Candidiasis, Oral, Stomatitis, Denture
Conditions
Keywords
propolis, therapeutic, miconazole, denture stomatitis
Brief summary
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.
Interventions
OTHERPropolis
DRUGMiconazole
Sponsors
Financiadora de Estudos e Projetos
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Elderly patients with denture stomatitis
Exclusion criteria
* Recent use of anti fungals or antibiotics(2 months or less), dementia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Newton Score at 14 days | Day 14 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of gel acceptability | Day 7 | Application of hedonic scale on day 7 |
| Assessment of adverse events | Day 7 and 14 | Questioning about rise of adverse events on days 7 and 14 |
| Anti fungal activity | Day 1 and 14 | Colony forming unit count (CFU/mL) on days 1 and 14 |
Countries
Brazil
Outcome results
None listed