NCT04537962

Salivary SARS-CoV-2 Load of Covid-19 Patients After Oral Antimicrobial Solutions and Dentifrices

Completed NA Last updated 25 February 2022

What this trial tests

NA trial testing Colgate Periogard® mouthwash in Corona Virus Infection in 202 participants. Completed in 30 September 2021.

Timeline

14 July 2020

Primary endpoint
30 December 2020

30 September 2021

Quick facts

Lead sponsor	Hospital Israelita Albert Einstein
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	triple
Primary purpose	supportive care
Enrollment	202
Start date	14 July 2020
Primary completion	30 December 2020
Estimated completion	30 September 2021
Sites	1 location across Brazil

Drugs / interventions tested

• Colgate Periogard® mouthwash
• Colgate Peroxyl® mouthwash
• Colgate Total® Mouthwash
• Toothpaste with sodium monofluorophosphate
• Toothpaste with sodium fluoride and zinc
• Toothpaste with tin fluoride

Conditions studied

• Corona Virus Infection — all drugs for Corona Virus Infection →

Sponsor

Hospital Israelita Albert Einstein

Who can join

Adults 18 to 90, any sex, with Corona Virus Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Salivary SARS-CoV-2 load reduction with mouthwash use: A randomized pilot clinical trial.
   Eduardo FP, Corrêa L, Heller D, Daep CA, et al · · 2021 · cited 63× · PMID 34189331 · DOI 10.1016/j.heliyon.2021.e07346
2. Review of the use of nasal and oral antiseptics during a global pandemic.
   Stathis C, Victoria N, Loomis K, Nguyen SA, et al · · 2021 · cited 21× · PMID 33464122 · DOI 10.2217/fmb-2020-0286
3. Effectiveness of Toothpastes on SARS-CoV-2 Viral Load in Saliva.
   Eduardo FP, Corrêa L, Mansur F, Benitez C, et al · · 2022 · cited 6× · PMID 35570015 · DOI 10.1016/j.identj.2022.03.006
4. Antimicrobial oral lavage reduces the SARS-CoV-2 load in intubated patients: randomized clinical trial.
   Bezinelli LM, Corrêa L, Beyerstedt S, Rangel ÉB, et al · · 2023 · cited 3× · PMID 37152554 · DOI 10.1080/20002297.2022.2152179
5. Reduction of SARS-CoV-2 viral load in saliva after rinsing with mouthwashes containing cetylpyridinium chloride: a randomized clinical study.
   Bezinelli LM, Corrêa L, Beyerstedt S, Franco ML, et al · · 2023 · cited 2× · PMID 38130922 · DOI 10.7717/peerj.15080