NCT06251089

Effect of Cetylpyridinium Chloride (CPC) Rinse in Viral Upper Respiratory Tract Infections (vURTI)

Randomized, Double-blind, Multicenter Pilot Clinical Trial to Evaluate the Use of a Mouthwash With Cetylpyridinium Chloride (CPC) in the Prevention and Reduction of Symptoms of Viral Upper Respiratory Tract Infections (vURTI)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Dentaid SL · Industry
• Sex: All
• Age: 65 Years – 100 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, controlled clinical trial with two parallel groups in which 150 volunteers (75 per group) will receive either VITIS CPC Protect® mouthwash (Mouthwash with cetylpyridinium chloride (CPC) as an anti-plaque antiseptic at a concentration of 0.07%) or mouthwash without cetylpyridinium chloride, as control group Subjects included in the study will be followed for 90 days. Symptoms associated with vURTIs (viral upper respiratory tract infections) should be recorded, when they appear, to determine the existence of viral infections of the upper respiratory tract. Symptoms and adverse effects will be recorded when the episode occurs. The assignment as VURIs will be made by the investigator once the diaries have been completed, or during the symptoms if possible.

Detailed description

This is a randomized, controlled clinical trial with two parallel groups in which 150 volunteers (75 per group) will be included. Allocation ratio (1:1). The trial will be offered to subjects who live in a nursing home and who can perform mouthwashes themselves or to whom healthcare professionals can apply the product. Subjects included in the study will be followed for 90 days. Symptoms associated with vURTI should be recorded, when they appear, to determine the existence of viral infections of the upper respiratory tract. If such an infection exists (when three of the following symptoms are present: fever over 37º, non-productive cough, sore throat, runny nose, nasal congestion or malaise) the degree of severity will be determined and recorded. Symptoms and adverse effects will be recorded when the episode occurs. The assignment as vURTI will be made by the investigator once the diaries have been completed, or during the symptoms if possible. Follow-up visits will be conducted fortnightly

Conditions

• Viral Pharyngitis

Interventions

Type	Name	Description
DRUG	CPC mouthwash	0.07% CPC mouthwash
DRUG	Placebo	placebo of the CPC mouthwash

Timeline

• Start date: 2023-11-15
• Primary completion: 2024-08-05
• Completion: 2024-08-05
• First posted: 2024-02-09
• Last updated: 2024-08-07

Locations

1 site across 1 country: Spain