- The product was approved by Anvisa, Brazil’s health regulator, in October and should reach consumers in December;
- The studies have been peer-reviewed and are being submitted to international scientific journals;
- Researchers say that the product must be seen as an adjunct to the virus prevention measures, not medicine.
A mouthwash capable of inactivating 96% of SARS-Cov-2 in the mouth, blocking the virus’s proliferation in the oral cavity and preventing it from spreading through the body. That’s what a series of studies released on Tuesday and made by scientists and the manufacturer of personal care products DentalClean show. The studies have been peer-reviewed.
The product was already approved by Anvisa, Brazil’s health regulator, in October and should start reaching consumers in December. The research, which took nine months between laboratory tests and clinical trials, 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).
With that, the mouthwash and oral antiseptic proved to be a new way of preventing COVID-19 from spreading. According to the researchers, the patients become asymptomatic a few days after starting the antiseptic use protocol: five daily rinses of one minute each.
“PHTALOX is a compound developed that allows the formation of reactive oxygen from molecular oxygen, that is, it transforms oxygen from the oral cavity into reactive oxygen and this molecule is capable of inactivating SARS-Cov-2”, explained the researcher Fabiano Vilhena, during a press conference.
Vilhena, who is also a Sanitary Dentist and Doctor of Oral Biology at USP (the State University of Sao Paulo), 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. It is where the virus develops itself and then spreads to the body, following the path of the trachea and going down to the bronchi and causing inflammatory reactions. By preventing the virus from multiplying and advancing, the patient becomes asymptomatic.
The work has been underway for months by scientists from the Faculty of Dentistry of USP Bauru, the Institute of Biological Sciences at USP, the State University of Londrina, and the Federal Institute of Paraná, together with the Research and Innovation Center of the company Dentalclean, developer of the product.
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 worlwide.
Some patients who used the placebo died
The triple-blind randomized clinical study that involved the Research Center of the Faculty of Dentistry of Bauru (USP) and the State Hospital of the city, with 18 researchers started in August; 91 volunteer patients were selected to participate in the research among those admitted to the State Hospital of Bauru with symptoms of COVID-19.
According to the study, 50 of them had negative RT-PCR results, despite being hospitalized with symptoms; then, they were excluded from the research because they were negative for the disease. The 41 patients hospitalized with positive RT-PCR and a mild to moderate degree of the disease were divided into two groups: those who used active oral antiseptic with PHTALOX® and those who used a placebo (water + flavor + dye).
On average, the patients of the active group was older than the placebo group. Both groups used the same drugs to treat COVID-19, differing only about the mouthwash product. According to the study, the scientific literature shows a tendency for younger patients to be discharged faster than older ones, so the placebo group was expected to recover faster. However, the youngest patients in the sample stayed almost twice as long in the hospital as individuals who used PHTALOX®.
Another result that surprised the researchers is related to the severity of the disease. Among the individuals who used the placebo, 1/3 required admission to the intensive care unit (ICU) due to severe conditions, and half of them died. In the group that used real mouthwash, no patient needed to be referred to the ICU and none of them died.
The studies are being submitted to international scientific journals. Another ten studies of the same research with new institutions, including epidemiological, clinical, and case-control studies will involve about 2,100 people. The surveys will be finalized and also submitted for publication expected for the beginning of 2021. All researches were approved by the Research Ethics Committee in Human Beings of the Ministry of Health and registered with ReBEC, the Brazilian Registry of Clinical Trials.
Dentalclean invested more than BRL 10 million in this research, including product development, expansion of the factory, and equipment acquisition. The DETOX PRO antiseptic, which is the commercial name of the mouthwash containing PHTALOX®, is expected to reach pharmacies and supermarkets in December with a suggested price of BRL 30.