HalitosisNCT06890104
Effects of Mechanical, Chemical, and Combination Methods on Halitosis
A study testing Mouthrinse with Coconut oil pulling and Mouthrinse with Chlorhexidine 0.12% in people with Halitosis, run by Hue University of Medicine and Pharmacy at 1 site in Vietnam.
Trial summary
Goal: The goal of this clinical trial is to evaluate the effectiveness of different oral hygiene methods (tooth brushing, tongue cleaning, and mouthwash use) in managing halitosis (bad breath) in adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Halitosis
- What is being tested?
- Mouthrinse with Coconut oil pulling and Mouthrinse with Chlorhexidine 0.12%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteVietnam
- Study dates
- 16 Mar 2024to 30 Aug 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: Participants must be 18 years or older.
- Diagnosis of Halitosis:
- Clinically diagnosed halitosis with an Organoleptic Test (OT) score ≥ 2, AND
- Volatile sulfur compound (VSC) levels exceeding:
- Hydrogen sulfide (H2S) > 1.5 ng/10 ml, OR Methyl mercaptan (CH3SH) > 0.5 ng/10 ml.
- Study Population: Buddhist monks and nuns from selected temples in Hue City, Vietnam, to control for dietary and lifestyle factors.
- Willingness to Participate: Participants must provide informed consent and agree to follow the study protocol.
Who cannot join
- Systemic Diseases: Presence of systemic conditions such as diabetes, gastrointestinal disorders, respiratory disorders, or cancer that could contribute to halitosis.
- Nonoral Causes of Halitosis:Halitosis suspected or confirmed to be caused by gastrointestinal or respiratory diseases.
- Medication Use: Use of antibiotics or other medications within 1 month prior to or during the study period.
- Dental Conditions:
- Presence of dental prostheses or orthodontic appliances.
- Untreated open caries lesions or deep periodontal pockets (> 6 mm).
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- Allergies: Known allergies to any of the study interventions (e.g., chlorhexidine or coconut oil).
- Lifestyle Factors: Smoking or betel nut chewing habits.
- Inability to Comply: Inability or unwillingness to follow the study protocol or attend follow-up visits.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Faculty of Odonto-Stomatology, Hue University of Medicine and Pharmacy
Huế
About this study
Official title: The Effectiveness of Mechanical and Chemical Measures in Controlling Halitosis in the Buddhist Monastic Populations
Goal:
The goal of this clinical trial is to evaluate the effectiveness of different oral hygiene methods (tooth brushing, tongue cleaning, and mouthwash use) in managing halitosis (bad breath) in adults. The main questions it aims to answer are:
Read more
Do oral hygiene methods (tongue cleaning, chlorhexidine mouthwash, and coconut oil mouthwash) reduce the levels of volatile sulfur compounds (VSCs) in participants' breath?
Do these methods improve self-reported and clinically assessed halitosis?
Study Design:
Researchers will compare three intervention groups:
Group I: Tongue cleaning. Group II: Chlorhexidine mouthwash. Group III: Coconut oil mouthwash.
After one week, Groups II and III will add tongue cleaning, and in the third week, Groups I and III will use chlorhexidine mouthwash to ensure equitable benefits.
Participants will:
Follow their assigned oral hygiene regimen daily for 2 weeks. Receive the halitosis assessments at baseline, 1 week, and 2 weeks post-intervention, including organoleptic testing and volatile sulfur compounds level measurements using the OralChroma device.
Complete self-reported assessments of halitosis using a visual analog scale (VAS).
- Conditions
- Halitosis
- Being tested
- Mouthrinse with Coconut oil pulling, Mouthrinse with Chlorhexidine 0.12%
- Medical subject headings
- Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mouthrinse with Coconut oil pullingOther
Using mouth rinse with coconut oil for two weeks to treat halitosis
Mouthrinse with Chlorhexidine 0.12%Other
Using mouthrinse with 0.12% chlorhexidine for two weeks to treat halitosis
| Study group | Role | What they receive |
|---|---|---|
| Tongue brushing | No intervention | Not described |
| Mouthrinse with Chlorhexidine 0.12% | Active comparator | Not described Receives: Other: Mouthrinse with Chlorhexidine 0.12% |
| Mouthrinse with Coconut oil pulling | Experimental | Not described Receives: Other: Mouthrinse with Coconut oil pulling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Volatile Sulfur Compounds (VSCs) Levels
Measurement of VSC levels (hydrogen sulfide [H2S] and methyl mercaptan [CH3SH]) in participants' breath using the OralChroma device. Lower VSC levels indicate improved halitosis control.
Measured: Baseline, 1 week post-intervention, and 2 weeks post-intervention.
Improvement in Organoleptic Test (OT) Scores
Clinical assessment of halitosis severity using the Organoleptic Test, where a trained examiner scores breath odor on a scale of 0 (no odor) to 5 (extremely strong odor). A reduction in OT scores indicates improvement in halitosis.
Measured: Baseline, 1 week post-intervention, and 2 weeks post-intervention.
