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EFFICACY OF PROPOLIS ON DENTURE STOMATITIS IN OLDER ADULTS: A MULTICENTRIC RANDOMIZED TRIAL


ABSTRACT: Abstract Our hypothesis tested the efficacy and safety of standard formulation of Brazilian propolis extract gel compared to miconazole oral gel for the treatment of denture stomatitis due Candida spp infection in older adults. A total of 40 older patients were randomly allocated in a non-inferiority clinical trial (NCT02818803) into two groups. The control group (MIC) received 20?mg/g miconazole oral gel and the study group (PROP) received mucoadhesive formulation containing standardized extract of 2% propolis (EPP-AF®) during 14 days. Patients were examined by a dentist on days 1, 7 and 14. The Newton’s score was used to assess the denture stomatitis. The colony forming unity count (CFU/mL) was quantified and compared before and after the treatment (days 1 and 14). Age, gender, duration of complete denture’s use, baseline Newton’s score, and baseline CFU/mL did not differ between groups. Both treatments reduced the Newton’s score (P<0.0001). Miconazole, but not propolis, reduced the CFU (6.2x103 vs. 10 CFU/mL, D1 vs. D14; P<0.001). The candidiasis cure rate, defined as both absence of oral lesions and a negative culture for Candida, was only 30% for miconazole and 20% for EPP-AF® group. Both treatments resulted in improvement of the clinical symptoms of candidiasis, showing a clinical cure rate of 0.60 for miconazole and 0.50 for propolis. No serious adverse events were observed in neither group. The EPP-AF® appears to be non-inferior to miconazole considering the clinical cure rate and could be recommended as an alternative treatment for oral candidiasis in older patients. Finantial support: FINEP(Brazil)/CNPq

SUBMITTER: Pina G 

PROVIDER: S-EPMC6244471 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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