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Completed

NCT Number: NCT04931004

Oral Rinse to Reduced Expelled Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) During COVID-19 Infection

Prospective, cross-sectional study evaluating the effect of commercially available mouthwashes on expelled/exhaled SARS-CoV-2 viral load using face mask sampling.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University Hospital

Newark, New Jersey, 07103, United States

About this study

The study will consist of a Control Phase to optimize procedures for measuring expelled/exhaled viral load, and a Evaluation phase comparing different commercially available mouthwashes.

In the Control Phase. up to 20 COVID-19 patients will be asked to undergo a sequence of face mask sampling and saliva collections prior to and after an oral rinse with (i) water and (ii) a commercially-available cetylpyridinium chloride (CPC) mouthwash.

Based on outcomes of the Control Phase, the study will proceed into the Evaluation Phase, which will randomize approximately 40 COVID-19 patients to receive 1 of 4 commercially available Colgate mouthwashes following standard package instructions. Face mask sampling and saliva will be collected prior to and after the mouth rinse to assess impact on SARS-CoV-2 viral load.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18
  • Able to provide consent
  • Polymerase chain reaction (PCR)-confirmed SARS-CoV-2 within previous 48 hours.

Exclusion criteria

  • Clinical contraindication or poor feasibility to complete study procedures
  • Unwilling or unable to produce saliva or face mask samples
  • Unable to produce at least 500 microliters of saliva.
  • Eaten within past 30 minutes
  • Known allergy to mouthwash products

Treatment and study plan

Mouthwash Product

Drug

Commercially over-the-counter Colgate mouthwashes will be administered according to standard package instructions. Viral load will be measured prior to and after mouth rinse using serial face mask and saliva samples. Additionally viral load measured prior to and after water rinse using serial face mask and saliva samples. These serial measurements and both CPC and water rinses were conducted consecutively in one visit.

Other names: water rinse

Primary outcomes

  1. Control Phase - Primary Endpoint

    Time frame: Single timepoint, ~1 hour

    Reduction in viral load by face mask sampling from pre-intervention to 0-15 with CPC versus water rinse control

  2. Evaluation Phase - Primary Endpoint

    Time frame: Single timepoint, ~1.5 hours

    Reduction in viral load by face mask sampling from pre-intervention to 45-60 minutes versus water rinse control

Secondary outcomes

  1. Evaluation Phase - Secondary Endpoint

    Time frame: Single timepoint, ~1 hour

    Reduction in viral load by face mask sampling from pre-intervention to 0-15 and15-30 minutes of oral rinse products versus water rinse control

  2. Comparative Saliva Reduction

    Time frame: Single timepoint, ~1.5 hours

    Reduction in viral load in saliva pre-intervention to 30 and 60 minutes post-intervention.

Other outcomes

  1. Influence of Speaking

    Time frame: Single timepoint, ~1 hour

    Difference in viral load by face mask sampling with speaking versus not speaking

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • Colgate Palmolive
  • University of Leicester

Registry information

Official study title

Effect of Oral Hygiene Products on Reducing Expelled/Exhaled SARS-CoV-2

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 18, 2021
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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