ClinicalTrials.gg
CompletedNCT06890104Updated Mar 21, 2025

Effects of Mechanical, Chemical, and Combination Methods on Halitosis

An interventional study of Mouthrinse with Coconut oil pulling and Mouthrinse with Chlorhexidine 0.12% in Halitosis, sponsored by Hue University of Medicine and Pharmacy. Completed at 1 site in Vietnam. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-21.

Sponsored by Hue University of Medicine and Pharmacy · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Mar 2024, registered Mar 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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).

02

Conditions studied

  • Halitosis

Browse trials for

03

In context

Halitosis

93 studies on the registry are indexed under Halitosis; 17 are open to participants now.

This study's enrollment of 42 is close to the median of 45 across 79 interventional studies indexed under Halitosis.

Browse Halitosis studies →

Lead sponsor

Hue University of Medicine and Pharmacy is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 and agree to follow the study protocol.

Exclusion criteria

Exclusion Criteria:

  • 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).
  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
42 participants (actual)

Study arms

  • No intervention
    Tongue brushing
  • Active comparator
    Mouthrinse with Chlorhexidine 0.12%

    Other: Mouthrinse with Chlorhexidine 0.12%

  • Experimental
    Mouthrinse with Coconut oil pulling

    Other: Mouthrinse with Coconut oil pulling

Interventions

  • OtherMouthrinse with Coconut oil pulling

    Using mouth rinse with coconut oil for two weeks to treat halitosis

  • OtherMouthrinse with Chlorhexidine 0.12%

    Using mouthrinse with 0.12% chlorhexidine for two weeks to treat halitosis

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 1 week post-intervention, and 2 weeks post-intervention.

  2. 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.

    Time frame: Baseline, 1 week post-intervention, and 2 weeks post-intervention.

  3. 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.

    Time frame: Baseline, 1 week post-intervention, and 2 weeks post-intervention.

07

Study locations

1 site
  • Faculty of Odonto-Stomatology, Hue University of Medicine and Pharmacy
    Hue, Vietnam
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2024 to primary completion in May 2024, 2 months.

Of 35 non-industry interventional studies with no phase under Halitosis, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 18. This study's 2 months is below that.

Counting every sponsor, half of 43 studies reached it within 10 months; a quarter within 3 and three quarters within 18.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 17, 2025
First posted
Mar 21, 2025
StartActual
Mar 16, 2024
Primary completionActual
May 30, 2024
CompletionActual
Aug 30, 2024
Last update
Mar 21, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06890104
Lead sponsor
Hue University of Medicine and Pharmacy
Responsible party
Sponsor
First posted
Mar 21, 2025
Start date
Mar 16, 2024
Primary completion
May 30, 2024
Completion
Aug 30, 2024
Last update
Mar 21, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion