Avaliação antimicrobiana e prevenção de lesões de cárie dentária com o uso do dentifrício de própolis vermelha brasileira: estudo laboratorial e ensaio clínico randomizado

Abstract

The development of dental formulations with propolis is a growing reality in the pharmaceutical industry, especially for diseases related to biofilm. This study evaluated in vitro and in vivo the use of fluoridated toothpaste containing 1% Brazilian red propolis (BRP) in controlling marginal bleeding and preventing caries lesions in orthodontic patients. In the in vitro phase, the antimicrobial activity of the BRP extract and the toothpaste incorporating the extract was evaluated against Streptococcus mutans ATCC UA159. The clinical phase consisted of a randomized, double-blind, controlled, longitudinal clinical trial involving 60 orthodontic patients aged 12 to 18 years, followed for a period of six months. Participants were divided into two groups: a test group (toothpaste with BRP + 1500 ppm fluoride) and a control group (toothpaste with 1500 ppm fluoride). Clinical assessments were performed at baseline, and at 2, 4, and 6 months, using the ICDAS II criteria for detecting carious lesions and the gingival bleeding index. Statistical analyses were performed using the Kruskal-Wallis and Mann-Whitney tests, and significance adjustment was performed using the Bonferroni method, considering a significance level of 5%. The results demonstrated that both the PVB extract and the toothpaste containing PVB showed significant antimicrobial activity, with a reduction in bacterial viability up to a concentration of 0.3906 µg/mL (p < 0.05). The minimum bactericidal effect (MBC) was observed at a concentration of 1.5625 µg/mL for both groups. No statistically significant differences were observed between the PVB extract and the toothpaste formulated with the extract (p > 0.05), indicating that the incorporation process did not compromise the antimicrobial activity. The commercial toothpaste Parodontax® showed antimicrobial activity in all dilutions tested, with MBC equivalent to that of PVB (1.5625 µg/mL), showing greater overall antimicrobial potency (p < 0.05). These findings confirm the ability of PVB to directly interfere with the viability of cariogenic microorganisms. In the clinical phase, the results demonstrated that the group using the toothpaste containing PVB maintained a higher proportion of healthy surfaces (ICDAS II = 0) throughout the follow-up, while the control group showed significant progression to initial lesions (ICDAS II = 1), with a statistically significant difference between the groups (p ≤ 0.05). Regarding gingival condition, a significant reduction in the gingival bleeding index was observed in the PVB group at 4 and 6 months of follow-up (p ≤ 0.05), contrasting with the progressive increase observed in the control group. The in vitro and clinical results demonstrate that the fluoridated toothpaste containing PVB has antimicrobial activity, associated with significant clinical benefits in the prevention of initial caries and in the control of gingival inflammation in orthodontic patients. The combination of PVB with fluoride proved to be effective, safe, and biocompatible, without compromising traditional anti-caries action, consolidating this toothpaste as a promising preventive strategy for managing dental biofilm in at-risk populations.