Assessment of oral malodour and tonsil bacteria after gargling of throat with an antiseptic
| ISRCTN | ISRCTN67671859 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67671859 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/08/2015
- Registration date
- 19/08/2015
- Last edited
- 19/08/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
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
Contact information
Public
2-11 Suemori-Dori Chikusa-Ku
Nagoya
464-8651
Japan
| Phone | +81 52 759 2150 |
|---|---|
| fukuda-m@dpc.agu.ac.jp |
Scientific
Department of Periodontology
School of Dentistry
Aichi Gakuin University
Nagoya
470-0195
Japan
 ORCID ID |
0000-0001-9742-5184 |
|---|
Study information
| Study design | Single-centre randomised controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Treatment |
| Scientific title | Assessment of oral malodour and tonsillar microbiota after gargling in orophrynx with benzethonium chloride |
| 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(s) | The Ethics Committee of Aichi Gakuin University, 23/07/2010, ref: 227; and 14/03/2014, ref: 371. |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | Benzethonium chloride |
| Primary outcome measure | 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 study start date | 24/07/2010 |
| Overall study end date | 31/03/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 150 |
| 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 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
Study participating centre
2-11 Suemori-Dori Chikusa-Ku
Nagoya
464-8651
Japan
Sponsor information
University/education
2-11 Suemori-Dori Chikusa-Ku
Nagoya
464-8651
Japan
| Phone | +81 52 759 2150 |
|---|---|
| fukuda-m@dpc.agu.ac.jp | |
"ROR" |
https://ror.org/01rwx7470 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/03/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| 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. |
| IPD sharing plan |
