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

Viral Pharyngitis Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06251089
• Other study ID #: MTH_DEN0123
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: September 2024

Study information

• Verified date: February 2024
• Source: Dentaid SL
• Contact: JUAN GISPERT, MD
• Phone: 34 935809494
• Email: joan.gispert[@]dentaid.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

Inclusion Criteria:

• Subjects admitted to nursing home

• Subjects who have had a washing period of 2 months since the last use with mouthwashes.

• > age 65

• Subjects who are able to do mouthwashes or receive oral hygiene by caregivers

• Delivery of the Participant Information Sheet (HIP) and signing of the Informed Consent (IC) to subjects or legal guardians of the subjects who agree to participate.

Exclusion Criteria:

• Subjects who are suffering from an upper or lower airway infection at the time of recruitment

• Subjects who are physically or psychologically unable to perform mouthwashes or receive oral hygiene with gauze or cotton soaked in antiseptic

• Subjects who have used oral antiseptics continuously in the past month

• Use of oral hygiene measures outside the study conditions

• Subjects who frequent residences, but are not admitted (e.g. day centre) Subjects or legal guardians of subjects who do not provide their IC to participate Subjects who have a registered allergy to the product or to the excipients of the product.

Related Conditions & MeSH terms

• Infections
• Pharyngitis
• Respiratory Tract Infections
• Viral Pharyngitis

Intervention

Drug:
• CPC mouthwash
0.07% CPC mouthwash
• Placebo
placebo of the CPC mouthwash

Locations

Country	Name	City	State
Spain	EAP Baix Llobregat	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Dentaid SL	Methodex

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence of vURTI episodes	the occurrence or non-occurrence of vURTI episodes. VURI is considered when three of the following symptoms are present: Fever over 37º; Non-productive cough; Sore throat; Rhinorrhoea; Nasal congestion; Discomfort	3 months
Secondary	description of vURTI	number of vURTI	3 months
Secondary	description of vURTI	frequency of mild, moderate or severe vURTI	3 months
Secondary	oral health	presence of gingival inflammation,	3 months
Secondary	oral health	presence of mucosal lesions	3 months
Secondary	oral health	presence of plaque	3 months