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| Column | Value |
|---|---|
| Trial registration number | NCT04902976 |
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Full text link
Last imported at : May 28, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
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First author
Last imported at : March 13, 2022, midnight Source : ClinicalTrials.gov |
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Contact
Last imported at : March 13, 2022, midnight Source : ClinicalTrials.gov |
fpeduard@einstein.br |
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Registration date
Last imported at : May 28, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
2021-05-26 |
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Recruitment status
Last imported at : March 13, 2022, midnight Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : May 28, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : May 28, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : March 13, 2022, midnight Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : May 28, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : May 28, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : May 28, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - positive for sars-cov-2 by the rt-pcr method, in common bed for minimum of 1 day and maximum of 5 days, ensuring that patients are no more than 10 days since showing the first symptoms, who are positive for sars-cov-2 in the first collection of oral fluid and saliva, and who demands oral hygiene care and other preventive and therapeutic dental procedures. |
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Exclusion criteria
Last imported at : May 31, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
- pediatric patients, t - hose who tested negative for sars-cov-2 by the rt-pcr method at the time of recruitment or at the time of first oral fluid and saliva collection; - those who exhibit oral ulcerations and other erosive lesions in the oral mucosa, which contraindicate the use of cetylpyridinium; - patients who have bleeding in the oral cavity which prevents sample collections; patients who report history of allergy, irritations or other side effects derived from the use of these substances; - patients who do not adhere to oral care protocols or those in whom it was not possible to perform these procedures. |
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Number of arms
Last imported at : May 28, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
3 |
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Funding
Last imported at : May 28, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Hospital Israelita Albert Einstein |
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Inclusion age min
Last imported at : May 28, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : May 28, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
90 |
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Countries
Last imported at : May 28, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Brazil |
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Type of patients
Last imported at : May 28, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Mild/moderate disease at enrollment |
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Severity scale
Last imported at : May 28, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
2: Mild/moderate disease at enrollment |
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Total sample size
Last imported at : May 28, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
105 |
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primary outcome
Last imported at : May 31, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Change of SARS-COV-2 load in the oral cavity and saliva |
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Notes
Last imported at : May 28, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
Not reported |
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Arms
Last imported at : May 28, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 268, "treatment_name": "Cetylpyridinium chloride", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2261, "treatment_name": "Cetylpyridinium chloride+zinc", "treatment_type": "Mouthwash+vitamins and dietary supplements", "pharmacological_treatment": "Non pharmacological treatment+pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |