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

NCT ID: NCT04537962

Last Updated: 2022-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-14
• Study Completion Date: 2021-09-30

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.

Conditions

Corona Virus Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: PLACEBO_COMPARATOR

Colgate Periogard® mouthwash

Intervention Type: OTHER

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

Colgate Peroxyl® mouthwash

Intervention Type: OTHER

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

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;

Group Type: PLACEBO_COMPARATOR

Colgate Periogard® mouthwash

Intervention Type: OTHER

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

Colgate Peroxyl®

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

Group Type: PLACEBO_COMPARATOR

Colgate Peroxyl® mouthwash

Intervention Type: OTHER

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

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

Group Type: PLACEBO_COMPARATOR

Colgate Total® Mouthwash

Intervention Type: OTHER

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

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

Group Type: ACTIVE_COMPARATOR

Toothpaste with sodium monofluorophosphate

Intervention Type: OTHER

Patients will be submitted to brushing with toothpaste with sodium monofluorophosphate

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

Group Type: ACTIVE_COMPARATOR

Toothpaste with sodium fluoride and zinc

Intervention Type: OTHER

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

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

Group Type: ACTIVE_COMPARATOR

Toothpaste with tin fluoride

Intervention Type: OTHER

Patients will be submitted to brushing with toothpaste with tin fluoride

Interventions

Colgate Periogard® mouthwash

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

Intervention Type: OTHER

Colgate Peroxyl® mouthwash

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

Intervention Type: OTHER

Colgate Total® Mouthwash

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

Intervention Type: OTHER

Toothpaste with sodium monofluorophosphate

Patients will be submitted to brushing with toothpaste with sodium monofluorophosphate

Intervention Type: OTHER

Toothpaste with sodium fluoride and zinc

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

Intervention Type: OTHER

Toothpaste with tin fluoride

Patients will be submitted to brushing with toothpaste with tin fluoride

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Colgate Palmolive

INDUSTRY

Sponsor Role: collaborator

Hospital Israelita Albert Einstein

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luciana Correa, PhD

Role: STUDY_DIRECTOR

University of Sao Paulo

Debora H Douek, PhD

Role: STUDY_CHAIR

Hospital Israelita Albert Einstein

Locations

Hospital israelita Albert Einstein

São Paulo, , Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 35570015 (View on PubMed)

Other Identifiers

4172-20

Identifier Type: -

Identifier Source: org_study_id