HealthyPhase 3NCT06479226
Effect of Mouthwash in Reducing the Symptoms Associated With Flu and Cold Viruses
A Phase 3 study testing cetylpyridinium chloride (0.075%) and zinc alcohol free mouthwash in people with Healthy, run by Colgate Palmolive at 1 site in Brazil.
Trial summary
The aim of this study will be to evaluate the efficacy of regular cleaning of the oropharynx (via gargling) on the incidence of symptoms associated with flu and colds. The working hypothesis is that there will be a significant reduction in symptoms associated with flu and colds after using the mouthwash product… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- cetylpyridinium chloride (0.075%) and zinc alcohol free mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Jun 2022to 6 Oct 2022
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Good systemic general health as determined by study investigators; Availability of 90 days to participate in the study;
Who cannot join
- those participating in any other clinical study;
- Pregnant or breastfeeding;
- Presence a history of allergies to oral hygiene products, personal hygiene products, or their ingredients;
- Have mouth irritation or use oral anesthetic sprays;
- Have diabetes;
- Be undergoing extensive dental treatment or oral surgery during the study;
Show all 16Show fewer
- Present immunocompromised (HIV, AIDS, immunosuppressive drug therapy);
- Use complete dentures;
- Do not have carpal tunnel syndrome or arthritis in the hands.
- Participant who substantially fails to follow the required protocols;
- Participant who fails to attend scheduled appointments;
- Participant who is treated, during the study period, with medications that may interfere with the parameters being analyzed in the study;
- Participant who is treated by a medical or dental service, and this may interfere with the parameters being analyzed in the study;
- Participant who develops serious adverse reactions.
- The participant who chooses to terminate their participation in the study;
- Participant reports being pregnant during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Cetylpyridinium Chloride and Zinc Mouthwash in Reducing the Occurrence of Symptoms Associated With the Flu and Cold Season - a Randomized Clinical Trial
The aim of this study will be to evaluate the efficacy of regular cleaning of the oropharynx (via gargling) on the incidence of symptoms associated with flu and colds. The working hypothesis is that there will be a significant reduction in symptoms associated with flu and colds after using the mouthwash product, compared to the experimental control regime. A total of 150 individuals will be randomized to one of the two experimental regimens and followed for a period of 90 days. The experimental regimen consists of toothbrushing followed by gargling with a cetylpyridinium chloride (CPC) (0.075%) and zinc containing alcohol free rinse and the control regimen consists of toothbrushing alone. Participants will be instructed to brush their teeth twice a day for two minutes. Those allocated to the test regime will gargle with 20 ml of the mouthwash after each brushing. At the initial visit, participants will receive the products and instructions for use, as well as a daily log questionnaire. Participants will be asked to send their daily records once a week, using a messaging application. The proportion of days without any of the evaluated symptoms will be used as the main outcome. In addition, soft and hard tissue exams will be performed at the initial consultation, after 30 and 90 days of follow-up by a blinded researcher. Potential adverse events will be collected throughout the study. The groups will be compared using the chi-square test and one-way analysis of variance (ANOVA) will be used to compare the treatment group symptom rates between groups. The significance level will be set at 95%.
- Conditions
- Healthy
- Being tested
- cetylpyridinium chloride (0.075%) and zinc alcohol free mouthwash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cetylpyridinium chloride (0.075%) and zinc alcohol free mouthwashDrug
mouthrinse
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Toothbrushing alone |
| cetylpyridinium chloride (0.075%) and zinc alcohol free mouthwash | Experimental | Toothbrushing + mouthrinse Receives: Drug: cetylpyridinium chloride (0.075%) and zinc alcohol free mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Respiratory Symptom
any upper respiratory system associated with colds and flu according to the Wisconsin Upper Respiratory Symptom Survey (WURSS-21) Daily Symptom Report.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start5 Jun 2022
- Primary completion6 Oct 2022
- Study completion6 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 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
- NCT06479226
- Sponsor's protocol ID
- CRO-2022-05-FLU-PEL-BZ-ZM
- Status last verified
- Jun 2024
- First submitted
- 24 Jun 2024
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Muniz FWMG, Casarin M, Pola NM, Rosing CK, Silveira TMD, Silva FH, de Holanda GA, de Oliveira LV, Dantas PPA, Stewart B, Malheiros Z, Benitez C, Schaeffer L. Efficacy of regular gargling with a cetylpyridinium chloride plus zinc containing mouthwash can reduce upper respiratory symptoms. PLoS One. 2025 Feb 26;20(2):e0316807. doi: 10.1371/journal.pone.0316807. eCollection 2025.
