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Effects of Mechanical, Chemical, and Combination Methods on Halitosis

H

Hue University of Medicine and Pharmacy

Status

Completed

Conditions

Halitosis

Treatments

Other: Mouthrinse with Chlorhexidine 0.12%
Other: Mouthrinse with Coconut oil pulling

Study type

Interventional

Funder types

Other

Identifiers

NCT06890104
H2023/135

Details and patient eligibility

About

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).

Enrollment

42 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

42 participants in 3 patient groups

Tongue brushing
No Intervention group
Mouthrinse with Chlorhexidine 0.12%
Active Comparator group
Treatment:
Other: Mouthrinse with Chlorhexidine 0.12%
Mouthrinse with Coconut oil pulling
Experimental group
Treatment:
Other: Mouthrinse with Coconut oil pulling

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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