Assessing the effectiveness of mouthwashes against SARS-CoV-2 before dental procedures
| ISRCTN | ISRCTN16269648 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16269648 |
| IRAS number | 300106 |
| Secondary identifying numbers | IRAS 300106, CPMS 49628 |
- Submission date
- 23/06/2021
- Registration date
- 24/06/2021
- Last edited
- 18/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. Dentistry is currently severely limited during the COVID-19 pandemic. Aerosol-generating dental procedures may spread the virus from asymptomatic COVID-positive patients. The COVID virus has been already shown to be present in saliva in significant quantities. Dental staff are currently protected through the use of appropriate Personal Protective Equipment (PPE), but there are concerns about the safety of the next patient to enter the surgery, as there could theoretically be viable virus circulating in the air from the previous patient's procedure. As a result of this, patients are having difficulty or may be reluctant to access dental appointments and care, leading to a backlog of cases, the potential for oral health in the UK to suffer and many dental practices to become financially unviable or the cost of treatment to increase. This study hopes to address the problem by testing whether the SARS-Cov-2 virus can be made inactive before dental procedures.
A number of dentists have already suggested the idea of using mouthwashes to inactivate the virus, not only for dental procedures, but as part of a broader measure to help control the spread of the pandemic in the population. Pre-procedural mouthwashes have been in common use in dentistry for many years and have proven to reduce bacteria in aerosols although not viruses. An investigation has identified four commercially available mouthwashes in the laboratory setting. This study aims to develop this theory further by asking COVID-positive patients to provide saliva samples at timed intervals to test the effectiveness of various mouthwashes against the SARS-Cov-2 virus, and also the length of time they are effective for. It is important to know if the virus is still infective rather than just knowing its presence, so live culture of samples is necessary. It is not currently known how much virus is required to infect an individual.
Who can participate?
People over the age of 16 years who have had a positive COVID-19 test within the last 72 hours with mild to moderate symptoms of COVID-19
What does the study involve?
The study involves participants providing saliva samples before and after using a mouthwash (Orawise+, Listerine Total Care, Listerine Cool Mint) or a control solution (bottled water). Samples will be taken pre mouthwash, then at 1, 10, 30 and 60 minutes after using a mouthwash.
What are the possible benefits and risks of participating?
There will be no benefit to the participant but the findings may benefit other patients in the future and help provide us with a better understanding of the SARS-Cov-2 virus.
Where is the study run from?
York Hospital (UK)
When is the study starting and how long is it expected to run for?
July 2020 to June 2022
Who is funding the study?
Johnson & Johnson (USA)
Who is the main contact?
Mia Porteous
mia.porteous@york.nhs.uk
Mouthwash@york.nhs.uk
Contact information
Public
York & Scarborough Teaching Hospitals NHS Foundation Trust
York Hospital
Wigginton Road
York
YO31 8HE
United Kingdom
| Phone | +44 (0)1904 725129 |
|---|---|
| mia.porteous@york.nhs.uk |
Scientific
York & Scarborough Teaching Hospitals NHS Foundation Trust
York Hospital
Wigginton Road
York
YO31 8HE
United Kingdom
| Phone | +44 (0)1904 725129 |
|---|---|
| David.Seymour@york.nhs.uk |
Study information
| Study design | Single-centre interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Investigating the effectiveness of oral antiseptic rinses on SARS-CoV-2 in-vivo - a randomised controlled trial |
| Study objectives | To test methods of mitigating the risk of SARS-CoV-2 in the dental setting by rendering it non-infective prior to procedures. The methods for investigation will be the use of a pre-procedural mouthwash. |
| Ethics approval(s) | Approved 14/06/2021, North of Scotland Research Ethics Committee (Summerfield House, 2 Eday Road, Aberdeen, AB15 6RE, UK; +44 (0)1224 558458; gram.nosres@nhs.scot), REC ref: 21/NS/0073 |
| Health condition(s) or problem(s) studied | COVID-19 (SARS-CoV-2 infection) |
| Intervention | Participants with a positive COVID test within the last 72 hours will be randomised to four types of mouthwash by a random number generator. The mouthwashes to be tested are as follows: 1. Orawise+ (hypochlorous acid) 2. Listerine Total Care (eucalyptol, thymol, menthol, sodium fluoride, zinc chloride) 3. Listerine Cool Mint (alcohol, eucalyptol, thymol, menthol) 4. Control group (bottled water) Participants will be randomised to a mouthwash or the control group. Saliva samples will be collected prior to mouth washing (baseline), then at 1, 10, 30 and 60 minutes after mouth washing. These saliva samples will then be frozen and cultured for viable virus with Public Health England. |
| Intervention type | Other |
| Primary outcome measure | Levels of SARS-CoV-2 in saliva samples measured quantitatively by determining the 50% tissue culture infectious dose (TCID50) and the infectious virus titre in TCID50/ml, at baseline (pre-mouth washing) and 1, 10, 30 and 60 minutes after mouth washing |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/07/2020 |
| Completion date | 16/06/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 92 |
| Total final enrolment | 92 |
| Key inclusion criteria | 1. Participants aged over 16 years with a positive COVID-19 swab test in the last 72 hours 2. Participants will only be recruited if they are well enough, i.e. only showing mild to moderate symptoms/signs of COVID-19 infection |
| Key exclusion criteria | 1. Refusal of consent 2. Participants known to be pregnant 3. Participants who have allergies to any of the mouthwashes used in the trial |
| Date of first enrolment | 28/06/2021 |
| Date of final enrolment | 16/06/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
York
YO31 8HE
United Kingdom
Sponsor information
Hospital/treatment centre
Wigginton Road
York
YO31 8HE
England
United Kingdom
| Phone | +44 (0)1904 725123 |
|---|---|
| mouthwash@york.nhs.uk | |
| Website | https://www.yorkhospitals.nhs.uk |
"ROR" |
https://ror.org/027e4g787 |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Johnson & Johnson, johnson & Johnson Services, Inc., Johnson&Johnson, 强生公司, Johnson & Johnson Private Limited, ジョンソン・エンド・ジョンソント, J&J, JNJ
- Location
- United States of America
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. The statistical analysis plan can be made available by contacting the main study contact should this be required. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version V9.0 | 14/06/2021 | 24/06/2021 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Preprint results | 13/10/2023 | 18/12/2023 | No | No |
Additional files
- ISRCTN16269648_PROTOCOL_V9.0_14Jun21.docx
- Uploaded 24/06/2021
Editorial Notes
18/12/2023: Publication reference added.
08/06/2023: The intention to publish date was changed from 28/06/2023 to 31/12/2023.
22/06/2022: The following changes have been made:
1. The overall trial end date has been changed from 28/06/2022 to 16/06/2022.
2. The recruitment end date has been changed from 28/06/2022 to 16/06/2022.
3. Added total final enrollment.
24/06/2021: Trial's existence confirmed by North of Scotland Research Ethics Committee. Uploaded protocol Version 9.0, 14 June 2021 (not peer-reviewed).
