Covid19NCT04719208
[COVID-19] Reduction of Sars-CoV-2 Oral Viral Load With Prophylactic Mouth Rinse
A study testing Water (E) Mouth rinse with the solution provided, Chlorhexidine gluconate (A) Mouth rinse with the solution provided and Hydrogen peroxide (B) Mouth rinse with the solution provided in people with Covid19, run by Augusta University at 2 sites in United States.
Trial summary
The purpose of this study is to test the effectiveness of prophylactic mouth rinses in reducing the amount of viruses, specifically SARS-CoV-2 in the oral cavity. This research will guide dental and medical providers on best practices to be performed prior to dental and medical procedures involving the oral cavity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Water (E) Mouth rinse with the solution provided, Chlorhexidine gluconate (A) Mouth rinse with the solution provided and Hydrogen peroxide (B) Mouth rinse with the solution provided
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Oct 2020to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject of both sexes, aged 18 years or older
- Patients who are confirmed positive for COVID-19.
- Patients currently hospitalized at Augusta University Medical Center.
- Subject voluntarily signing the informed consent document.
Who cannot join
- Age younger than 18 years old.
- Patients that are tested negative for COVID-19
- Patient who are intubated or too sick to give consent for the study.
- Not able to speak in English or illiterate or lacking the decision-making capacity to consent for study.
- Known allergy to Listerine, Betadine or Chlorhexidine gluconate
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Augusta University
Augusta, Georgia, 30901
Augusta University-Dental College of Georgia
Augusta, Georgia, 30912
About this study
Official title: Reduction of Sars-CoV-2 Oral Viral Load With Prophylactic Mouth Rinse
The purpose of this study is to test the effectiveness of prophylactic mouth rinses in reducing the amount of viruses, specifically SARS-CoV-2 in the oral cavity. This research will guide dental and medical providers on best practices to be performed prior to dental and medical procedures involving the oral cavity.
Read the detailed description
In response to SARS-CoV-2 the dental and greater healthcare communities have devised ways to combat the spread of the virus. Many dentists and physicians have advocated the use of prophylactic oral rinses for reduction of COVID-19 viral load in all patients prior to treatment in the oral pharyngeal cavity, but the effectiveness of these measures has not been validated with empirical evidence. The investigators will test COVID-19 positive hospital inpatients before and after the use of different combinations of oral rinses to provide guidance on best measures for dental or medical treatment. This research is imperative and essential as prophylactic rinses are already being used at AU and globally, without data to support their effectiveness specifically in COVID-19 positive patients.
Oral rinses have been used as an industry standard in dentistry for decades to reduce oral levels of pathogens including bacteria and viruses. According to the American Academy of Dentistry mouth rinses can be broken down into two categories, cosmetic and therapeutic. Those categorized as therapeutic include chlorhexidine, essential oils, fluoride, and hydrogen peroxide. These rinses are routinely used in both dental practices as well as in the OR setting prior to any invasive procedure involving treatment of the oral cavity. However, these mouth rinses, are typically utilized to reduce risk of infection to the patient. By disinfecting the oral cavity through bacteriostatic, bactericidal, and virucidal rinses practitioners can mitigate the risk of spreading an infection from a patient's mouth or the outside environment to other parts of their body. Prophylactic rinses are often used prior to routine dental procedures like fillings and cleaning to more invasive interventions like jaw reconstruction and tumor resection. This simple, cheap and innocuous procedure is now being used for a different purpose. In light of the COVID-19 pandemic, reduction in the spread of oral and respiratory borne viruses has become paramount in the global battle against coronavirus. Both dentists and medical providers, including ear nose throat specialists and anesthesiologists who routinely intubate patients, have implemented the use of these virucidal mouth rinses to reduce viral loads of both COVID-19 positive and non-infected patients. Dentists are particularly at risk for transmission of COVID-19 because they work directly in the oral cavity where the virus resides and the work they do creates an enormous amount of aerosols. In addition to a multitude of barrier and personal protective equipment (PPE) techniques being implemented, prior to procedures in the oral cavity patients are asked to rinse and spit different regimens of mouth rinses to reduce the chance of spreading SARS-CoV-2 to healthcare staff.
While healthcare workers have had to act quickly to respond to the pandemic and reduce the risk of spreading coronavirus, there is a lack of empirical evidence to support current practices. Here the investigators aim to address three questions; 1: Does oral prophylaxis effectively reduce oral viral load specifically of SARS-CoV-2; 2: If so for what duration is oral prophylaxis effective before viral load recovers in the oral cavity; 3: Which combination of virucidal prophylaxis if any is most effective.
