Efficacy of Mouthwashes in Reducing Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load in the Saliva
NCT ID: NCT04723446
Last Updated: 2023-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
54 participants
INTERVENTIONAL
2021-05-19
2021-10-25
Brief Summary
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A convenient sample of up to 40 COVID-19 positive patients diagnosed via test and/or presenting COVID-19 clinical symptoms will be identified in the inpatients and/or outpatient clinics at the Newham University Hospital and at The Royal London Hospital, Barts Health National Health Service (NHS) Trust, United Kingdom (UK).
The study will consist of one visit. Unstimulated saliva samples will be collected from all COVID-19 positive patients before and at 30 minutes, 1, 2, and 3 hours after mouth rinsing (Group 1-3 ) or no rinsing (Group 4). Viral load analysis of saliva samples in the different time-points will be then assessed by Reverse Transcription quantitative PCR (RT- qPCR).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Group 1 (test group; n= up to 10 patients) - 0.2 % Chlorhexidine digluconate
Participants will be instructed to rinse their mouth with 10 ml of Corsodyl® Alcohol free mouthwash for 1 minute.
Corsodyl® Alcohol free -0.2 % Chlorhexidine digluconate
Corsodyl® Alcohol-free is a clear to slightly opalescent oromucosal solution with an odour of peppermint that contains 0.2% w/v chlorhexidine digluconate which is an antimicrobial preparation for external use. It is effective against a wide range of Gram negative and Gram positive vegetative bacteria, yeasts, dermatophyte fungi and lipophilic viruses. It is active against a wide range of important oral pathogens and is therefore effective in the treatment of many common oral conditions.
Group 2 (test group; n= up to 10 patients) - 1.5% Hydrogen peroxide
Participants will be instructed to rinse their mouth with 10 ml of Colgate® Peroxyl mouthwash for 1 minute.
Colgate Peroxyl® -1.5% Hydrogen peroxide
Peroxyl mouthwash is a clear aqua-blue liquid oromucosal solution which 100ml of solution contains 1.5g of Hydrogen peroxide (as 30% Hydrogen Peroxide solution). It is an oral antiseptic cleanser for external use. The principal action is brought about by contact of hydrogen peroxide with peroxidases and catalases present in tissues and saliva, which causes the rapid release of oxygen. This provides mechanical cleansing which flushes out mouth debris and helps in the treatment of oral irritations. This mouthwash is used as a cleanser in the symptomatic relief of minor mouth and gum irritations.
Group 3 (test group; n= up to 10 patients) - Cetylpyridinium chloride
Participants will be instructed to rinse their mouth with 10 ml of Oral-B® Gum \& Enamel Care mouthwashes for 1 minute.
Oral-B® Gum & Enamel Care -Cetylpyridinium chloride
The Oral-B® Gum \& Enamel Care mouthwash is an oromucosal solution containing Cetylpyridinium chloride (CPC) and used as an adjunct to oral hygiene.
Group 4 (control group; n= up to 10 patients) - No rinsing
Patients will be instructed to not rinse their mouth with any solution, not even water.
No rinsing
No rinsing
Interventions
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Corsodyl® Alcohol free -0.2 % Chlorhexidine digluconate
Corsodyl® Alcohol-free is a clear to slightly opalescent oromucosal solution with an odour of peppermint that contains 0.2% w/v chlorhexidine digluconate which is an antimicrobial preparation for external use. It is effective against a wide range of Gram negative and Gram positive vegetative bacteria, yeasts, dermatophyte fungi and lipophilic viruses. It is active against a wide range of important oral pathogens and is therefore effective in the treatment of many common oral conditions.
Colgate Peroxyl® -1.5% Hydrogen peroxide
Peroxyl mouthwash is a clear aqua-blue liquid oromucosal solution which 100ml of solution contains 1.5g of Hydrogen peroxide (as 30% Hydrogen Peroxide solution). It is an oral antiseptic cleanser for external use. The principal action is brought about by contact of hydrogen peroxide with peroxidases and catalases present in tissues and saliva, which causes the rapid release of oxygen. This provides mechanical cleansing which flushes out mouth debris and helps in the treatment of oral irritations. This mouthwash is used as a cleanser in the symptomatic relief of minor mouth and gum irritations.
Oral-B® Gum & Enamel Care -Cetylpyridinium chloride
The Oral-B® Gum \& Enamel Care mouthwash is an oromucosal solution containing Cetylpyridinium chloride (CPC) and used as an adjunct to oral hygiene.
No rinsing
No rinsing
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Males and females, ≥ 18 years old.
* COVID-19 positive patients confirmed via any diagnostic test and/or presented with COVID-19 clinical symptoms at point of consent.
Exclusion Criteria
* Known pre-existing chronic mucosal lesions e.g. lichen planus or other oropharyngeal lesions, reported by patient or recorded in the existing patient' medical notes;
* Patients currently intubated or not capable of mouth rinse or spit;
* History of head and neck radiotherapy or chemotherapy;
* Self-reported xerostomia;
* Known allergy or hypersensitivity to chlorhexidine digluconate or one of the mouthwashes constituents;
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial;
* Inability to comply with study protocol.
18 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Queen Mary University of London
OTHER
Responsible Party
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Principal Investigators
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Prof Nikos Donos, PhD
Role: PRINCIPAL_INVESTIGATOR
Queen Mary University London
Locations
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Newham Hospital
London, , United Kingdom
Royal London Hospital
London, , United Kingdom
Countries
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References
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Related Links
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Efficacy of three antimicrobial mouthwashes in reducing SARS-CoV-2 viral load in the saliva of hospitalized patients: a randomized controlled pilot study
Other Identifiers
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TBC
Identifier Type: -
Identifier Source: org_study_id
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