PubMed 40009628
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cetylpyridinium Chloride and Zinc Mouthwash in Reducing the Occurrence of Symptoms Associated With the Flu and Cold Season - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06479226
- Acronym / sponsor ID
- CRO-2022-05-FLU-PEL-BZ-ZM
- Conditions
- Healthy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2022 (actual)
- Primary completion
- 6 Oct 2022 (actual)
- Study completion
- 6 Oct 2022 (actual)
- First posted
- 28 Jun 2024 (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.
The aim of this study will be to evaluate the efficacy of regular cleaning of the oropharynx (via gargling) on the incidence of symptoms associated with flu and colds. The working hypothesis is that there will be a significant reduction in symptoms associated with flu and colds after using the mouthwash product, compared to the experimental control regime. A total of 150 individuals will be randomized to one of the two experimental regimens and followed for a period of 90 days. The experimental regimen consists of toothbrushing followed by gargling with a cetylpyridinium chloride (CPC) (0.075%) and zinc containing alcohol free rinse and the control regimen consists of toothbrushing alone. Participants will be instructed to brush their teeth twice a day for two minutes. Those allocated to the test regime will gargle with 20 ml of the mouthwash after each brushing. At the initial visit, participants will receive the products and instructions for use, as well as a daily log questionnaire. Participants will be asked to send their daily records once a week, using a messaging application. The proportion of days without any of the evaluated symptoms will be used as the main outcome. In addition, soft and hard tissue exams will be performed at the initial consultation, after 30 and 90 days of follow-up by a blinded researcher. Potential adverse events will be collected throughout the study. The groups will be compared using the chi-square test and one-way analysis of variance (ANOVA) will be used to compare the treatment group symptom rates between groups. The significance level will be set at 95%.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Toothbrushing alone |
| cetylpyridinium chloride (0.075%) and zinc alcohol free mouthwash | Experimental | Drug: cetylpyridinium chloride (0.075%) and zinc alcohol free mouthwashToothbrushing + mouthrinse |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Good systemic general health as determined by study investigators; Availability of 90 days to participate in the study;
Key exclusion criteria (16 listed)
- those participating in any other clinical study;
- Pregnant or breastfeeding;
- Presence a history of allergies to oral hygiene products, personal hygiene products, or their ingredients;
- Have mouth irritation or use oral anesthetic sprays;
- Have diabetes;
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 |
|---|---|---|
| cetylpyridinium chloride (0.075%) and zinc alcohol free mouthwashmouthrinse | Drug | cetylpyridinium chloride (0.075%) and zinc alcohol free mouthwash |
Primary outcome
Upper Respiratory Symptom
Time frame: 90 days
any upper respiratory system associated with colds and flu according to the Wisconsin Upper Respiratory Symptom Survey (WURSS-21) Daily Symptom Report.
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 7 Oct 2026.
- Derived from this study: PubMed 40009628Muniz FWMG, Casarin M, Pola NM, Rosing CK, Silveira TMD, Silva FH, de Holanda GA, de Oliveira LV, Dantas PPA, Stewart B, Malheiros Z, Benitez C, Schaeffer L. Efficacy of regular gargling with a cetylpyridinium chloride plus zinc containing mouthwash can reduce upper respiratory symptoms. PLoS One. 2025 Feb 26;20(2):e0316807. doi: 10.1371/journal.pone.0316807. eCollection 2025.
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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 cetylpyridinium chloride (0.075%) and zinc alcohol free mouthwash in people with Healthy, run by Colgate Palmolive at 1 site in Brazil.
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 16 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 7 Oct 2026. 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 Brazil. 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?
Upper Respiratory Symptom (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06479226, which also lists 1 linked publication.
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 7 Oct 2026.