Recruiting

Mouthwash

Sponsor:

Ohio State University

Code:

NCT04603794

Conditions

COVID-19

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

0.5% Povidone Iodine

0.12% Chlorhexidine Gluconate Mouth Rinse

1% Hydrogen Peroxide

0.9% Normal Saline

Study Details

Brief summary:

Researchers know that the virus that causes COVID-19 has been found in the saliva (spit) of individuals who exhibit signs of the disease. Investigators would like to test the ability of three mouthwashes to reduce the levels of this virus in participants' mouths. Investigators will ask participants to use a liquid to swish around in the mouth for 30 seconds and spit it into a collection cup. Investigators will also collect spit from participants before and after participants use the mouthwash. Although participants will have no direct benefits from the study, investigators will gain a wealth of information that would benefit patients who are at risk for COVID-19.

Conditions

COVID-19

Study ID

NCT04603794

Start date

Oct 1, 2020

Status verified date

Oct, 2020

Completion date

Nov, 2020

Anticipated

Primary completion date

Nov, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. adults age 18-80 admitted to The Ohio State University Medical Center,
2. diagnosis of COVID-19 confirmed by Polymerase Chain Reaction (PCR),
3. salivary carriage of COVID-19 virus
4. ability to perform mouthwash rinses and to expectorate.

Exclusion Criteria:

1. allergy to any study mouth rinse,
2. active uncontrolled thyroid disease,
3. pregnancy
4. patients undergoing radioactive iodine therapy.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: 1% Hydrogen Peroxide Mouth Rinse

30 second oral rinse with 1% Hydrogen Peroxide

active comparator: 0.12% Chlorhexidine Gluconate Mouth Rinse

30 second oral rinse with 0.12% Chlorhexidine Gluconate

active comparator: 0.5% Povidone Iodine Mouth Rinse

30 second oral rinse with 0.5% Povidone Iodine Mouth wash

placebo comparator: 0.9% Normal Saline Mouth Rinse

30 second oral rinse with 0.9% Normal Saline

Interventions

0.5% Povidone Iodine

Commercially Available Mouth Rinses and Over the Counter Standard Formulations

0.12% Chlorhexidine Gluconate Mouth Rinse

Commercially Available Mouth Rinses

1% Hydrogen Peroxide

Commercially Available Over the Counter Standard Formulations USP (United States Pharmacopeia)

0.9% Normal Saline

Commercially Available Over the Counter Standard Formulations USP (United States Pharmacopeia)

Primary outcome measure

  • real time reverse transcriptase quantitative PCR [ Time Frame: 3 measurements of changes from times 0 minutes. vs:15 minutes, and vs: 45 minutes during a single session ]
  • ct values [ Time Frame: 3 measurements of changes from times 0 minutes.vs:15 minutes, and vs:45 minutes during a single session ]

Central Contacts and Locations

Central contacts

David L Hall, DDS

614-292-2622hall.611@osu.edu

Purnima Kumar, PhD,DDS

614-804-2112kumar.83@osu.edu

Locations

The Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

David L Hall, DDS

614-292-2622hall.611@osu.edu

Purnima Kumar, PhD,DDS

614-804-2112kumar.83@osu.edu

More Information

Sponsor

Ohio State University

Last update posted

Oct 27, 2020

Last verified

Oct, 2020

Keywords

  • Mouthwashes
  • COVID-19
  • Salivary Carriage
  • Povidone-Iodine
  • PCR (Polymerase Chain Reaction)
  • Dental Aerosols

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Ohio State University on 2020-10-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.