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Use of mouthwash and dentifrice containing antimicrobial phthalocyanine derivative for the reduction of clinical symptoms of COVID-19: A randomized triple-blinded clinical trial

Poleti et al., Journal of Evidence-Based Dental Practice, doi:10.1016/j.jebdp.2022.101777 (date from preprint), RBR-8x8g36

Dec 2021

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Phthalocyanine

29th treatment shown to reduce risk in December 2021

^*, now known with p = 0.00019 from 4 studies.

Lower risk for ICU admission, hospitalization, recovery, and viral clearance.

No treatment is 100% effective. Protocols combine complementary and synergistic treatments. ^* >10% efficacy in meta analysis with ≥3 clinical studies.

4,100+ studies for 60+ treatments. c19early.org

RCT 500 patients in Brazil, showing improved recovery with a phthalocyanine derivative mouthwash and toothpaste. Toothbrushing for 2 minutes, three times per day, and gargling/rising (5ml) for one minute, three times a day, for 7 days.

3 studies use direct respiratory tract administration Brito-Reia, da Silva Santos, Poleti

Targeted administration to the respiratory tract provides treatment directly to the typical source of initial SARS-CoV-2 infection and replication, and allows for rapid onset of action, higher local drug concentration, and reduced systemic side effects.

Important missing comments or errors? Let us know.

risk of no recovery, 29.1% lower, RR 0.71, p = 0.02, treatment 29 of 59 (49.2%), control 52 of 75 (69.3%), NNT 5.0, day 7.

risk of no recovery, 22.1% lower, RR 0.78, p = 0.02, treatment 38 of 59 (64.4%), control 62 of 75 (82.7%), NNT 5.5, day 3.

risk of no recovery, 45.5% lower, RR 0.54, p = 0.04, treatment 12 of 59 (20.3%), control 28 of 75 (37.3%), NNT 5.9, day 7, dyspnea.

risk of no recovery, 32.5% lower, RR 0.68, p = 0.11, treatment 17 of 59 (28.8%), control 32 of 75 (42.7%), NNT 7.2, day 3, dyspnea.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

1. Brito-Reia et al., Population-based virucidal phthalocyanine gargling/rinsing protocol to reduce the risk of coronavirus disease-2019: a community trial, German Medical Science GMS Publishing House, doi:10.3205/dgkh000426.egms.de, doi.org.

2. da Silva Santos et al., Beneficial effects of a mouthwash containing an antiviral phthalocyanine derivative on the length of hospital stay for COVID-19: randomised trial, Scientific Reports, doi:10.1038/s41598-021-99013-5.nature.com, doi.org.

3. Poleti et al., Use of mouthwash and dentifrice containing antimicrobial phthalocyanine derivative for the reduction of clinical symptoms of COVID-19: A randomized triple-blinded clinical trial, Journal of Evidence-Based Dental Practice, doi:10.1016/j.jebdp.2022.101777.sciencedirect.com, doi.org.

Poleti et al., 8 Dec 2021, Double Blind Randomized Controlled Trial, Brazil, peer-reviewed, 10 authors, study period 6 November, 2020 - 19 November, 2020, trial RBR-8x8g36. Contact: marcelo_poleti@yahoo.com.br.

This Paper Phthalocyanine All

AI generated summary. Current AI models can provide useful summaries for non-experts, but may be inaccurate and have limited ability to analyze larger context such as the entire evidence base for phthalocyanine.

A mouthwash and dentifrice containing an antimicrobial phthalocyanine derivative (APD) may be an effective way to reduce the severity of clinical symptoms in patients with COVID-19.

This scientific article studies the use of a mouthwash and dentifrice containing an antimicrobial phthalocyanine derivative (APD) to reduce the clinical symptoms of COVID-19. The study was conducted on 134 patients who were randomly assigned to either the APD group or the control group. The APD group used the mouthwash and dentifrice containing APD, while the control group used a regular mouthwash and dentifrice. The patients were followed for 7 days, and their clinical symptoms were assessed at baseline (T0), 3 days (T3), and 7 days (T7).

The results of the study showed that there was a statistically significant reduction in clinical symptoms in the APD group at T3 and T7. The most common symptoms that were reduced in the APD group were cough, fatigue, shortness of breath, hoarse voice, sore throat, nasal congestion, chest pain, diarrhea, and irritability/confusion.

The authors of the study concluded that the use of a mouthwash and dentifrice containing APD may be an effective way to reduce the clinical symptoms of COVID-19. However, more research is needed to confirm these findings.

Here are some additional details from the study:

The APD mouthwash and dentifrice were used twice a day for 7 days.
The patients in the control group used a regular mouthwash and dentifrice twice a day for 7 days.
The patients were not aware of which group they were assigned to.
The investigators who assessed the patients' symptoms were also not aware of which group the patients were assigned to.

The study was funded by the Brazilian Ministry of Health.

USE OF MOUTHWASH AND DENTIFRICE CONTAINING AN ANTIMICROBIAL PHTHALOCYANINE DERIVATIVE FOR THE REDUCTION OF CLINICAL SYMPTOMS OF COVID-19: A RANDOMIZED TRIPLE-BLIND CLINICAL TRIAL

Marcelo Lupion Poleti, Danielle Gregório, Alisson Gabriel Idelfonso Bistaffa, Karen Barros Parron Fernandes, Fabiano Vieira Vilhena, Paulo Sérgio Da Silva Santos, Andréa Name Colado Simão, Marcell Alysson Batisti Lozovoy, Berenice Tomoko Tatibana, Thais Maria Freire Fernandes

Journal of Evidence-Based Dental Practice, doi:10.1016/j.jebdp.2022.101777

Purpose This clinical trial aimed to evaluate the use of mouthwash and dentifrice containing an antimicrobial phthalocyanine derivative (APD) to reduce the clinical symptoms in patients with COVID-19. Methods This randomized, triple-blind clinical trial enrolled 134 patients aged 18 years or older who underwent COVID-19 testing through the use of nasopharyngeal swab RT-qPCR in a reference center for the diagnosis of COVID-19, had no clinical contraindications to mouthwash and gargle, and had access to cell phones with communication applications. According to the use of a mouthwash and dentifrice containing antimicrobial phthalocyanine derivatives (APD), patients were randomly assigned (1:1) to the APD or non-APD (control) group. All participants were instructed to floss twice a day, brush teeth for 2 minutes 3 times a day, and gargle/rinse (5 mL) for 1 min/3 times a day for 7 days. An online questionnaire was sent to collect data on the clinical symptoms of COVID-19 3 times: T0 (baseline before using the oral hygiene products), T3 (3 days after), and T7 (7 days after). The investigators, patients, and outcome assessors were blinded to group assignment. The Mann-Whitney, Chi -Square, Fisher's exact, and Cochran's tests were used according to the nature of the variables studied, with the level of significance set at P < .05. Results No statistically significant difference was found in the prevalence of symptoms between groups at baseline. A statistically significant reduction in clinical symptoms was found in the control group (fatigue, shortness of breath, hoarse voice,

ACKNOWLEDGMENT The authors gratefully acknowledge the Londrina Municipal Health Authority for their support in this study. CREDIT AUTHOR STATEMENT

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