Assessment of oral malodour and tonsil bacteria after gargling of throat with an antiseptic

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN67671859
• Date of registration: 19/08/2015
• Prospective Registration: No
• Primary sponsor: Aichi Gakuin University
• Public title: Assessment of oral malodour and tonsil bacteria after gargling of throat with an antiseptic
• Scientific title: Assessment of oral malodour and tonsillar microbiota after gargling in orophrynx with benzethonium chloride
• Date of first enrolment: 01/08/2010
• Target sample size: 150
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN67671859
• Study type: Interventional
• Study design: Single-centre randomised controlled trial. (Treatment)

Countries of recruitment

Japan

Contacts

• Name: Mitsuo Fukuda

• Name: Jun-ichiro Hayashi

Key inclusion & exclusion criteria

Inclusion criteria: 1. To have visited the Aichi Gakuin University Dental Hospital and claiming oral malodour
2. No history of antibiotic use within the past 3 months
3. No history of otolaryngology consultation due to sinusitis, tonsillitis and tonsilloliths within the past 3 months
Exclusion criteria: 1) Otolaryngological disease at baseline
2) Periodontitis
3) To have used a gargle on the day of screening
4) A negative result for an organoleptic assessment (score 0)
5) Less than 26 ppb CH3SH in mouth air
6) Score of more than 30% on the Plaque Control Record

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Halitosis without periodontitis and otolaryngological disease.
Ear, Nose and Throat
Halitosis

Intervention(s)

Participants are randomly allocated into three groups:
1. Test Group: Instructed to gargle with mouthwash containing 0.004% benzethonium chloride and artificial colorants (tartrazine and Brilliant Blue FCF) for 1 minute, four times per day for 9 days.
2. Placebo Group: Instructed to gargle with the placebo mouthwash (sterile distilled water containing the artificial colorants) for 1 minute, four times per day for 9 days.
3. Control Group: Instructed not to gargle during test period.
During the 9-day test period, all of the participants underwent professional mechanical tooth cleaning (PMTC) every 3 days. The volatile sulfur compounds (VSCs) concentration in mouth air, organoleptic score and profile of tonsillar microbiota of halitosis patient were assessed before and after gargling with benzethonium chloride.

Primary Outcome(s)

Comparing the concentrations of VSC's (H2S, CH3SH, and CH3SCH3) in mouth air, measured using OralChroma, and organoleptic score, determined using the Rosenberg’s scale. Outcomes are measured at baseline and after 9 days.

Secondary Outcome(s)

Outcomes are measured at baseline and after 9 days:
1. Concentrations of VSCs are measured using OralChroma.
2. Organoleptic assessment is judged on a 0–5 scale (Rosenberg’s scale).
3. Tongue coating score is recorded with Kojima’s scale.
4. Bacterial profiles are assessed by T-RFLP analysis.

Secondary ID(s)

N/A

Source(s) of Monetary Support

The Ministry of Education, Culture, Sports, Science and Technology (JAPAN)