The purpose of this study is to evaluate the efficacy and safety of propolis on the treatment of oral candidiasis, more specifically denture stomatitis. Half of participants will receive a standardized-propolis (EPP-AF®) gel formulation while the other half will receive miconazole gel, both for oral use.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Unievangelica Anapolis
Anápolis, Goiás, Brazil
Unidade de Pesquisa Clinica HCRP-USP
Ribeirão Preto, São Paulo, Brazil
Change from Newton Score at 14 days
Clinical assessment of buccal lesions localized at hard palate. The score utilized to measure the intensity of lesions will be Newton classification (I - punctate in the palate; II - extensive smooth reddened appearance; III -extensive reddening with hyperplastic growth) and the outcome will be the reduction of Newton's score comparing day 1 with day 14.
Time frame: Day 14
Assessment of gel acceptability
Application of hedonic scale on day 7
Time frame: Day 7
Assessment of adverse events
Questioning about rise of adverse events on days 7 and 14
Time frame: Day 7 and 14
Anti fungal activity
Colony forming unit count (CFU/mL) on days 1 and 14
Time frame: Day 1 and 14
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