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

• ClinicalTrials.gov Identifier: NCT04719208
• Recruitment Status: Active, not recruiting
• First Posted: January 22, 2021
• Last Update Posted: February 1, 2022
• Sponsor: Augusta University
• Information provided by (Responsible Party): Ryan F. Bloomquist, Augusta University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Covid19	Other: Water (E) Mouth rinse with the solution provided; Other: Chlorhexidine gluconate (A) Mouth rinse with the solution provided; Other: Hydrogen peroxide (B) Mouth rinse with the solution provided; Other: Betadine (C) Mouth rinse with the solution provided; Other: Alcohol mouthwash (Listerine) (D) Mouth rinse with the solution provided	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Reduction of Sars-CoV-2 Oral Viral Load With Prophylactic Mouth Rinse
• Actual Study Start Date: October 6, 2020
• Estimated Primary Completion Date: July 1, 2023
• Estimated Study Completion Date: December 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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. ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Georgia

Augusta University

Augusta, Georgia, United States, 30901

Augusta University-Dental College of Georgia

Augusta, Georgia, United States, 30912

Sponsors and Collaborators

Augusta University

More Information

• Responsible Party: Ryan F. Bloomquist, Assistant Professor, Augusta University
• ClinicalTrials.gov Identifier: NCT04719208
• Other Study ID Numbers: [1607808
• First Posted: January 22, 2021
• Last Update Posted: February 1, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Chlorhexidine; Chlorhexidine gluconate; Hydrogen Peroxide; Povidone-Iodine; Listerine; Pharmaceutical Solutions; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Dermatologic Agents