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| Name | Class |
|---|---|
| Colgate Palmolive | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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; |
|
| Colgate Peroxyl® | Placebo Comparator | Patients hospitalized in negative pressure rooms - will undergo antisepsia of the oral mucosa with 1.5% hydrogen peroxide solution |
|
| 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 |
|
| Toothpaste with sodium monofluorophosphate | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colgate Periogard® mouthwash | Other | Patients will be submitted to antisepsia of the oral mucosa with Colgate Periogard® mouthwash |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luciana Correa, PhD | University of Sao Paulo | Study Director |
| Debora H Douek, PhD | Hospital Israelita Albert Einstein | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital israelita Albert Einstein | São Paulo | 05652-900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38130922 | Derived | 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. | |
| 35570015 |
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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
|
| 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 |
|
| 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 |
|
| Colgate Peroxyl® mouthwash | Other | Patients will be submitted to antisepsia of the oral mucosa with Colgate Peroxyl® mouthwash |
|
| Colgate Total® Mouthwash | Other | Patients will be submitted to antisepsia of the oral mucosa with Colgate Total® Mouthwash |
|
| Toothpaste with sodium monofluorophosphate | Other | Patients will be submitted to brushing with 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 tin fluoride | Other | Patients will be submitted to brushing with toothpaste with tin fluoride |
|
| 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. |
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D014100 | Toothpastes |
| C012980 | fluorophosphate |
| D012969 | Sodium Fluoride |
| D015032 | Zinc |
| D014002 | Tin Fluorides |
| ID | Term |
|---|---|
| D003802 | Dentifrices |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D002327 | Cariostatic Agents |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D028561 | Transition Elements |
| D008670 | Metals |
| D017971 | Tin Compounds |
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