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| Name | Class |
|---|---|
| Methodex | INDUSTRY |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPC mouthwash | Drug | 0.07% CPC mouthwash |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| description of vURTI | number of vURTI | 3 months |
| description of vURTI | frequency of mild, moderate or severe vURTI | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vanessa Blanc | Dentaid SL | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EAP Baix Llobregat | Barcelona | Spain |
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| Drug |
placebo of the CPC mouthwash |
|
| oral health | presence of gingival inflammation, | 3 months |
| oral health | presence of mucosal lesions | 3 months |
| oral health | presence of plaque | 3 months |