Effect of Mouthwash in Reducing the Symptoms Associated With Flu and Cold Viruses

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%.

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Key information

Conditions

Healthy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Federal University of Pelotas

Pelotas, Rio Grande do Sul, Brazil

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Good systemic general health as determined by study investigators; Availability of 90 days to participate in the study;

Exclusion criteria

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;
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.

Treatment and study plan

cetylpyridinium chloride (0.075%) and zinc alcohol free mouthwash

Drug

mouthrinse

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study 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

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Jun 28, 2024
Registry last updated: Mar 18, 2026

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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