- Conditions
- Covid19
- Being tested
- Water (E) Mouth rinse with the solution provided, Chlorhexidine gluconate (A) Mouth rinse with the solution provided, Hydrogen peroxide (B) Mouth rinse with the solution provided, Betadine (C) Mouth rinse with the solution provided, Alcohol mouthwash (Listerine) (D) Mouth rinse with the solution provided
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water (E) Mouth rinse with the solution providedOther
Subject will be asked to perform a simple mouth rinse for 2 minutes with one of the 5 mouth washes to be tested.
Chlorhexidine gluconate (A) Mouth rinse with the solution providedOther
Subject will be asked to perform a simple mouth rinse for 2 minutes with one of the 5 mouth washes to be tested.
Hydrogen peroxide (B) Mouth rinse with the solution providedOther
Subject will be asked to perform a simple mouth rinse for 2 minutes with one of the 5 mouth washes to be tested.
Betadine (C) Mouth rinse with the solution providedOther
Subject will be asked to perform a simple mouth rinse for 2 minutes with one of the 5 mouth washes to be tested.
Alcohol mouthwash (Listerine) (D) Mouth rinse with the solution providedOther
Subject will be asked to perform a simple mouth rinse for 2 minutes with one of the 5 mouth washes to be tested.
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine gluconate (A) | Experimental | Mouth rinse with 0.2% Chlorhexidine gluconate, Receives: Other: Chlorhexidine gluconate (A) Mouth rinse with the solution provided |
| Hydrogen peroxide (B) | Experimental | Mouth rinse with 1.5% hydrogen peroxide Receives: Other: Hydrogen peroxide (B) Mouth rinse with the solution provided |
| Betadine (C) | Experimental | Mouth rinse with betadine mouthwash, Receives: Other: Betadine (C) Mouth rinse with the solution provided |
| Mouth wash (D) | Experimental | Mouth rinse with alcohol-based mouthwash Receives: Other: Alcohol mouthwash (Listerine) (D) Mouth rinse with the solution provided |
| Water (E) | Placebo comparator | Mouth rinse with water Receives: Other: Water (E) Mouth rinse with the solution provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in oral SARS-CoV-2 load in oral cavity of COVID-19 patient using prophylactic mouth rinse
Measured: up to 2 hours post-rinse with mouthwash.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start6 Oct 2020
- Primary completion1 Jul 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan F. Bloomquist, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719208
- Sponsor's protocol ID
- [1607808
- Status last verified
- Jan 2022
- First submitted
- 21 Oct 2020
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Sars-CoV-2 Oral Viral Load With Prophylactic Mouth Rinse
- ClinicalTrials.gov ID
- NCT04719208
- Acronym / sponsor ID
- [1607808
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the effectiveness of prophylactic mouth rinses in reducing the amount of viruses, specifically SARS-CoV-2 in the oral cavity. This research will guide dental and medical providers on best practices to be performed prior to dental and medical procedures involving the oral cavity.
Detailed description
In response to SARS-CoV-2 the dental and greater healthcare communities have devised ways to combat the spread of the virus. Many dentists and physicians have advocated the use of prophylactic oral rinses for reduction of COVID-19 viral load in all patients prior to treatment in the oral pharyngeal cavity, but the effectiveness of these measures has not been validated with empirical evidence. The investigators will test COVID-19 positive hospital inpatients before and after the use of different combinations of oral rinses to provide guidance on best measures for dental or medical treatment. This research is imperative and essential as prophylactic rinses are already being used at AU and globally, without data to support their effectiveness specifically in COVID-19 positive patients.
