongue cleaning
|
First, each group practiced tooth brushing only for one week. After that each group was requested to do the following procedures. group 2 - additional practice of tongue cleaning by a small tooth brush two times per day, for three consecutive weeks besides tooth brushing. At last, each group practiced all three methods of tooth brushing, tongue cleaning, mouth washing. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Volatile sulfur compounds (VSCs)
Time Frame: 5 weeks
|
Total volatile sulfur compounds was measured by Breathron®
|
5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bleeding on probing
Time Frame: 5 weeks
|
gingival bleeding was recorded of bleeding was detected after examination with periodontal probe.
|
5 weeks
|
|
Tongue coating
Time Frame: 5weeks
|
tongue coating was evaluated by Winkel tongue coating index.
|
5weeks
|
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Debris index
Time Frame: 5 weeks
|
debris index was evaluated by oral hygiene index.
|
5 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: EiEi Aung, student, Department of oral health promotion
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OHP-018-EI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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