HalitosisPhase 4NCT02689297
Three Different Oral Hygiene Regimes on Three Volatile Sulfur Compounds
A Phase 4 study testing chlorine dioxide and small toothbrush for tongue cleaning in people with Halitosis, run by Tokyo Medical and Dental University.
Trial summary
The purpose of the study is to evaluate the effect of various oral hygiene regimes on three volatile sulfur compounds. 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?
- chlorine dioxide and small toothbrush for tongue cleaning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- 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
- No systemic diseases and no severe dental diseases
- At least 20 functional teeth
Who cannot join
- Risky oral habit (smoking and betel quid chewing)
- Current use of antibiotics or any drugs
- Current use of any kind of mouthwash
About this study
The purpose of the study is to evaluate the effect of various oral hygiene regimes on three volatile sulfur compounds.
Read the 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.
- Conditions
- Halitosis
- Being tested
- chlorine dioxide, small toothbrush for 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.
chlorine dioxideOther
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.
small toothbrush for tongue cleaningOther
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.
| Study group | Role | What they receive |
|---|---|---|
| group A | Other | Mouthwash (chlorine dioxide 12ml two times per day, for three weeks) Receives: Other: chlorine dioxide |
| group B | Other | Small toothbrush for tongue cleaning two times per day for three weeks Receives: Other: small toothbrush for tongue cleaning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 5weeks
Secondary outcomes (4)
Oral Health examination
As oral examination, investigator examined present teeth, DMF-T (decayed, missing and filled teeth)
Measured: up to 5weeks
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.
Measured: up to 5weeks
Number of teeth with bleeding on probing
Measured: up to 5weeks
Plaque index score
Measured: up to 5weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (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.
- 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
- Tokyo Medical and Dental University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ei Ei Aung, Tokyo Medical and Dental University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689297
- Sponsor's protocol ID
- OHP-018-EI-2
- Status last verified
- Feb 2016
- First submitted
- 8 Feb 2016
- Last updated
- 23 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Different Oral Hygiene Regimes on Three Volatile Sulfur Compounds
- ClinicalTrials.gov ID
- NCT02689297
- Acronym / sponsor ID
- OHP-018-EI-2
- Conditions
- Halitosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tokyo Medical and Dental UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 23 Feb 2016 (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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Other | Other: chlorine dioxideMouthwash (chlorine dioxide 12ml two times per day, for three weeks) |
| group B | Other | Other: small toothbrush for tongue cleaningSmall toothbrush for tongue cleaning two times per day for three weeks |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of oral malodor
- No systemic diseases and no severe dental diseases
- At least 20 functional teeth
Key exclusion criteria (3 listed)
- Risky oral habit (smoking and betel quid chewing)
- Current use of antibiotics or any drugs
- 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 |
|---|---|---|
| chlorine dioxideFirst 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. | Other | group A |
| small toothbrush for tongue cleaningFirst 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. | Other | group B |
Primary outcome
Three different volatile sulfur compounds
Time frame: up to 5weeks
Investigator measured three different volatile sulfur compounds: hydrogen sulfide, methyl mercaptan, dimethyl sulfide concentrations (ng/10ml) by using Oral chroma.
4 secondary outcomes
Oral Health examination
Time frame: up to 5weeks
Tongue coating characteristics
Time frame: up to 5weeks
Number of teeth with bleeding on probing
Time frame: up to 5weeks
Plaque index score
Time frame: up to 5weeks
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 23 Feb 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing chlorine dioxide and small toothbrush for tongue cleaning in people with Halitosis, run by Tokyo Medical and Dental University.
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 3 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 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Three different volatile sulfur compounds (time frame: up to 5weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2016.