Investigating the effectiveness of commercially available mouthwash on SARS-CoV-2 in vivo using viable virus titre as the primary outcome. A randomised controlled trial
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This multi-arm, parallel group, single-blinded randomised controlled trial aimed to assess three commercially available mouthwashes effectiveness against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This manuscript has been written in accordance with the CONSORT statement.
Methods. Eligible participants were SARS-CoV-2 positive with a positive test in the last 72 h. All participants had mild to moderate symptoms and could provide five saliva samples over a 60 min period. Participants delivered a baseline saliva sample and then used a mouthwash as per manufacturer’s instructions. They provided further saliva samples at minute 1, 10, 30 and 60. Participants were randomised to one of four groups; OraWize+, Total Care Listerine, Cool Mint Listerine and water (control). The lab-based research team were blind to the intervention. The research question was: can SARS-CoV-2 be rendered inactive in saliva by using a mouthwash and how long does this effect last? The primary outcome was the amount of viable infectious SARS-CoV-2 virus in the sample, compared to the baseline sample. The secondary outcome measure was the amount of genetic material from the SARS-CoV-2 virus in the sample, measured via PCR testing.
Results. In total 100 participants were recruited (25 per group). Eight participants did not receive the allocated intervention and did not have saliva samples collected. There were no adverse events. In total 42 of the 92 participants had viable virus which could be cultured at baseline. Statistical analysis of the primary outcome was not advised due to the reduced level of viable virus at baseline and the positive skewness present in the distribution of log10(titre) data. Observational data of the primary outcome measure is presented.
Analysis of the secondary outcome PCR measure showed that there was strong evidence for a decrease in SARS-CoV-2 RNA levels compared to water for all mouthwashes after 1 min, OraWize+ −0.49 (−0.92, –0.05), p -value 0.029, Cool Mint Listerine −0.81 (−1.25, –0.38), p -value<0.001, Total Care Listerine −1.05 (−1.48, –0.62), p -value<0.001. For the remaining timepoints there was generally no evidence of virus level reduction compared to water although there is weak evidence for a decrease at ten minutes using Total Care Listerine −0.44 (−0.88, 0.01), p -value 0.053.
Conclusion. The three mouthwashes included in this trial observationally demonstrated a reduction in virus titre level 1 min after use, with virus levels normalising up to 60 min compared to the control. Although an interesting observation, this result could not be statistically analysed. Using the secondary outcome PCR measure all three included mouthwashes reduced virus levels compared to water at 1 min and these results were statistically significant. Clinically this result does not support the use of the included mouthwashes to reduce SARS-CoV-2 levels in saliva.
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This is a study that would be of interest to the field and community.
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This is a study that would be of interest to the field and community.
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Comments to Author
Dear authors, This study untitled "Investigating the effectiveness of commercially available mouthwash on SARS-CoV-2 in-vivo using viable virus titre as the primary outcome. A randomised controlled trial" compared 4 mouthwash on SARS-CoV2. The primary outcome was the amount of viable infectious SARS-CoV-2 virus in the sample, compared to the baseline sample. The secondary outcome measure was the amount of genetic material from the SARS-CoV-2 virus in the sample, measured via PCR testing. Introduction 1. Ref 3 and 4. You should add more recent references such as DOI10.3390/v13050895, DOI10.3389/fmicb.2021.786042… 2. The introduction should be revised and cite articles than analyzed the effect of mouthwash on SARS-CoV-2 contained in the saliva (doi: 10.1016/j.jdsr.2023.09.003, …
Comments to Author
Dear authors, This study untitled "Investigating the effectiveness of commercially available mouthwash on SARS-CoV-2 in-vivo using viable virus titre as the primary outcome. A randomised controlled trial" compared 4 mouthwash on SARS-CoV2. The primary outcome was the amount of viable infectious SARS-CoV-2 virus in the sample, compared to the baseline sample. The secondary outcome measure was the amount of genetic material from the SARS-CoV-2 virus in the sample, measured via PCR testing. Introduction 1. Ref 3 and 4. You should add more recent references such as DOI10.3390/v13050895, DOI10.3389/fmicb.2021.786042… 2. The introduction should be revised and cite articles than analyzed the effect of mouthwash on SARS-CoV-2 contained in the saliva (doi: 10.1016/j.jdsr.2023.09.003, DOI10.1016/j.cmi.2021.05.028, doi: 10.1016/j.jhin.2023.06.022…) 3. There is always several studies analyzing the effect of mouthwash on SARS-CoV-2in the saliva. Could you precise the originality of your study? Material and methods 1. L156 "Further 5ml saliva samples were then provided" Please describe the process to collect the saliva 2. Could you precise the date of initiation and end of the study? 3. L141-144 Are you sure that no data was available when you did your study? As the study is old (28th June 2021 to 16th June 2022) then why did not have published the results before? 4. Present the composition of mouthwashes Discussion 1. It will be interesting to understand which active compound of each mouthwash tested could be act against SARS-CoV-2. 2. The discussion lack of comparison with studies analyzing the effect of mouthwashes on SARS-CoV-2.
Please rate the manuscript for methodological rigour
Good
Please rate the quality of the presentation and structure of the manuscript
Satisfactory
To what extent are the conclusions supported by the data?
Partially support
Do you have any concerns of possible image manipulation, plagiarism or any other unethical practices?
No
Is there a potential financial or other conflict of interest between yourself and the author(s)?
No
If this manuscript involves human and/or animal work, have the subjects been treated in an ethical manner and the authors complied with the appropriate guidelines?
Yes
-
Comments to Author
This is an important paper. Thank you very much. There is a lot of discussion about the use of mouth washes for SARS-COV-2 treatment and data from e.g. suspension tests supporting their activity. At least the tested mouth washes seems to not have any significant clinical effect. I like to see the paper published after minor changes: - Please add the "active principle" in the material section. What are the expected antiviral ingredients of the used preparations? - Please add an explanation in the discussion why you could not statistically analyse the primary outcome. I think this is an (acceptable) limitation. - You did not mention some of the papers showing SARS-COV-2 activities e.g. o https://pubmed.ncbi.nlm.nih.gov/34752803/ o https://pubmed.ncbi.nlm.nih.gov/34752803/ o …
Comments to Author
This is an important paper. Thank you very much. There is a lot of discussion about the use of mouth washes for SARS-COV-2 treatment and data from e.g. suspension tests supporting their activity. At least the tested mouth washes seems to not have any significant clinical effect. I like to see the paper published after minor changes: - Please add the "active principle" in the material section. What are the expected antiviral ingredients of the used preparations? - Please add an explanation in the discussion why you could not statistically analyse the primary outcome. I think this is an (acceptable) limitation. - You did not mention some of the papers showing SARS-COV-2 activities e.g. o https://pubmed.ncbi.nlm.nih.gov/34752803/ o https://pubmed.ncbi.nlm.nih.gov/34752803/ o https://pubmed.ncbi.nlm.nih.gov/32726430/ - Those studies show other potential candidates that seems to have an effect e.g. povidone-iodine. Please elaborate that in the discussion. Even though the included products did not show a substantial effect, the general principle may be helpful for infection prevention with other products. Apart from this minor points the study is presented clear and straight forward. Great.
Please rate the manuscript for methodological rigour
Very good
Please rate the quality of the presentation and structure of the manuscript
Very good
To what extent are the conclusions supported by the data?
Strongly support
Do you have any concerns of possible image manipulation, plagiarism or any other unethical practices?
No
Is there a potential financial or other conflict of interest between yourself and the author(s)?
No
If this manuscript involves human and/or animal work, have the subjects been treated in an ethical manner and the authors complied with the appropriate guidelines?
Yes
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