Improvement in Self-Reported Halitosis Severity
Participants' self-assessment of halitosis severity using a visual analog scale (VAS) ranging from 0 (no bad breath) to 100 (very severe bad breath). Lower scores indicate improved self-perceived halitosis.
Measured: Baseline, 1 week post-intervention, and 2 weeks post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start16 Mar 2024
- Primary completion30 May 2024
- Study completion30 Aug 2024
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hue University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890104
- Sponsor's protocol ID
- H2023/135
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Mechanical and Chemical Measures in Controlling Halitosis in the Buddhist Monastic Populations
- ClinicalTrials.gov ID
- NCT06890104
- Acronym / sponsor ID
- H2023/135
- Conditions
- Halitosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hue University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 16 Mar 2024 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 21 Mar 2025 (actual)
- 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.
Goal:
The goal of this clinical trial is to evaluate the effectiveness of different oral hygiene methods (tooth brushing, tongue cleaning, and mouthwash use) in managing halitosis (bad breath) in adults. The main questions it aims to answer are:
Do oral hygiene methods (tongue cleaning, chlorhexidine mouthwash, and coconut oil mouthwash) reduce the levels of volatile sulfur compounds (VSCs) in participants' breath?
Do these methods improve self-reported and clinically assessed halitosis?
Study Design:
Researchers will compare three intervention groups:
Group I: Tongue cleaning. Group II: Chlorhexidine mouthwash. Group III: Coconut oil mouthwash.
After one week, Groups II and III will add tongue cleaning, and in the third week, Groups I and III will use chlorhexidine mouthwash to ensure equitable benefits.
Participants will:
Follow their assigned oral hygiene regimen daily for 2 weeks. Receive the halitosis assessments at baseline, 1 week, and 2 weeks post-intervention, including organoleptic testing and volatile sulfur compounds level measurements using the OralChroma device.
Complete self-reported assessments of halitosis using a visual analog scale (VAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tongue brushing | No intervention | – |
| Mouthrinse with Chlorhexidine 0.12% | Active comparator | Other: Mouthrinse with Chlorhexidine 0.12% |
| Mouthrinse with Coconut oil pulling | Experimental | Other: Mouthrinse with Coconut oil pulling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: Participants must be 18 years or older.
- Diagnosis of Halitosis:
- Hydrogen sulfide (H2S) > 1.5 ng/10 ml, OR Methyl mercaptan (CH3SH) > 0.5 ng/10 ml.
- Study Population: Buddhist monks and nuns from selected temples in Hue City, Vietnam, to control for dietary and lifestyle factors.
- Willingness to Participate: Participants must provide informed consent and agree to follow the study protocol.
Key exclusion criteria (9 listed)
- Systemic Diseases: Presence of systemic conditions such as diabetes, gastrointestinal disorders, respiratory disorders, or cancer that could contribute to halitosis.
- Nonoral Causes of Halitosis:Halitosis suspected or confirmed to be caused by gastrointestinal or respiratory diseases.
- Medication Use: Use of antibiotics or other medications within 1 month prior to or during the study period.
- Dental Conditions:
- Allergies: Known allergies to any of the study interventions (e.g., chlorhexidine or coconut oil).
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 |
|---|---|---|
| Mouthrinse with Coconut oil pullingUsing mouth rinse with coconut oil for two weeks to treat halitosis | Other | Mouthrinse with Coconut oil pulling |
| Mouthrinse with Chlorhexidine 0.12%Using mouthrinse with 0.12% chlorhexidine for two weeks to treat halitosis | Other | Mouthrinse with Chlorhexidine 0.12% |
Primary outcome
Reduction in Volatile Sulfur Compounds (VSCs) Levels
Time frame: Baseline, 1 week post-intervention, and 2 weeks post-intervention.
Measurement of VSC levels (hydrogen sulfide [H2S] and methyl mercaptan [CH3SH]) in participants' breath using the OralChroma device. Lower VSC levels indicate improved halitosis control.
Improvement in Organoleptic Test (OT) Scores
Time frame: Baseline, 1 week post-intervention, and 2 weeks post-intervention.
Clinical assessment of halitosis severity using the Organoleptic Test, where a trained examiner scores breath odor on a scale of 0 (no odor) to 5 (extremely strong odor). A reduction in OT scores indicates improvement in halitosis.
Improvement in Self-Reported Halitosis Severity
Time frame: Baseline, 1 week post-intervention, and 2 weeks post-intervention.
Participants' self-assessment of halitosis severity using a visual analog scale (VAS) ranging from 0 (no bad breath) to 100 (very severe bad breath). Lower scores indicate improved self-perceived halitosis.
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 21 Mar 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mouthrinse with Coconut oil pulling and Mouthrinse with Chlorhexidine 0.12% in people with Halitosis, run by Hue University of Medicine and Pharmacy at 1 site in Vietnam.
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 7 inclusion and 9 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 21 Mar 2025. 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 Vietnam. 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.
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?
Reduction in Volatile Sulfur Compounds (VSCs) Levels (time frame: Baseline, 1 week post-intervention, and 2 weeks post-intervention.). The study lists 3 primary outcomes in all. 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 21 Mar 2025.