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

NCT06479226 | Completed Phase 3

• 1 other identifier: CRO-2022-04-FLU-REG-BZ-ZM
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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, 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

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days

Study Arms (2)

Control

NO INTERVENTION

Toothbrushing alone

cetylpyridinium chloride (0.075%) and zinc alcohol free mouthwash

EXPERIMENTAL

Toothbrushing + mouthrinse

Drug: cetylpyridinium chloride (0.075%) and zinc alcohol free mouthwash

Interventions

cetylpyridinium chloride (0.075%) and zinc alcohol free mouthwash DRUG

mouthrinse

cetylpyridinium chloride (0.075%) and zinc alcohol free mouthwash

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Federal University of Pelotas

Pelotas, Rio Grande do Sul, Brazil

Location

Related Publications (1)

• 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.

  PMID: 40009628 DERIVED

MeSH Terms

Interventions

Cetylpyridinium; Zinc; Ethanol

Intervention Hierarchy (Ancestors)

Pyridinium Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Alcohols; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 28, 2024
• Study Start: June 5, 2022
• Primary Completion: October 6, 2022
• Study Completion: October 6, 2022
• Last Updated: March 18, 2026

Record last verified: 2024-06

Locations

BR (1)