Effects of Mechanical, Chemical, and Combination Methods on Halitosis

NCT06890104 | Completed

• 1 other identifier: H2023/135
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Halitosis

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (3)

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

Interventions

Mouthrinse with Coconut oil pulling OTHER

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

Mouthrinse with Coconut oil pulling

Mouthrinse with Chlorhexidine 0.12% OTHER

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

Mouthrinse with Chlorhexidine 0.12%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hue University of Medicine and Pharmacy: lead

Study Sites (1)

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

Huế, Vietnam

Location

MeSH Terms

Conditions

Halitosis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 21, 2025
• Study Start: March 16, 2024
• Primary Completion: May 30, 2024
• Study Completion: August 30, 2024
• Last Updated: March 21, 2025

Record last verified: 2025-03

Locations

VN (1)