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

NCT ID: NCT04864925

Last Updated: 2022-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-28
• Study Completion Date: 2021-08-25

Brief Summary

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.

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

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Colgate Total Clean Mint

Brush with toothpaste for a minimum of 2 minutes

Group Type: EXPERIMENTAL

Colgate Total Clean Mint

Intervention Type: DRUG

2 minutes of whole mouth toothbrushing

Tom's Botanically Bright Peppermint

Brush with toothpaste for a minimum of 2 minutes

Group Type: ACTIVE_COMPARATOR

Tom's Botanically Bright Peppermint

Intervention Type: DRUG

2 minutes of whole mouth toothbrushing

Interventions

Colgate Total Clean Mint

2 minutes of whole mouth toothbrushing

Intervention Type: DRUG

Tom's Botanically Bright Peppermint

2 minutes of whole mouth toothbrushing

Intervention Type: DRUG

Other Intervention Names

Toothpaste; Toothpaste

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Colgate Palmolive

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rutgers University Hospital

Newark, New Jersey, United States

Countries

United States

Other Identifiers

EXT-SARS2-COV2-OC-RUT-CD

Identifier Type: -

Identifier Source: org_study_id