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

NCT06251089 | Completed

• 1 other identifier: MTH_DEN0123
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Viral Pharyngitis

Keywords

CPC; viral upper-respiratory infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• description of vURTI

  3 months

• description of vURTI

  3 months

• oral health

  3 months

• oral health

  3 months

• oral health

  3 months

Study Arms (2)

0.07% CPC mouthwash

EXPERIMENTAL

Brush your teeth twice a day with fluoride toothpaste, after meals. Then rinse for 1 minute with 15 ml of the test mouthwash for 1 minute. If feasible on the part of the volunteer, they will be asked to do 30 seconds of gargling and 30 seconds of mouthwash. If the volunteers are unable to rinse, the health professionals who care for them will be asked to perform the application of the product using sterile gauze soaked with the product, passing it through the oral mucous membranes and tongue, twice a day

Drug: CPC mouthwash

comparator

PLACEBO COMPARATOR

Brush your teeth twice a day with fluoride toothpaste, after meals. Then rinse for 1 minute with 15 ml of the control product for 1 minute. If feasible on the part of the volunteer, they will be asked to do 30 seconds of gargling and 30 seconds of mouthwash. If the volunteers are unable to rinse, the health professionals who care for them will be asked to perform the application of the product using sterile gauze soaked with the product, passing it through the oral mucous membranes and tongue, twice a day

Drug: Placebo

Interventions

CPC mouthwash DRUG

0.07% CPC mouthwash

0.07% CPC mouthwash

Placebo DRUG

placebo of the CPC mouthwash

comparator

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dentaid SL: lead
• Methodex: collaborator

Study Sites (1)

EAP Baix Llobregat

Barcelona, Spain

Location

Study Officials

• Vanessa Blanc

  Dentaid SL

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: February 9, 2024
• Study Start: November 15, 2023
• Primary Completion: August 5, 2024
• Study Completion: August 5, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)