Effects of Mechanical, Chemical, and Combination Methods on Halitosis

NCT ID: NCT06890104

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-16
• Study Completion Date: 2024-08-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Tongue brushing

Group Type: NO_INTERVENTION

No interventions assigned to this group

Mouthrinse with Chlorhexidine 0.12%

Group Type: ACTIVE_COMPARATOR

Mouthrinse with Chlorhexidine 0.12%

Intervention Type: OTHER

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

Mouthrinse with Coconut oil pulling

Group Type: EXPERIMENTAL

Mouthrinse with Coconut oil pulling

Intervention Type: OTHER

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

Interventions

Mouthrinse with Coconut oil pulling

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

Intervention Type: OTHER

Mouthrinse with Chlorhexidine 0.12%

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hue University of Medicine and Pharmacy

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Huế, , Vietnam

Countries

Vietnam

Other Identifiers

H2023/135

Identifier Type: -

Identifier Source: org_study_id