CompletedNot Applicable

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

Spain102 participantsStarted 2023-11-15

Plain-language 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.

Who can participate

Age range65 Years – 100 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

occurrence of vURTI episodes

Timeframe: 3 months

Trial details

NCT IDNCT06251089

SponsorDentaid SL

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-05