Prospective, cross-sectional study evaluating the effect of commercially available mouthwashes on expelled/exhaled SARS-CoV-2 viral load using face mask sampling.
The study will consist of a Control Phase to optimize procedures for measuring expelled/exhaled viral load, and a Evaluation phase comparing different commercially available mouthwashes. In the Control Phase. up to 20 COVID-19 patients will be asked to undergo a sequence of face mask sampling and saliva collections prior to and after an oral rinse with (i) water and (ii) a commercially-available cetylpyridinium chloride (CPC) mouthwash. Based on outcomes of the Control Phase, the study will proceed into the Evaluation Phase, which will randomize approximately 40 COVID-19 patients to receive 1 of 4 commercially available Colgate mouthwashes following standard package instructions. Face mask sampling and saliva will be collected prior to and after the mouth rinse to assess impact on SARS-CoV-2 viral load.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
34
Commercially over-the-counter Colgate mouthwashes will be administered according to standard package instructions. Viral load will be measured prior to and after mouth rinse using serial face mask and saliva samples. Additionally viral load measured prior to and after water rinse using serial face mask and saliva samples. These serial measurements and both CPC and water rinses were conducted consecutively in one visit.
University Hospital
Newark, New Jersey, United States
Control Phase - Primary Endpoint
Reduction in viral load by face mask sampling from pre-intervention to 0-15 with CPC versus water rinse control
Time frame: Single timepoint, ~1 hour
Evaluation Phase - Primary Endpoint
Reduction in viral load by face mask sampling from pre-intervention to 45-60 minutes versus water rinse control
Time frame: Single timepoint, ~1.5 hours
Evaluation Phase - Secondary Endpoint
Reduction in viral load by face mask sampling from pre-intervention to 0-15 and15-30 minutes of oral rinse products versus water rinse control
Time frame: Single timepoint, ~1 hour
Comparative Saliva Reduction
Reduction in viral load in saliva pre-intervention to 30 and 60 minutes post-intervention.
Time frame: Single timepoint, ~1.5 hours
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