Clinical trial NCT06479226: Effect of Mouthwash in Reducing the Symptoms Associated With Flu and Cold Viruses
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2024-06-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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%.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Those participating in any other clinical study; 2. Pregnant or breastfeeding; 3. Presence a history of allergies to oral hygiene products, personal hygiene products, or their ingredients; 4. Have mouth irritation or use oral anesthetic sprays; 5. Have diabetes; 6. Be undergoing extensive dental treatment or oral surgery during the study; 7. Present immunocompromised (HIV, AIDS, immunosuppressive drug therapy); 8. Use complete dentures; 9. Do not have carpal tunnel syndrome or arthritis in the hands. 10. Participant who substantially fails to follow the required protocols; 11. Participant who fails to attend scheduled appointments; 12. Participant who is treated, during the study period, with medications that may interfere with the parameters being analyzed in the study; 13. Participant who is treated by a medical or dental service, and this may interfere with the parameters being analyzed in the study; 14. Participant who develops serious adverse reactions. 15. The participant who chooses to terminate their participation in the study; 16. Participant reports being pregnant during the study.

Primary outcomes:
measure: Upper Respiratory Symptom
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Pelotas
country: Brazil
facility: Federal University of Pelotas
state: Rio Grande Do Sul
Study officials:
References: