Oral Hygiene Procedures on Reduction of Oral Malodor
Primary Purpose
Halitosis
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
group 1: drug: chlorine dioxide
group 2: device: small tooth brush for tongue cleaning
Sponsored by
About this trial
This is an interventional prevention trial for Halitosis focused on measuring halitosis, chlorine dioxide, tongue cleaning
Eligibility Criteria
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
Sites / Locations
- Department of oral health promotion
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
group 1: drug
group 2: device:
Arm Description
Drug: group 1: drug: chlorine dioxide 12ml chlorine dioxide (ClO2) mouthwash two times per day, for three consecutive weeks
group 2: device: small tooth brush for tongue cleaning small tooth brush for tongue cleaning
Outcomes
Primary Outcome Measures
Volatile sulfur compounds (VSCs)
Total volatile sulfur compounds was measured by Breathron®
Secondary Outcome Measures
Bleeding on probing
gingival bleeding was recorded of bleeding was detected after examination with periodontal probe.
Tongue coating
tongue coating was evaluated by Winkel tongue coating index.
Debris index
debris index was evaluated by oral hygiene index.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02113137
Brief Title
Oral Hygiene Procedures on Reduction of Oral Malodor
Official Title
Effects of Various Oral Hygiene Procedures on the Reduction of Oral Malodor in Periodontally Healthy Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
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
Sponsor-Investigator
Name of the Sponsor
Ei Ei Aung
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to evaluate the effect of various oral hygiene procedures on reduction of oral malodor.
Detailed Description
Thirty volunteers who matched with including criteria were divided randomly into two groups. Both groups were instructed to brush their teeth with a scrubbing method for the first one week. Then, each group received the different additional oral malodor reduction regimen- in addition to tooth brushing tongue cleaning in one group and chlorine dioxide (ClO2) mouthwash in another group for three consecutive weeks. After that, all the participants were instructed to practice all the three oral hygiene procedures (tooth brushing, mouth washing, tongue cleaning) the last one week. Total volatile sulfur compounds (VSCs) measured by breathtron, tongue coating, plaque score and bleeding on probing (BOP) were outcomes of this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Halitosis
Keywords
halitosis, chlorine dioxide, tongue cleaning
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 1: drug
Arm Type
Experimental
Arm Description
Drug: group 1: drug: chlorine dioxide 12ml chlorine dioxide (ClO2) mouthwash two times per day, for three consecutive weeks
Arm Title
group 2: device:
Arm Type
Experimental
Arm Description
group 2: device: small tooth brush for tongue cleaning small tooth brush for tongue cleaning
Intervention Type
Drug
Intervention Name(s)
group 1: drug: chlorine dioxide
Other Intervention Name(s)
ClO2Fresh®
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
group 2: device: small tooth brush for tongue cleaning
Intervention Description
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.
Primary Outcome Measure Information:
Title
Volatile sulfur compounds (VSCs)
Description
Total volatile sulfur compounds was measured by Breathron®
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Bleeding on probing
Description
gingival bleeding was recorded of bleeding was detected after examination with periodontal probe.
Time Frame
5 weeks
Title
Tongue coating
Description
tongue coating was evaluated by Winkel tongue coating index.
Time Frame
5weeks
Title
Debris index
Description
debris index was evaluated by oral hygiene index.
Time Frame
5 weeks
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EiEi Aung, student
Organizational Affiliation
Department of oral health promotion
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of oral health promotion
City
Tokyo
ZIP/Postal Code
113-8549
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
25622725
Citation
Aung EE, Ueno M, Zaitsu T, Furukawa S, Kawaguchi Y. Effectiveness of three oral hygiene regimens on oral malodor reduction: a randomized clinical trial. Trials. 2015 Jan 27;16:31. doi: 10.1186/s13063-015-0549-9.
Results Reference
derived
Learn more about this trial
Oral Hygiene Procedures on Reduction of Oral Malodor
We'll reach out to this number within 24 hrs