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

Sponsor

Hospital Israelita Albert Einstein (Other)

Overall Status

Completed

CT.gov ID

NCT04537962

Collaborator

Colgate Palmolive (Industry)

202

Enrollment

Location

Arms

14.6

Actual Duration (Months)

13.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Corona Virus Infection	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	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

202 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jul 14, 2020

Actual Primary Completion Date :

Dec 30, 2020

Actual Study Completion Date :

Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Colgate Periogard and Peroxyl® 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 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
Placebo Comparator: Colgate Periogard® 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 Patients will be submitted to antisepsia of the oral mucosa with Colgate Periogard® mouthwash
Placebo Comparator: Colgate Peroxyl® Patients hospitalized in negative pressure rooms - will undergo antisepsia of the oral mucosa with 1.5% hydrogen peroxide solution	Other: Colgate Peroxyl® mouthwash Patients will be submitted to antisepsia of the oral mucosa with Colgate Peroxyl® mouthwash
Placebo Comparator: Colgate Total 12® 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 Patients will be submitted to antisepsia of the oral mucosa with Colgate Total® Mouthwash
Active Comparator: Toothpaste with sodium monofluorophosphate 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 Patients will be submitted to brushing with toothpaste with sodium monofluorophosphate
Active Comparator: Toothpaste with sodium fluoride and zinc 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 Patients will be submitted to brushing with toothpaste with sodium fluoride and zinc
Active Comparator: Toothpaste with tin fluoride 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 Patients will be submitted to brushing with toothpaste with tin fluoride

Outcome Measures

Primary Outcome Measures

Reduction of SARS-CoV-2 load in the oral mucosa and saliva [1 hour]
Reduction of SARS-CoV-2 load in the oral mucosa and saliva measured by viral fold-reduction and viral quantitation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.