[COVID-19] Reduction of Sars-CoV-2 Oral Viral Load With Prophylactic Mouth Rinse

January 31, 2022 updated by: Ryan F. Bloomquist, Augusta University

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30901
        • Augusta University
      • Augusta, Georgia, United States, 30912
        • Augusta University-Dental College of Georgia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chlorhexidine gluconate (A)
Mouth rinse with 0.2% Chlorhexidine gluconate,
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.
Experimental: Hydrogen peroxide (B)
Mouth rinse with 1.5% hydrogen peroxide
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.
Experimental: Betadine (C)
Mouth rinse with betadine mouthwash,
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.
Experimental: Mouth wash (D)
Mouth rinse with alcohol-based mouthwash
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.
Placebo Comparator: Water (E)
Mouth rinse with water
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
up to 2 hours post-rinse with mouthwash.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Augusta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2020

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

October 21, 2020

First Submitted That Met QC Criteria

January 20, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

February 1, 2022

Last Update Submitted That Met QC Criteria

January 31, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • [1607808

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Clinical Trials on Chlorhexidine gluconate (A) Mouth rinse with the solution provided

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe