NCT04537962

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Hospital Israelita Albert Einstein · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Corona Virus Infection

Interventions

Type	Name	Description
OTHER	Colgate Periogard® mouthwash	Patients will be submitted to antisepsia of the oral mucosa with Colgate Periogard® mouthwash
OTHER	Colgate Peroxyl® mouthwash	Patients will be submitted to antisepsia of the oral mucosa with Colgate Peroxyl® mouthwash
OTHER	Colgate Total® Mouthwash	Patients will be submitted to antisepsia of the oral mucosa with Colgate Total® Mouthwash
OTHER	Toothpaste with sodium monofluorophosphate	Patients will be submitted to brushing with toothpaste with sodium monofluorophosphate
OTHER	Toothpaste with sodium fluoride and zinc	Patients will be submitted to brushing with toothpaste with sodium fluoride and zinc
OTHER	Toothpaste with tin fluoride	Patients will be submitted to brushing with toothpaste with tin fluoride

Timeline

• Start date: 2020-07-14
• Primary completion: 2020-12-30
• Completion: 2021-09-30
• First posted: 2020-09-03
• Last updated: 2022-02-25

Locations

1 site across 1 country: Brazil