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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04537962
Enrollment
202
Registered
2020-09-03
Start date
2020-07-14
Completion date
2021-09-30
Last updated
2022-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corona Virus Infection

Brief 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.

Interventions

OTHERColgate Periogard® mouthwash

Patients will be submitted to antisepsia of the oral mucosa with Colgate Periogard® mouthwash

OTHERColgate Peroxyl® mouthwash

Patients will be submitted to antisepsia of the oral mucosa with Colgate Peroxyl® mouthwash

OTHERColgate Total® Mouthwash

Patients will be submitted to antisepsia of the oral mucosa with Colgate Total® Mouthwash

Patients will be submitted to brushing with toothpaste with sodium monofluorophosphate

OTHERToothpaste with sodium fluoride and zinc

Patients will be submitted to brushing with toothpaste with sodium fluoride and zinc

OTHERToothpaste with tin fluoride

Patients will be submitted to brushing with toothpaste with tin fluoride

Sponsors

Colgate Palmolive
CollaboratorINDUSTRY
Hospital Israelita Albert Einstein
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Reduction of SARS-CoV-2 load in the oral mucosa and saliva1 hourReduction of SARS-CoV-2 load in the oral mucosa and saliva measured by viral fold-reduction and viral quantitation

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026