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OpenTrials
Completed

NCT Number: NCT04864925

Measurement of Viral Load Reduction in the Oral Cavity After a Regimental Use of OC Toothpaste Products

SARS COVID 2 has caused a pandemic of proportions unparalleled in the past 100 years. The virus has an uncanny ability for transmission and as such has been difficult to control. The spread of the virus has affected everything from education, business, politics and survival. While the investigators have learned a great deal in the last 9 months they still face an uncertain day to day existence. Health care workers are particularly vulnerable to transmission of this virus because of their close contact with patients. Moreover, dentists are particularly vulnerable because the virus is spread via aerosols which are generated quite easily in the dental office putting dentists and their associates at risk. The oral cavity appears to be a likely domain for viral carriage particularly since both taste and smell are hallmark effects of the virus. With these issues at hand it will be of great advantage to have a simple routine oral hygiene method in the effort to reduce the oral viral load. There is some reason to expect that oral hygiene procedures with known anti-microbial effects could have some use in our efforts to reduce or control the oral viral load. With this issue in mind investigators feel that stannous fluoride could modify the virus in such a manner as to effectively reduce the oral viral load.

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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–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rutgers University Hospital

Newark, New Jersey, 07103, United States

About this study

Study will measure reduction of SARS-CoV-2 levels in the oral cavity after brushing for up to an hour. Subject sampling will occur at baseline, 15 min, 30 min, and 60 min

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Enrolled subjects between the ages of 18-64 and have tested positive for Covid19.

Exclusion criteria

-

Treatment and study plan

Colgate Total Clean Mint

Drug

2 minutes of whole mouth toothbrushing

Other names: Toothpaste

Tom's Botanically Bright Peppermint

Drug

2 minutes of whole mouth toothbrushing

Other names: Toothpaste

Primary outcomes

  1. Primary outcome based on reductions of viral titers in the oral cavity as determined by qRT-PCR

    Time frame: Baseline

    Primary outcome based on reductions of viral titers in the oral cavity as determined by qRT-PCR

  2. Primary outcome based on reductions of viral titers in the oral cavity as determined by qRT-PCR

    Time frame: 30 minutes after brushing

    Primary outcome based on reductions of viral titers in the oral cavity as determined by qRT-PCR

  3. Primary outcome based on reductions of viral titers in the oral cavity as determined by qRT-PCR

    Time frame: 60 minutes after brushing

    Primary outcome based on reductions of viral titers in the oral cavity as determined by qRT-PCR

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 29, 2021
Registry last updated
Jan 18, 2022

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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