The effect of mouthwashes on intra-oral halitosis (bad breath)
| ISRCTN | ISRCTN18353746 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18353746 |
| Secondary identifying numbers | NL81289.018.23 |
- Submission date
- 23/08/2024
- Registration date
- 19/09/2024
- Last edited
- 18/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Mouthwashes with a combination of different agents, claiming to reduce intra-oral halitosis, are presently available on the market. There are, however, few
randomized controlled trials comparing the effectiveness of different mouthwashes on intra-oral halitosis. We aimed to evaluate the effect of three different (commercially available) oral mouthwashes and water in a single-blind four-arm randomized clinical trial on levels of hydrogen sulfide measured by gas chromatography (OralChroma).
Particularly, the mouthwash containing zinc acetate and chlorhexidine diacetate, will be compared to: a negative control (water), a positive control mouthwash containing chlorhexidine digluconate, cetylpyridinium, a mouthwash containing essential oils. Three commercially available mouthwashes are without alcohol.
Secondary objectives were:
1. To evaluate the effect of the three mouthwashes and water on methyl mercaptan levels, as measured by OralChroma, on the total oral sulfide concentration as measured with the Halimeter device and breath odor intensity with organoleptic scores.
2. To evaluate the effect of three different mouthwashes and water on tongue coating indices.
3. To evaluate the subject’s self perception of his/her own breath odor (at the baseline and end).
4. To evaluate the perception of the subject’s attitudes towards the different mouthwashes used in this study (at the end).
Study design: A three weeks, single-centre, single-blind, four-arm randomized controlled clinical trial. In total there will be four visits; screening, baseline (day 0), day 7 and day 21.
Who can participate?
Non-smoking healthy adults (age 18 years or older) with intra-oral halitosis and periodontally healthy (classified according to the Periodical Periodontal Screening (PPS) tool: PPS 1 or PPS 2 with not more than 2 sites with probing pocket depths of 5mm).
What does the study involve?
This study involves a mouthwash product containing zinc acetate and chlorhexidine diacetate without alcohol compared to a negative comparison (water). There will be a positive comparison mouthwash containing chlorhexidine digluconate, cetylpyridinium chloride and zinc lactate. Another comparison mouthwash is a commercially available mouthwash containing essential oils without alcohol. The subjects will rinse and gargle their mouth twice a day for 3 weeks according to manufacturer’s instructions.
What are the possible benefits and risks of participating?
There are no risks expected involved in participating in the study. The expectation is that the participants’ breath odor will benefit from the use of the mouthwashes. Neither immediate nor long-term physical risks are involved.
Where is the study run from?
Academic Centre for Dentistry Amsterdam (ACTA), the Netherlands.
When is the study starting and how long is it expected to run for?
May 2022 to March 2024.
Who is funding the study?
Viatris (Mylan) and Academic Centre for Dentistry Amsterdam (ACTA), the Netherlands.
Who is the main contact?
Prof. dr. M.L. Laine, m.laine@acta.nl
Contact information
Scientific
Gustav Mahlerlaan 3004
Amsterdam
1081 LA
Netherlands
 ORCID ID |
0000-0001-6052-041X |
|---|---|
| Phone | +31 (0) 20 5980876 |
| M.Laine@acta.nl |
Public
Gustav Mahlerlaan 3004
Amsterdam
1081 LA
Netherlands
| ORCID ID |
0000-0003-1269-1710 |
|---|---|
| Phone | +31 20 59 80176 |
| e.vd.sluijs@acta.nl |
Principal Investigator
Gustav Mahlerlaan 3004
Amsterdam
1081 LA
Netherlands
| ORCID ID |
0000-0001-7234-0037 |
|---|---|
| Phone | +31 20 59 80179 |
| D.Slot@acta.nl |
Study information
| Study design | Single-center single-blind four-arm randomized controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Dental clinic, University/medical school/dental school |
| Study type | Treatment, Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | The effect of different commercially available mouthwashes with active ingredients in a group of systemically and periodontally healthy subjects with intra-oral halitosis |
| Study acronym | HALI |
| Study objectives | The null hypothesis is that there is no significant difference between water and anti-halitosis mouth washes in reduction of H2S levels after 3 weeks rinsing. |
| Ethics approval(s) |
Approved 26/10/2023, METC Amsterdam UMC (Meibergdreef 9, Amsterdam, 1100DD, Netherlands; +31 (0)20 4445585; metc@amsterdamumc.nl), ref: 2023.0077 |
| Health condition(s) or problem(s) studied | Intra-oral halitosis |
