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 inreducing the amount of viruses, specifically SARS-CoV-2 in the oral cavity. This researchwill guide dental and medical providers on best practices to be performed prior to dentaland 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.

Unknown status
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