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

NCT04537962 | Completed DMC

• 1 other identifier: 4172-20
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Corona Virus Infection

Outcome Measures

Primary Outcomes (1)

• 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

  1 hour

Study Arms (7)

Colgate Periogard and Peroxyl®

PLACEBO COMPARATOR

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; Other: Colgate Peroxyl® mouthwash

Colgate Periogard®

PLACEBO COMPARATOR

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

Colgate Peroxyl®

PLACEBO COMPARATOR

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

Other: Colgate Peroxyl® mouthwash

Colgate Total 12®

PLACEBO COMPARATOR

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

Toothpaste with sodium monofluorophosphate

ACTIVE COMPARATOR

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

Toothpaste with sodium fluoride and zinc

ACTIVE COMPARATOR

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

Toothpaste with tin fluoride

ACTIVE COMPARATOR

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

Interventions

Colgate Periogard® mouthwash OTHER

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

Colgate Periogard and Peroxyl®; Colgate Periogard®

Colgate Peroxyl® mouthwash OTHER

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

Colgate Periogard and Peroxyl®; Colgate Peroxyl®

Colgate Total® Mouthwash OTHER

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

Colgate Total 12®

Toothpaste with sodium monofluorophosphate OTHER

Patients will be submitted to brushing with toothpaste with sodium monofluorophosphate

Toothpaste with sodium monofluorophosphate

Toothpaste with sodium fluoride and zinc OTHER

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

Toothpaste with sodium fluoride and zinc

Toothpaste with tin fluoride OTHER

Patients will be submitted to brushing with toothpaste with tin fluoride

Toothpaste with tin fluoride

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients positive for SARS-CoV-2 using the RT-PCR method and requiring oral hygiene care and other preventive and therapeutic dental procedures.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• Colgate Palmolive: collaborator

Study Sites (1)

Hospital israelita Albert Einstein

São Paulo, 05652-900, Brazil

Location

Related Publications (2)

• Bezinelli LM, Correa L, Beyerstedt S, Franco ML, Rangel EB, Benitez CG, Hamerschlak N, Pinho JRR, Heller D, Eduardo FP. Reduction of SARS-CoV-2 viral load in saliva after rinsing with mouthwashes containing cetylpyridinium chloride: a randomized clinical study. PeerJ. 2023 Dec 18;11:e15080. doi: 10.7717/peerj.15080. eCollection 2023.

  PMID: 38130922 DERIVED

• 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.

  PMID: 35570015 DERIVED

MeSH Terms

Conditions

Coronavirus Infections

Interventions

Toothpastes; fluorophosphate; Sodium Fluoride; Zinc; Tin Fluorides

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Dentifrices; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Metals, Heavy; Elements; Transition Elements; Metals; Tin Compounds

Study Officials

• Luciana Correa, PhD

  University of Sao Paulo

  STUDY DIRECTOR

• Debora H Douek, PhD

  Hospital Israelita Albert Einstein

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: September 3, 2020
• Study Start: July 14, 2020
• Primary Completion: December 30, 2020
• Study Completion: September 30, 2021
• Last Updated: February 25, 2022

Record last verified: 2020-07

Locations

BR (1)