Clinical trial NCT06251089: Effect of Cetylpyridinium Chloride (CPC) Rinse in Viral Upper Respiratory Tract Infections (vURTI)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Viral Pharyngitis
Keywords: CPC
viral upper-respiratory infections
Lead sponsor: Dentaid SL
Sponsor class: INDUSTRY
Collaborators: name: Methodex
First posted: 2024-02-09
Enrollment: 102
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Eligibility criteria: 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.

Primary outcomes:
measure: occurrence of vURTI episodes
timeFrame: 3 months
Secondary outcomes:
measure: description of vURTI
timeFrame: 3 months
measure: description of vURTI
timeFrame: 3 months
measure: oral health
timeFrame: 3 months
measure: oral health
timeFrame: 3 months
measure: oral health
timeFrame: 3 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: EAP Baix Llobregat
Study officials:
affiliation: Dentaid SL
name: Vanessa Blanc
role: STUDY_CHAIR
References: