Effects of Mechanical, Chemical, and Combination Methods on Halitosis

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:

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 Overview

• Status: Completed
• Conditions: Halitosis
• Intervention / Treatment: Other: Mouthrinse with Chlorhexidine 0.12%; Other: Mouthrinse with Coconut oil pulling

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Tongue brushing
Active Comparator: Mouthrinse with Chlorhexidine 0.12%	Other: Mouthrinse with Chlorhexidine 0.12%; Using mouthrinse with 0.12% chlorhexidine for two weeks to treat halitosis
Experimental: Mouthrinse with Coconut oil pulling	Other: Mouthrinse with Coconut oil pulling; Using mouth rinse with coconut oil for two weeks to treat halitosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline, 1 week post-intervention, and 2 weeks post-intervention.

Collaborators and Investigators

• Sponsor: Hue University of Medicine and Pharmacy

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2024
• Primary Completion (Actual): May 30, 2024
• Study Completion (Actual): August 30, 2024

Study Registration Dates

• First Submitted: March 17, 2025
• First Submitted That Met QC Criteria: March 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Halitosis; Anti-Infective Agents; Anti-Infective Agents, Local; Disinfectants; Chlorhexidine
• Other Study ID Numbers: H2023/135

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No