Covid19Phase 3NCT04864925
Measurement of Viral Load Reduction in the Oral Cavity After a Regimental Use of OC Toothpaste Products
A Phase 3 study testing Colgate Total Clean Mint and Tom's Botanically Bright Peppermint in people with Covid19, run by Colgate Palmolive at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Covid19
- What is being tested?
- Colgate Total Clean Mint and Tom's Botanically Bright Peppermint
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2020to 25 Aug 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Enrolled subjects between the ages of 18-64 and have tested positive for Covid19.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers University Hospital
Newark, New Jersey, 07103
About this study
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.
Read the 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
- Being tested
- Colgate Total Clean Mint, Tom's Botanically Bright Peppermint
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colgate Total Clean MintDrug
Also called Toothpaste
2 minutes of whole mouth toothbrushing
Tom's Botanically Bright PeppermintDrug
Also called Toothpaste
2 minutes of whole mouth toothbrushing
| Study group | Role | What they receive |
|---|---|---|
| Colgate Total Clean Mint | Experimental | Brush with toothpaste for a minimum of 2 minutes Receives: Drug: Colgate Total Clean Mint |
| Tom's Botanically Bright Peppermint | Active comparator | Brush with toothpaste for a minimum of 2 minutes Receives: Drug: Tom's Botanically Bright Peppermint |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 60 minutes after brushing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start28 Dec 2020
- Primary completion25 Aug 2021
- Study completion25 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Colgate PalmoliveThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864925
- Sponsor's protocol ID
- EXT-SARS2-COV2-OC-RUT-CD
- Status last verified
- Jan 2022
- First submitted
- 25 Apr 2021
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Viral Load Reduction in the Oral Cavity After a Regimental Use of OC Toothpaste Products
- ClinicalTrials.gov ID
- NCT04864925
- Acronym / sponsor ID
- EXT-SARS2-COV2-OC-RUT-CD
- Conditions
- Covid19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2020 (actual)
- Primary completion
- 25 Aug 2021 (actual)
- Study completion
- 25 Aug 2021 (actual)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colgate Total Clean Mint | Experimental | Drug: Colgate Total Clean MintBrush with toothpaste for a minimum of 2 minutes |
| Tom's Botanically Bright Peppermint | Active comparator | Drug: Tom's Botanically Bright PeppermintBrush with toothpaste for a minimum of 2 minutes |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Enrolled subjects between the ages of 18-64 and have tested positive for Covid19.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colgate Total Clean MintAlso: Toothpaste2 minutes of whole mouth toothbrushing | Drug | Colgate Total Clean Mint |
| Tom's Botanically Bright PeppermintAlso: Toothpaste2 minutes of whole mouth toothbrushing | Drug | Tom's Botanically Bright Peppermint |
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colgate Total Clean Mint and Tom's Botanically Bright Peppermint in people with Covid19, run by Colgate Palmolive at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome based on reductions of viral titers in the oral cavity as determined by qRT-PCR (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.