Condition category
Ear, Nose and Throat
Date applied
12/08/2015
Date assigned
19/08/2015
Last edited
19/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Other than the mouth, the ear, nose and throat (ENT) region is one of the areas most affected by bad breath, also known as halitosis or oral malodour. It is thought that one of the main causes of bad breath is an infection in the tonsils on either side of the back of the throat. However, the link between healthy tonsils to halitosis is not well studied. It is thought that the bacteria which are always present on the tonsils, even if there is no infection, produce volatile sulphur compounds (VSCs), which lead to bad breath. The aim of this study is to find out whether people with healthy tonsils can still suffer from halitosis, and if gargling with an antibacterial mouthwash can make a difference.

Who can participate?
Patients who think they have bad breath, and who have not been on antibiotics or seen an ENT doctor for sinus or tonsil problems within the past 3 months.

What does the study involve?
Participants are randomly divided into three groups. The first group gargles a benzethonium chloride mouthwash four times a day for nine days. The section group gargles an inactive (placebo) mouthwash containing sterile distilled water containing the same artificial colorants as in the active mouthwash four times a day for nine days. The third group are instructed not to gargle anything for the nine days of the study. Before the study begins and after it is finished, the levels of the VSC’s in the mouth are measured. Patients are also asked how strong they think their bad breath is. During the nine days of the study, all participants have their teeth professionally cleaned by a dentist every three days.

What are the possible benefits and risks of participating?
Possible benefits for participants include possible improvement in bad breath. Risks associated with participation include allergy for antiseptic and spending time to visit hospital for PMTC.

Where is the study run from?
Division of Periodontal Health Promotion, Aichi Gakuin University Dental Hospital (Japan)

When is the study starting and how long is it expected to run for?
July 2010 to March 2016

Who is funding the study?
The Ministry of Education, Culture, Sports, Science and Technology (Japan)

Who is the main contact?
Dr Mitsuo Fukuda
Fukuda-m@dpc.agu.ac.jp

Trial website

Contact information

Type

Public

Primary contact

Prof Mitsuo Fukuda

ORCID ID

Contact details

2-11 Suemori-Dori Chikusa-Ku
Nagoya
464-8651
Japan
+81 52 759 2150
fukuda-m@dpc.agu.ac.jp

Type

Scientific

Additional contact

Prof Jun-ichiro Hayashi

ORCID ID

http://orcid.org/0000-0001-9742-5184

Contact details

Department of Periodontology
School of Dentistry
Aichi Gakuin University
Nagoya
470-0195
Japan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Assessment of oral malodour and tonsillar microbiota after gargling in orophrynx with benzethonium chloride

Acronym

Study hypothesis

1. The microbiota of healthy tonsil is one of the source of halitosis.
2. Management of the microbiota by gargling with antiseptics reduces halitosis.

Ethics approval

The Ethics Committee of Aichi Gakuin University, 23/07/2010, ref: 227; and 14/03/2014, ref: 371.

Study design

Single-centre randomised controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

Condition

Halitosis without periodontitis and otolaryngological disease.

Intervention

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.

Intervention type

Drug

Phase

Drug names

Benzethonium chloride

Primary outcome measures

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 measures

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.

Overall trial start date

24/07/2010

Overall trial end date

31/03/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

150

Participant 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

Recruitment start date

01/08/2010

Recruitment end date

31/12/2015

Locations

Countries of recruitment

Japan

Trial participating centre

Aichi Gakuin University Dental Hospital
Division of Periodontal Health Promotion 2-11 Suemori-Dori Chikusa-Ku
Nagoya
464-8651
Japan

Sponsor information

Organisation

Aichi Gakuin University

Sponsor details

2-11 Suemori-Dori Chikusa-Ku
Nagoya
464-8651
Japan
+81 52 759 2150
fukuda-m@dpc.agu.ac.jp

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

A pilot data is planned to publish in an international journal of dental field. Further plans to be confirmed at a later date.

Intention to publish date

31/03/2016

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes