Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04537962 |
| Other study ID # |
4172-20 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 14, 2020 |
| Est. completion date |
September 30, 2021 |
Study information
| Verified date |
July 2020 |
| Source |
Hospital Israelita Albert Einstein |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
