Desenvolvimento, caracterização e a avaliação clínica de gel contendo nanocápsulas poliméricas de eugenol na sensibilidade decorrente do clareamento dental.

Abstract

Tooth whitening is one of the most sought-after cosmetic procedures in Dentistry. Despite being an easy-to-handle technique, many patients do not adapt to the use of a tray for at-home bleaching and opt for in-office bleaching. On the other hand, this may present a high index of sensitivity tooth (ST) due to the higher concentration of the whitening gel and for this reason, some drugs, for systemic and/or topical use, were tested, but none of them managed to eliminate ST completely. Given the above, the study aimed to develop and evaluate polymeric nanocapsules containing eugenol (NC-E) in DS from polymer EUD RS100 and clinically evaluate the effectiveness of a gel containing NC-E against tooth sensitivity. Polymeric nanocapsules were developed using the preformed polymer interfacial deposition method. Polymeric systems were characterized through morphological, spectroscopic and thermal studies. The physicochemical stability of the formulations was evaluated over a period of 120 days. The analytical method for the determination of eugenol in formulations was validated as recommended by the National Health Surveillance Agency and The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. The nanocapsule gel was developed and organoleptic characterization performed, physicochemical and rheological analysis. Polymeric nanocapsules containing eugenol (NC-E) and control nanocapsules without eugenol (NC-C) were successfully prepared by the chosen technique. NC-E and NC-C were predominantly spherical in shape with a smooth and regular surface and mean particle size of approximately 125 nm, polydispersion index below 0.3 and zeta potential below +30 mV. Fourier Transform Infrared spectra ensured that the nanoencapsulation process did not result in significant chemical bonds between eugenol and the polymer. NC-E and NC-C remained stable up to a period of 60 days, when changes in zeta potential began to change significantly. The formulations presented encapsulation efficiency above 90%, and the analytical method used proved to be linear for the proposed application range, precise, accurate and robust, being able to quantify the nanoencapsulated eugenol in polymeric systems, providing results reliable. The quality control of the desensitizing gel containing NC-E (NC-E gel) manipulated for use in the clinic did not show significant differences during 90 days of storage. Rheology analyzes demonstrated that the gel containing NC-E has a lower viscosity than the control gel when subjected to high rotation frequencies. The administration of 1% NC-E gel in patients did not show results in reducing the absolute risk and intensity of DS and also did not show color change.