Skip to main content
OpenTrials
Completed

NCT Number: NCT06251089

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EAP Baix Llobregat

Barcelona, Spain

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CPC mouthwash

Drug

0.07% CPC mouthwash

Placebo

Drug

placebo of the CPC mouthwash

Primary outcomes

  1. occurrence of vURTI episodes

    Time frame: 3 months

    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

Secondary outcomes

  1. description of vURTI

    Time frame: 3 months

    number of vURTI

  2. description of vURTI

    Time frame: 3 months

    frequency of mild, moderate or severe vURTI

  3. oral health

    Time frame: 3 months

    presence of gingival inflammation,

  4. oral health

    Time frame: 3 months

    presence of mucosal lesions

  5. oral health

    Time frame: 3 months

    presence of plaque

Sponsors and collaborators

Lead sponsor

Dentaid SL

Industry

Collaborators

  • Methodex

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 9, 2024
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.