Official Title
Reduction of Sars-CoV-2 Oral Viral Load With Prophylactic Mouth Rinse
Brief 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.

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.

Active, not recruiting
COVID19

Other: Water (E) Mouth rinse with the solution provided

Subject 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) Mouth rinse with the solution provided

Subject 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) Mouth rinse with the solution provided

Subject 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) Mouth rinse with the solution provided

Subject will be asked to perform a simple mouth rinse for 2 minutes with one of the 5 mouth washes to be tested.

Other: Alcohol mouthwash (Listerine) (D) Mouth rinse with the solution provided

Subject will be asked to perform a simple mouth rinse for 2 minutes with one of the 5 mouth washes to be tested.

Eligibility Criteria

Inclusion Criteria:

1. Subject of both sexes, aged 18 years or older

2. Patients who are confirmed positive for COVID-19.

3. Patients currently hospitalized at Augusta University Medical Center.

4. Subject voluntarily signing the informed consent document.

Exclusion Criteria:

1. Age younger than 18 years old.

2. Patients that are tested negative for COVID-19

3. Patient who are intubated or too sick to give consent for the study.

4. Not able to speak in English or illiterate or lacking the decision-making capacity to
consent for study.

5. Known allergy to Listerine, Betadine or Chlorhexidine gluconate

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Augusta University
Augusta, Georgia, United States

Augusta University-Dental College of Georgia
Augusta, Georgia, United States

Augusta University
NCT Number
MeSH Terms
COVID-19
Chlorhexidine
Chlorhexidine gluconate
Hydrogen Peroxide
Povidone-Iodine
Listerine
Pharmaceutical Solutions