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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

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

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03

Who can participate

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

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 informed consent 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.
04

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

05

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.

06

Study locations

1 site
  • Faculty of Odonto-Stomatology, Hue University of Medicine and Pharmacy
    Hue, Vietnam
07

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 ↗

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