Clinical trial NCT06890104: Effects of Mechanical, Chemical, and Combination Methods on Halitosis
Official title: The Effectiveness of Mechanical and Chemical Measures in Controlling Halitosis in the Buddhist Monastic Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Halitosis
Lead sponsor: Hue University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Reduction in Volatile Sulfur Compounds (VSCs) Levels
timeFrame: Baseline, 1 week post-intervention, and 2 weeks post-intervention.
measure: Improvement in Organoleptic Test (OT) Scores
timeFrame: Baseline, 1 week post-intervention, and 2 weeks post-intervention.
measure: Improvement in Self-Reported Halitosis Severity
timeFrame: Baseline, 1 week post-intervention, and 2 weeks post-intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Hue
country: Vietnam
facility: Faculty of Odonto-Stomatology, Hue University of Medicine and Pharmacy
Study officials:
References: