Salivary SARS-CoV-2 Load of Covid-19 Patients After Oral Antimicrobial Solutions and Dentifrices
Condition: Corona Virus Infection
MeSH terms: Coronavirus Infections
Study type: Interventional

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.
    

Intervention name(s): Colgate Periogard® mouthwash; Colgate Peroxyl® mouthwash; Colgate Total® Mouthwash; Toothpaste with sodium monofluorophosphate; Toothpaste with sodium fluoride and zinc; Toothpaste with tin fluoride
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Patients will be submitted to antisepsia of the oral mucosa with Colgate Periogard® mouthwash; Patients will be submitted to antisepsia of the oral mucosa with Colgate Peroxyl® mouthwash; Patients will be submitted to antisepsia of the oral mucosa with Colgate Total® Mouthwash; Patients will be submitted to brushing with toothpaste with sodium monofluorophosphate; Patients will be submitted to brushing with toothpaste with sodium fluoride and zinc; Patients will be submitted to brushing with toothpaste with tin fluoride
Intervention MeSH terms: Listerine; Cetylpyridinium; Fluorides; Sodium Fluoride; Fluorophosphate; Tin Fluorides
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care