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

Primary Purpose

Corona Virus Infection

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Colgate Periogard® mouthwash
Colgate Peroxyl® mouthwash
Colgate Total® Mouthwash
Toothpaste with sodium monofluorophosphate
Toothpaste with sodium fluoride and zinc
Toothpaste with tin fluoride
Sponsored by
Hospital Israelita Albert Einstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Corona Virus Infection

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital israelita Albert Einstein

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Placebo Comparator

Placebo Comparator

Placebo Comparator

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Colgate Periogard and Peroxyl®

Colgate Periogard®

Colgate Peroxyl®

Colgate Total 12®

Toothpaste with sodium monofluorophosphate

Toothpaste with sodium fluoride and zinc

Toothpaste with tin fluoride

Arm Description

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

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;

Patients hospitalized in negative pressure rooms - will undergo antisepsia of the oral mucosa with 1.5% hydrogen peroxide solution

Patients hospitalized in negative pressure rooms - will undergo antisepsia of the oral mucosa with 0.075% cetylpyridinium chloride associated with 0.28% zinc lactate

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 14, 2020
Last Updated
February 24, 2022
Sponsor
Hospital Israelita Albert Einstein
Collaborators
Colgate Palmolive
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1. Study Identification

Unique Protocol Identification Number
NCT04537962
Brief Title
Salivary SARS-CoV-2 Load of Covid-19 Patients After Oral Antimicrobial Solutions and Dentifrices
Official Title
Avaliação da Carga do vírus SARS-CoV-2 na Cavidade Oral e na Saliva após desinfecção Com soluções Antimicrobianas Orais e dentifrícios.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 14, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Israelita Albert Einstein
Collaborators
Colgate Palmolive

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corona Virus Infection

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Colgate Periogard and Peroxyl®
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Colgate Periogard®
Arm Type
Placebo Comparator
Arm Description
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;
Arm Title
Colgate Peroxyl®
Arm Type
Placebo Comparator
Arm Description
Patients hospitalized in negative pressure rooms - will undergo antisepsia of the oral mucosa with 1.5% hydrogen peroxide solution
Arm Title
Colgate Total 12®
Arm Type
Placebo Comparator
Arm Description
Patients hospitalized in negative pressure rooms - will undergo antisepsia of the oral mucosa with 0.075% cetylpyridinium chloride associated with 0.28% zinc lactate
Arm Title
Toothpaste with sodium monofluorophosphate
Arm Type
Active Comparator
Arm Description
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
Arm Title
Toothpaste with sodium fluoride and zinc
Arm Type
Active Comparator
Arm Description
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
Arm Title
Toothpaste with tin fluoride
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Colgate Periogard® mouthwash
Intervention Description
Patients will be submitted to antisepsia of the oral mucosa with Colgate Periogard® mouthwash
Intervention Type
Other
Intervention Name(s)
Colgate Peroxyl® mouthwash
Intervention Description
Patients will be submitted to antisepsia of the oral mucosa with Colgate Peroxyl® mouthwash
Intervention Type
Other
Intervention Name(s)
Colgate Total® Mouthwash
Intervention Description
Patients will be submitted to antisepsia of the oral mucosa with Colgate Total® Mouthwash
Intervention Type
Other
Intervention Name(s)
Toothpaste with sodium monofluorophosphate
Intervention Description
Patients will be submitted to brushing with toothpaste with sodium monofluorophosphate
Intervention Type
Other
Intervention Name(s)
Toothpaste with sodium fluoride and zinc
Intervention Description
Patients will be submitted to brushing with toothpaste with sodium fluoride and zinc
Intervention Type
Other
Intervention Name(s)
Toothpaste with tin fluoride
Intervention Description
Patients will be submitted to brushing with toothpaste with tin fluoride
Primary Outcome Measure Information:
Title
Reduction of SARS-CoV-2 load in the oral mucosa and saliva
Description
Reduction of SARS-CoV-2 load in the oral mucosa and saliva measured by viral fold-reduction and viral quantitation
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luciana Correa, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Debora H Douek, PhD
Organizational Affiliation
Hospital Israelita Albert Einstein
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital israelita Albert Einstein
City
Sao Paulo
ZIP/Postal Code
05652-900
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
35570015
Citation
Eduardo FP, Correa L, Mansur F, Benitez C, Hamerschlak N, Pinho JRR, Heller D, Bezinelli LM. Effectiveness of Toothpastes on SARS-CoV-2 Viral Load in Saliva. Int Dent J. 2022 Dec;72(6):825-831. doi: 10.1016/j.identj.2022.03.006. Epub 2022 Mar 23.
Results Reference
derived

Learn more about this trial

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

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