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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Drug: Colgate Total Clean Mint; Drug: Tom's Botanically Bright Peppermint

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • Rutgers University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Colgate Total Clean Mint; Brush with toothpaste for a minimum of 2 minutes	Drug: Colgate Total Clean Mint; 2 minutes of whole mouth toothbrushing; Other Names: Toothpaste
Active Comparator: Tom's Botanically Bright Peppermint; Brush with toothpaste for a minimum of 2 minutes	Drug: Tom's Botanically Bright Peppermint; 2 minutes of whole mouth toothbrushing; Other Names: Toothpaste

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary outcome based on reductions of viral titers in the oral cavity as determined by qRT-PCR	Primary outcome based on reductions of viral titers in the oral cavity as determined by qRT-PCR	Baseline
Primary outcome based on reductions of viral titers in the oral cavity as determined by qRT-PCR	Primary outcome based on reductions of viral titers in the oral cavity as determined by qRT-PCR	30 minutes after brushing
Primary outcome based on reductions of viral titers in the oral cavity as determined by qRT-PCR	Primary outcome based on reductions of viral titers in the oral cavity as determined by qRT-PCR	60 minutes after brushing

Collaborators and Investigators

• Sponsor: Colgate Palmolive

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2020
• Primary Completion (Actual): August 25, 2021
• Study Completion (Actual): August 25, 2021

Study Registration Dates

• First Submitted: April 25, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 29, 2021

Study Record Updates

• Last Update Posted (Actual): January 18, 2022
• Last Update Submitted That Met QC Criteria: January 13, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: EXT-SARS2-COV2-OC-RUT-CD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No