- The cancellation reasons were forwarded to Dentalclean by letter, and the decision is still subject to appeal.
- The product’s manufacturer, Dentalclean, said that it would appeal and ask for new registration.
Brazil’s National Health Surveillance Agency (Anvisa) canceled the registration of a mouthwash that promises to inactivate in 96% the proliferation of the virus that causes COVID-19.
The product, called Dental Pro and developed by the Dentalclean Research and Innovation Center and supported by researchers from four public universities (Faculty of Dentistry of USP Bauru, the Institute of Biological Sciences at USP, the State University of Londrina, and the Federal Institute of Paraná), was approved by the regulator and available for sale since December last year.
The agency told G1 that the registration was canceled on Monday (11) for irregularities in the notification process. The cancellation reasons were forwarded to Dentalclean by letter, and the decision is still subject to appeal. “At a time when several new technologies have presented themselves as possible barriers to the proliferation of SARS-CoV-2, about products under Health Surveillance, Law No. 6,360, of September 23, 1976, is very clear concerning the need for proof of efficacy and safety, and in the case in question, this proof of additional efficacy did not occur in the documentation submitted so far, “Anvisa told G1.
To LABS, Dentalclean said it “is working to clarify all issues with Anvisa and make the product available to consumers again”. To consumers who are already using the product, the company pointed out that “the product does not present any contraindications.”
In an interview with LABS last November, Fabiano Vilhena, a Sanitary Dentist and Doctor of Oral Biology at USP (the State University of Sao Paulo) that participated in the research, said that the study that leads to the launch of the product took nine months between laboratory tests and clinical trials and involved 107 people in a randomized, triple-blind clinical study (when neither the patient nor the researcher knows who used the placebo and who used the real substance).
READ ALSO: Analysis: Not company earnings, not data but vaccines now steering investor sentiment
Vilhena explained that “the virus has a clear path inside the body. “The entry route is via the upper airway, eyes, nose, and mouth. The virus has to stay in someplace to multiply, which are mainly salivary glands, amygdala, and tongue. The virus develops itself and then spreads to the body, following the trachea’s path and going down to the bronchi and causing inflammatory reactions. By preventing the virus from multiplying and advancing, the patient becomes asymptomatic. The compound that gives the mouthwash the ability to stop the coronavirus inside the body has been called PHTALOX.
READ ALSO: Brazilian pharmaceutical defends Sputnik V emergency use approval before phase 3 trials
Studying the effects of mouthwash and oral antiseptic rinses on infectious viruses is not a novelty, but it has gained more attention since the coronavirus outbreak started. Several other studies similar to this one were published worldwide.
