Salivary SARS-CoV-2 Load of Covid-19 Patients After Oral Antimicrobial Solutions and Dentifrices

Study Overview
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Brief Summary
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The aim of this study is to analyze if the use of oral antimicrobial solutions and dentifricies are able to reduce the SARS-CoV-2 load in the saliva and oral mucosa. It will be allocated hospitalized patients positive for SARS-CoV-2 (confirmed by RT-PCR of nasopharynx swab tests) and with signs and symptoms of COVID-19. These patients will be divided into two groups: patients enrolled in negative pressure rooms (NPR), and patients enrolled in intensive care units (ICU) with orotracheal intubation. These two groups will receive interventions with oral antimicrobial solutions or dentifrices, containing different compounds. Saliva and oral mucosa swabs will be collected before the intervention, immediately after the intervention, and after 30min and 1h. The primary outcome is to verify if these products can reduce the SARS-CoV-2 load in the saliva and oral mucosa at these time periods, detected by the measurement of the viral load and the fold-reduction.

Detailed Description
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Each group of patients will receive specific interventions, as follows: NPR group (n=60) - three interventions with different mouthwashes solutions (12 patients in each intervention): 1) 0.12% chlorhexidine solution (Colgate Periogard®); 2) mouthwash with 1.5% hydrogen peroxide solution (Colgate Peroxyl®); 3) mouthwash with 0.075% cetylpyridinium chloride solution (Colgate Total 12®); 4) 1.5% hydrogen peroxide solution plus 0.12% chlorhexidine solution (Colgate Peroxyl® followed by Colgate Periogard®). The interventions will be compared with a Placebo, which will be a mouthwash with distilled water (n=12). NPR group (n=90) - three interventions with different dentifrices (30 patients in each intervention): 1) dentifrice containing only 1.1% fluoride, water, glycerin, cellulose, sodium lauryl sulfate, and sodium bicarbonate; 2) dentifrice containing 0.32% fluoride, 0.96% zinc, arginine, poloxamer, glycerin, water, hydrated silica, sodium lauryl sulfate, and sodium saccharin 3) dentifrice containing 0.454% stannous fluoride, water, sorbitol, hydrated silica, glycerin, tetrasodium pyrophosphate, microcrystalline cellulose, and xanthan gum . The interventions will be compared to each other. ICU group (n=52)- two interventions with different oral antimicrobial solutions (26 patients in each intervention): 1) 0.12% chlorhexidine solution (Colgate Periogard®); 2) 1.5% hydrogen peroxide solution plus 0.12% chlorhexidine solution (Colgate Peroxyl® followed by Colgate Periogard®). The interventions will be compared to each other.

Official Title
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Avaliação da Carga do vírus SARS-CoV-2 na Cavidade Oral e na Saliva após desinfecção Com soluções Antimicrobianas Orais e dentifrícios.

Conditions
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Corona Virus Infection

Intervention / Treatment
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* Other: Colgate Periogard® mouthwash
* Other: Colgate Peroxyl® mouthwash
* Other: Colgate Total® Mouthwash
* Other: Toothpaste with sodium monofluorophosphate
* Other: Toothpaste with sodium fluoride and zinc
* Other: Toothpaste with tin fluoride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients positive for SARS-CoV-2 using the RT-PCR method and requiring oral hygiene care and other preventive and therapeutic dental procedures. Exclusion Criteria: Pediatric patients, negative for SARS-CoV-2 by the RT-PCR method, exhibiting oral ulcerations and other erosive lesions in the oral mucosa that contraindicate the use of hydrogen peroxide, chlorhexidine and cetylpyridinium, patients who present bleeding in the oral cavity. that prevents the collection of samples, patients who report a history of allergy, irritations or other side effects derived from the use of these substances, who do not adhere to the oral care protocols or those in which it is not possible to perform these procedures.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Colgate Periogard and Peroxyl®<br>Patients hospitalized in the ICU with orotracheal intubation or negative pressure room - will undergo antisepsia of the oral mucosa with 1.5% hydrogen peroxide solution, following by a 0.12% non-alcoholic chlorhexidine solution | Other: Colgate Periogard® mouthwash<br>* Patients will be submitted to antisepsia of the oral mucosa with Colgate Periogard® mouthwash<br>Other: Colgate Peroxyl® mouthwash<br>* Patients will be submitted to antisepsia of the oral mucosa with Colgate Peroxyl® mouthwash<br>|
| Placebo Comparator: Colgate Periogard®<br>Patients hospitalized in the ICU with orotracheal intubation or negative pressure room - will undergo antisepsia of the oral mucosa with 0.12% non-alcoholic chlorhexidine solution; | Other: Colgate Periogard® mouthwash<br>* Patients will be submitted to antisepsia of the oral mucosa with Colgate Periogard® mouthwash<br>|
| Placebo Comparator: Colgate Peroxyl®<br>Patients hospitalized in negative pressure rooms - will undergo antisepsia of the oral mucosa with 1.5% hydrogen peroxide solution | Other: Colgate Peroxyl® mouthwash<br>* Patients will be submitted to antisepsia of the oral mucosa with Colgate Peroxyl® mouthwash<br>|
| Placebo Comparator: Colgate Total 12®<br>Patients hospitalized in negative pressure rooms - will undergo antisepsia of the oral mucosa with 0.075% cetylpyridinium chloride associated with 0.28% zinc lactate | Other: Colgate Total® Mouthwash<br>* Patients will be submitted to antisepsia of the oral mucosa with Colgate Total® Mouthwash<br>|
| Active Comparator: Toothpaste with sodium monofluorophosphate<br>Patients hospitalized in negative pressure rooms - will undergo brushing with dentifrice containing only 1.1% fluoride, water, glycerin, cellulose, sodium lauryl sulfate, and sodium bicarbonate | Other: Toothpaste with sodium monofluorophosphate<br>* Patients will be submitted to brushing with toothpaste with sodium monofluorophosphate<br>|
| Active Comparator: Toothpaste with sodium fluoride and zinc<br>Patients hospitalized in negative pressure rooms - will undergo brushing with dentifrice containing 0.32% fluoride, 0.96% zinc, arginine, poloxamer, glycerin, water, hydrated silica, sodium lauryl sulfate, and sodium saccharin | Other: Toothpaste with sodium fluoride and zinc<br>* Patients will be submitted to brushing with toothpaste with sodium fluoride and zinc<br>|
| Active Comparator: Toothpaste with tin fluoride<br>Patients hospitalized in negative pressure rooms - will undergo brushing with dentifrice containing 0.454% stannous fluoride, water, sorbitol, hydrated silica, glycerin, tetrasodium pyrophosphate, microcrystalline cellulose, and xanthan gum | Other: Toothpaste with tin fluoride<br>* Patients will be submitted to brushing with toothpaste with tin fluoride<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of SARS-CoV-2 load in the oral mucosa and saliva | Reduction of SARS-CoV-2 load in the oral mucosa and saliva measured by viral fold-reduction and viral quantitation | 1 hour |