Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04537962
Status:
COMPLETED
Last Update Posted:
2022-02-25
First Post:
2020-07-14
Brief Title:
Salivary SARS-CoV-2 Load of Covid-19 Patients After Oral Antimicrobial Solutions and Dentifrices
Sponsor:
Hospital Israelita Albert Einstein
Organization:
Hospital Israelita Albert Einstein
Study Overview
Official Title:
Avaliação da Carga do vírus SARS-CoV-2 na Cavidade Oral e na Saliva após desinfecção Com soluções Antimicrobianas Orais e dentifrícios
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n60 - three interventions with different mouthwashes solutions 12 patients in each intervention 1 012 chlorhexidine solution Colgate Periogard 2 mouthwash with 15 hydrogen peroxide solution Colgate Peroxyl 3 mouthwash with 0075 cetylpyridinium chloride solution Colgate Total 12 4 15 hydrogen peroxide solution plus 012 chlorhexidine solution Colgate Peroxyl followed by Colgate Periogard
The interventions will be compared with a Placebo which will be a mouthwash with distilled water n12
NPR group n90 - three interventions with different dentifrices 30 patients in each intervention 1 dentifrice containing only 11 fluoride water glycerin cellulose sodium lauryl sulfate and sodium bicarbonate 2 dentifrice containing 032 fluoride 096 zinc arginine poloxamer glycerin water hydrated silica sodium lauryl sulfate and sodium saccharin 3 dentifrice containing 0454 stannous fluoride water sorbitol hydrated silica glycerin tetrasodium pyrophosphate microcrystalline cellulose and xanthan gum
The interventions will be compared to each other ICU group n52- two interventions with different oral antimicrobial solutions 26 patients in each intervention 1 012 chlorhexidine solution Colgate Periogard 2 15 hydrogen peroxide solution plus 012 chlorhexidine solution Colgate Peroxyl followed by Colgate Periogard
The interventions will be compared to each other
NPR group n60 - three interventions with different mouthwashes solutions 12 patients in each intervention 1 012 chlorhexidine solution Colgate Periogard 2 mouthwash with 15 hydrogen peroxide solution Colgate Peroxyl 3 mouthwash with 0075 cetylpyridinium chloride solution Colgate Total 12 4 15 hydrogen peroxide solution plus 012 chlorhexidine solution Colgate Peroxyl followed by Colgate Periogard
The interventions will be compared with a Placebo which will be a mouthwash with distilled water n12
NPR group n90 - three interventions with different dentifrices 30 patients in each intervention 1 dentifrice containing only 11 fluoride water glycerin cellulose sodium lauryl sulfate and sodium bicarbonate 2 dentifrice containing 032 fluoride 096 zinc arginine poloxamer glycerin water hydrated silica sodium lauryl sulfate and sodium saccharin 3 dentifrice containing 0454 stannous fluoride water sorbitol hydrated silica glycerin tetrasodium pyrophosphate microcrystalline cellulose and xanthan gum
The interventions will be compared to each other ICU group n52- two interventions with different oral antimicrobial solutions 26 patients in each intervention 1 012 chlorhexidine solution Colgate Periogard 2 15 hydrogen peroxide solution plus 012 chlorhexidine solution Colgate Peroxyl followed by Colgate Periogard
The interventions will be compared to each other
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None