Oral rinses have been used as an industry standard in dentistry for decades to reduce oral levels of pathogens including bacteria and viruses. According to the American Academy of Dentistry mouth rinses can be broken down into two categories, cosmetic and therapeutic. Those categorized as therapeutic include chlorhexidine, essential oils, fluoride, and hydrogen peroxide. These rinses are routinely used in both dental practices as well as in the OR setting prior to any invasive procedure involving treatment of the oral cavity. However, these mouth rinses, are typically utilized to reduce risk of infection to the patient. By disinfecting the oral cavity through bacteriostatic, bactericidal, and virucidal rinses practitioners can mitigate the risk of spreading an infection from a patient's mouth or the outside environment to other parts of their body. Prophylactic rinses are often used prior to routine dental procedures like fillings and cleaning to more invasive interventions like jaw reconstruction and tumor resection. This simple, cheap and innocuous procedure is now being used for a different purpose. In light of the COVID-19 pandemic, reduction in the spread of oral and respiratory borne viruses has become paramount in the global battle against coronavirus. Both dentists and medical providers, including ear nose throat specialists and anesthesiologists who routinely intubate patients, have implemented the use of these virucidal mouth rinses to reduce viral loads of both COVID-19 positive and non-infected patients. Dentists are particularly at risk for transmission of COVID-19 because they work directly in the oral cavity where the virus resides and the work they do creates an enormous amount of aerosols. In addition to a multitude of barrier and personal protective equipment (PPE) techniques being implemented, prior to procedures in the oral cavity patients are asked to rinse and spit different regimens of mouth rinses to reduce the chance of spreading SARS-CoV-2 to healthcare staff.
While healthcare workers have had to act quickly to respond to the pandemic and reduce the risk of spreading coronavirus, there is a lack of empirical evidence to support current practices. Here the investigators aim to address three questions; 1: Does oral prophylaxis effectively reduce oral viral load specifically of SARS-CoV-2; 2: If so for what duration is oral prophylaxis effective before viral load recovers in the oral cavity; 3: Which combination of virucidal prophylaxis if any is most effective.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine gluconate (A) | Experimental | Other: Chlorhexidine gluconate (A) Mouth rinse with the solution providedMouth rinse with 0.2% Chlorhexidine gluconate, |
| Hydrogen peroxide (B) | Experimental | Other: Hydrogen peroxide (B) Mouth rinse with the solution providedMouth rinse with 1.5% hydrogen peroxide |
| Betadine (C) | Experimental | Other: Betadine (C) Mouth rinse with the solution providedMouth rinse with betadine mouthwash, |
| Mouth wash (D) | Experimental | Other: Alcohol mouthwash (Listerine) (D) Mouth rinse with the solution providedMouth rinse with alcohol-based mouthwash |
| Water (E) | Placebo comparator | Other: Water (E) Mouth rinse with the solution providedMouth rinse with water |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject of both sexes, aged 18 years or older
- Patients who are confirmed positive for COVID-19.
- Patients currently hospitalized at Augusta University Medical Center.
- Subject voluntarily signing the informed consent document.
Key exclusion criteria (5 listed)
- Age younger than 18 years old.
- Patients that are tested negative for COVID-19
- Patient who are intubated or too sick to give consent for the study.
- Not able to speak in English or illiterate or lacking the decision-making capacity to consent for study.
- Known allergy to Listerine, Betadine or Chlorhexidine gluconate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water (E) Mouth rinse with the solution providedSubject will be asked to perform a simple mouth rinse for 2 minutes with one of the 5 mouth washes to be tested. | Other | Water (E) |
| Chlorhexidine gluconate (A) Mouth rinse with the solution providedSubject will be asked to perform a simple mouth rinse for 2 minutes with one of the 5 mouth washes to be tested. | Other | Chlorhexidine gluconate (A) |
| Hydrogen peroxide (B) Mouth rinse with the solution providedSubject will be asked to perform a simple mouth rinse for 2 minutes with one of the 5 mouth washes to be tested. | Other | Hydrogen peroxide (B) |
| Betadine (C) Mouth rinse with the solution providedSubject will be asked to perform a simple mouth rinse for 2 minutes with one of the 5 mouth washes to be tested. | Other | Betadine (C) |
| Alcohol mouthwash (Listerine) (D) Mouth rinse with the solution providedSubject will be asked to perform a simple mouth rinse for 2 minutes with one of the 5 mouth washes to be tested. | Other | Mouth wash (D) |
Primary outcome
Change in oral SARS-CoV-2 load in oral cavity of COVID-19 patient using prophylactic mouth rinse
Time frame: up to 2 hours post-rinse with mouthwash.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water (E) Mouth rinse with the solution provided, Chlorhexidine gluconate (A) Mouth rinse with the solution provided and Hydrogen peroxide (B) Mouth rinse with the solution provided in people with Covid19, run by Augusta University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in oral SARS-CoV-2 load in oral cavity of COVID-19 patient using prophylactic mouth rinse (time frame: up to 2 hours post-rinse with mouthwash.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.