Avaliação de tolerância e segurança de espuma contendo óleos essenciais com potencial para prevenção e tratamento da mucosite oral - estudo de fase I

Abstract

Oral mucositis (OM) is an inflammatory process resulting from the cytotoxic adverse effect of treatment of radiotherapy and chemotherapy in patients with cancer and has as clinical manifestation painful ulcerations. The essential oils (EOs) have been studied among the bioactive agents with promising antimicrobial activity; among them we have the Lippia sidoides Cham., which has been used in the treatment of several pathologies due to its anti-inflammatory, antioxidant, antifungal and antibacterial action. This work aims to evaluate the organoleptic characteristics, antimicrobial activity and cytotoxicity of a foam containing essential oil of Lippia sidoides Cham. for prevention and treatment of oral mucositis in healthy patients. It was a randomized, interventional clinical trial involving 50 healthy individuals who underwent the use of the test product based on Lippia sidoides Cham. at 0.5% (G1), 0.5% associated with EO of Cymbopogon citratus 0.3% + Citrus limon 0.1% (G2), 0.25% associated with EOs of Cymbopogon citratus 0.2% + Citrus limon 0.2% (G3), placebo with excipients without essential oils (G4) and placebo with excipients + essential oil of Cymbopogon citratus + Citrus limon (G5). The saliva was collected before and after the use of the products, diluted to 10-1,10-3 and 10-5 and plated in the culture media: BHI Agar, Sabouraud Agar, Mitis Salivarius Agar and Manitol Salt Agar and counting the colonies expressed in CFU/mL. Papanicolau staining and Periodic acid-Schiff staining (PAS) were also performed in exfoliative cytology to evaluate cellular alterations before and after use the foam. After use, the patient also answered a questionnaire about the organoleptic characteristics. The foam formulation presented good acceptance of appearance and consistency for 100% of the patients. G2 showed a reduction of bacteria with a difference of log averages before -0.88 CFU / mL, presenting a statistically significant difference in one use of the product for 1 minute (p <0.05). Group 1 presented a better average salivation increase during the use of the product with a mean of 6.9 with a statistically significant difference between him and group 5 (p <0.05). Topical use of the foam formulation was cytologically and clinically safe at the three concentrations tested. Only the concentration of 0.5% presented a statistically significant perinuclear halo change. These results may have a significant impact on the development of effective, safe and low cost oral health therapy in patients with mucositis and xerostomia.