HalitosisPhase 4NCT02113137
Oral Hygiene Procedures on Reduction of Oral Malodor
A Phase 4 study testing group 1: drug: chlorine dioxide and group 2: device: small tooth brush for tongue cleaning in people with Halitosis, run by Ei Ei Aung at 1 site in Japan.
Trial summary
The purpose of the study is to evaluate the effect of various oral hygiene procedures on reduction of oral malodor. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Halitosis
- What is being tested?
- group 1: drug: chlorine dioxide and group 2: device: small tooth brush for tongue cleaning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2013to Nov 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinical diagnosis of oral malodor
- At least 20 functional teeth
- No systemic diseases
- No severe dental diseases
Who cannot join
- Habit of smoking and betel quid chewing
- Oral malodor by food and other craniofacial abnormalities
- Current use of any kind of mouthwash
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Various Oral Hygiene Procedures on the Reduction of Oral Malodor in Periodontally Healthy Patients
The purpose of the study is to evaluate the effect of various oral hygiene procedures on reduction of oral malodor.
Read the 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.
- Conditions
- Halitosis
- Being tested
- group 1: drug: chlorine dioxide, group 2: device: small tooth brush for tongue cleaning
- Keywords
- halitosis, chlorine dioxide, tongue cleaning
- Medical subject headings
- Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group 1: drug: chlorine dioxideDrug
Also called ClO2Fresh®
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.
group 2: device: small tooth brush for tongue cleaningDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| group 1: drug | Experimental | Drug: group 1: drug: chlorine dioxide 12ml chlorine dioxide (ClO2) mouthwash two times per day, for three consecutive weeks Receives: Drug: group 1: drug: chlorine dioxide |
| group 2: device: | Experimental | group 2: device: small tooth brush for tongue cleaning small tooth brush for tongue cleaning Receives: Device: group 2: device: small tooth brush for tongue cleaning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volatile sulfur compounds (VSCs)
Total volatile sulfur compounds was measured by Breathron®
Measured: 5 weeks
Secondary outcomes (3)
Bleeding on probing
gingival bleeding was recorded of bleeding was detected after examination with periodontal probe.
Measured: 5 weeks
Tongue coating
tongue coating was evaluated by Winkel tongue coating index.
Measured: 5weeks
Debris index
debris index was evaluated by oral hygiene index.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startSep 2013
- Primary completionOct 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HalitosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ei Ei Aung
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ei Ei Aung, Tokyo Medical and Dental University
- Investigators
- EiEi Aung, student, Principal investigator, Department of oral health promotion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113137
- Sponsor's protocol ID
- OHP-018-EI
- Status last verified
- Apr 2014
- First submitted
- 7 Apr 2014
- Last updated
- 14 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25622725
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Various Oral Hygiene Procedures on the Reduction of Oral Malodor in Periodontally Healthy Patients
- ClinicalTrials.gov ID
- NCT02113137
- Acronym / sponsor ID
- OHP-018-EI
- Conditions
- Halitosis
- Keywords
- halitosis, chlorine dioxide, tongue cleaning
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ei Ei AungUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 14 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1: drug | Experimental | Drug: group 1: drug: chlorine dioxideDrug: group 1: drug: chlorine dioxide 12ml chlorine dioxide (ClO2) mouthwash two times per day, for three consecutive weeks |
| group 2: device: | Experimental | Device: group 2: device: small tooth brush for tongue cleaninggroup 2: device: small tooth brush for tongue cleaning small tooth brush for tongue cleaning |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of oral malodor
- At least 20 functional teeth
- No systemic diseases
- No severe dental diseases
Key exclusion criteria (3 listed)
- Habit of smoking and betel quid chewing
- Oral malodor by food and other craniofacial abnormalities
- Current use of any kind of mouthwash
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| group 1: drug: chlorine dioxideAlso: ClO2Fresh®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. | Drug | group 1: drug |
| group 2: device: small tooth brush for tongue cleaningFirst, 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. | Device | group 2: device: |
Primary outcome
Volatile sulfur compounds (VSCs)
Time frame: 5 weeks
Total volatile sulfur compounds was measured by Breathron®
3 secondary outcomes
Bleeding on probing
Time frame: 5 weeks
Tongue coating
Time frame: 5weeks
Debris index
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2014.
- Derived from this study: PubMed 25622725Aung 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EiEi Aung, student principal investigator
Department of oral health promotion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing group 1: drug: chlorine dioxide and group 2: device: small tooth brush for tongue cleaning in people with Halitosis, run by Ei Ei Aung at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volatile sulfur compounds (VSCs) (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02113137, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2014.