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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

Other trials in United States

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 groups in NCT04719208
Study groupRoleWhat they receive
Chlorhexidine gluconate (A)ExperimentalMouth rinse with 0.2% Chlorhexidine gluconate,
Receives: Other: Chlorhexidine gluconate (A) Mouth rinse with the solution provided
Hydrogen peroxide (B)ExperimentalMouth rinse with 1.5% hydrogen peroxide
Receives: Other: Hydrogen peroxide (B) Mouth rinse with the solution provided
Betadine (C)ExperimentalMouth rinse with betadine mouthwash,
Receives: Other: Betadine (C) Mouth rinse with the solution provided
Mouth wash (D)ExperimentalMouth rinse with alcohol-based mouthwash
Receives: Other: Alcohol mouthwash (Listerine) (D) Mouth rinse with the solution provided
Water (E)Placebo comparatorMouth 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.

  1. 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.

  1. First posted22 Jan 2021
  2. Study start6 Oct 2020
  3. Primary completion1 Jul 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

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)
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

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.

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