Viral PharyngitisNCT06251089
Effect of Cetylpyridinium Chloride (CPC) Rinse in Viral Upper Respiratory Tract Infections (vURTI)
A study testing CPC mouthwash in people with Viral Pharyngitis, run by Dentaid SL at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Viral Pharyngitis
- What is being tested?
- CPC mouthwash
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteSpain
- Study dates
- 15 Nov 2023to 5 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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
- Conditions
- Viral Pharyngitis
- Being tested
- CPC mouthwash, Placebo
- Keywords
- CPC, viral upper-respiratory infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPC mouthwashDrug
0.07% CPC mouthwash
PlaceboDrug
placebo of the CPC mouthwash
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (5)
description of vURTI
number of vURTI
Measured: 3 months
description of vURTI
frequency of mild, moderate or severe vURTI
Measured: 3 months
oral health
presence of gingival inflammation,
Measured: 3 months
oral health
presence of mucosal lesions
Measured: 3 months
oral health
presence of plaque
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start15 Nov 2023
- Primary completion5 Aug 2024
- Study completion5 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral PharyngitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dentaid SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Methodex
- Responsible party
- Sponsor
- Investigators
- Vanessa Blanc, Study chair, Dentaid SL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251089
- Sponsor's protocol ID
- MTH_DEN0123
- Status last verified
- Feb 2024
- First submitted
- 8 Jan 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06251089
- Acronym / sponsor ID
- MTH_DEN0123
- Conditions
- Viral Pharyngitis
- Keywords
- CPC, viral upper-respiratory infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Dentaid SLIndustry (pharma, biotech, devices)
- Collaborators
- Methodex
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 5 Aug 2024 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.07% CPC mouthwash | Experimental | Drug: CPC mouthwashBrush 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 |
| comparator | Placebo comparator | Drug: PlaceboBrush 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 |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPC mouthwash0.07% CPC mouthwash | Drug | 0.07% CPC mouthwash |
| Placeboplacebo of the CPC mouthwash | Drug | comparator |
Primary outcome
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
5 secondary outcomes
description of vURTI
Time frame: 3 months
description of vURTI
Time frame: 3 months
oral health
Time frame: 3 months
oral health
Time frame: 3 months
oral health
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanessa Blanc study chair
Dentaid SL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPC mouthwash in people with Viral Pharyngitis, run by Dentaid SL at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of vURTI episodes (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.