| Intervention | This study involves a mouthwash product containing zinc acetate and chlorhexidine diacetate without alcohol compared to a negative comparison (water). There will be a positive comparison mouthwash containing chlorhexidine digluconate, cetylpyridinium chloride and zinc lactate. Another comparison mouthwash is a commercially available mouthwash containing essential oils without alcohol. The subjects will rinse and gargle their mouth twice a day for 3 weeks according to manufacturer’s instructions. Randomization will be based on a randomization scheme devised by www.random.org using true random numbers, which will be generated by sampling and processing a source of entropy outside the computer. The source is atmospheric noise, which is sampled and fed into a computer, avoiding any buffering mechanisms in the operating system. The primary investigator is responsible for allocation concealment. No stratification will be applied. Every participant will receive a unique trial number. A separate CRF randomization form is used to allocate Product A, B, C or D. The randomization code is kept in a sealed envelope in the Investigator Site file, which is stored in a secured area and not accessible for the examiners. Participants will be instructed not to reveal their group assignment in any way to the clinical examiner. Any intentional or unintentional breaking of blinding will be reported in source documentation and explained, irrespective of the reason for its occurrence. |
| Intervention type | Other |
| Primary outcome measure | Volatile sulphur compound hydrogen sulfide level (in ppb) assessed with the OralChroma at baseline, day 7 and 21 |
| Secondary outcome measures | Measured at baseline, day 7 and 21 unless noted otherwise: 1. Methyl mercaptan levels will be assessed by OralChroma 2. Total oral sulfide concentration will be measured with the Halimeter device and breath odor intensity with organoleptic scores 3. Winkel tongue coating index and the Gomez tongue index will be used to assess the tongue coating assessed 4. “Odostomia” questionnaire scores (subject’s perception of his/her own breath odor) will be filled out at at baseline and day 21. As well as subjects’ attitudes towards the mouthwashes used at day 21 |
| Overall study start date | 11/05/2022 |
| Completion date | 21/03/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | minimum of 13 subjects/group (N=52), maximum N=68 with 20% drop-out |
| Total final enrolment | 59 |
| Key inclusion criteria | 1. Adults ≥18 years of age 2. Classified as systemically healthy as assessed by a medical questionnaire; no systemic diseases 3. Periodontally healthy classified according to the periodical periodontal screening (pps) tool: pps 1 or pps 2 with not more than 2 sites with probing pocket depths of 5mm 4. Have a minimum of 20 natural teeth 5. Having finished the necessary dental treatment(s) 6. Willing to brush twice daily and interdental cleaning as usual 7. Willing to temporary stop cleaning the tongue and use of an oral irrigator (starts from the screening until the end of the clinical trial) 8. Willing not to use any other mouthwash than the provided mouthwash of this clinical trial (starts at least two weeks before the first visit or from screening until the end of the clinical trial) 9. Willing to temporary stop using chewing gum (starts at least two weeks before the first visit or from screening until the end of the clinical trial) 10. Willing to keep calendar on use of mouthwash 11. Willing to give their mobile phone number in order to send the participant a text message to remind them of their appointments and instructions 12. Has visit their dentist on regular basis in the past 6 months – 12 months 13. Minimal scores for intra-oral halitosis assessment at screening; 13.1. Hydrogen sulfide >112 ppb as measured by OralChroma (Erovic Ademovski et al. 2017) 13.2. Total volatile sulfur compound level >160 ppb as determined with a halimeter (Erovic Ademovski et al. 2017) and 13.3. Oral organoleptic score ≥2 (Rosenberg & Mcculloch 1992) 14. Self-reported halitosis |
| Key exclusion criteria | 1. Allergy or hypersensitive to any of the ingredients of the products; zinc acetate, chlorhexidine diacetate, cetylpyridinium chloride, essential-oils, fluoride 2. Pps 2 with > 2 sites with a probing pocket dept of 5mm 3. Pps 3 4. Open carious lesions 5. Dental students or dental care professionals 6. Self-reported pregnancy and/or lactating 7. Systemic medication related to oral dryness 8. Systemic antibiotic therapy within the preceding 3 months 9. Smoking or quitted smoking <1 year before the screening appointment 10. Extra-oral halitosis (Tangerman & Winkel 2008) 11. Night guard 12. Orthodontic brackets (retainer is allowed) 13. Removable prosthesis 14. Oral piercings |
| Date of first enrolment | 13/11/2023 |
| Date of final enrolment | 20/02/2024 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Amsterdam
1081 LA
Netherlands
Sponsor information
University/education
Gustav Mahlerlaan 15
Amsterdam
1081 LA
Netherlands
| Phone | +31 655952780 |
|---|---|
| paro@acta.nl | |
| Website | https://acta.nl |
Funders
Funder type
Industry
No information available
No information available
Results and Publications
| Intention to publish date | 15/05/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The dataset generated during and/or analysed during the current study will be available upon request from M.L. Laine (m.laine@acta.nl) for 2 years after the publication of the study. |
Editorial Notes
23/08/2024: Trial's existence confirmed by METC Amsterdam UMC.
