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

Abstract

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, sore throat, nasal congestion, and chest pain) and APD group (cough, fatigue, shortness of breath, hyposmia/anosmia, dysgeusia, hoarse voice, sore throat, nasal congestion, chest pain, diarrhea, and irritability/confusion) during the follow-up period. There were statistically significant differences, with a higher prevalence of symptoms in the control group at T3 and T7. Dysgeusia, sore throat, and irritability/confusion were less prevalent in the APD group at T3, and shortness of breath, hyposmia/anosmia, dysgeusia, hoarse voice, sore throat, diarrhea, and irritability/confusion were more prevalent in the control group at T7.

Conclusions: Based on this methodology, the results demonstrated that the regular use of mouthwash and dentifrice-containing APD had a positive impact on the clinical symptoms, as reported by patients with COVID-19.

Keywords: Clinical symptoms; Covid-19; Dentifrices; Mouthwash.

Figure 1

CONSORT flow diagram.