Stomatitis under prosthesis
Conditions
Interventions
Anamnesis and preliminary clinical examination will be performed to verify the absence or presence of signs and symptoms of prosthetic stomatitis. In addition, a mycological laboratory test will be pe
Drug
E02.319
Sponsors
Universidade Federal da Paraíba
Universidade Federal da Paraíba
Eligibility
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: Fase I: The study will include healthy individuals and users of upper removable total prosthesis, belonging to the age group from 40 to 70 years. In order for there to be no confusion of signs and symptoms relevant to possible adverse effects of the test product with signs and symptoms of disease, healthy subjects were selected as defined by the Phase I clinical trial definition. fase II: Individuals belonging to the age group from 40 to 70 years old, with oral candidiasis and dental prosthesis user, with a signed and signed Free and Informed Consent Term.
Exclusion criteria
Exclusion criteria: Fases I e II: Individuals undergoing topical and / or systemic antimicrobial treatment and who have a sensitivity reaction to cinnamaldehyde, cinnamon or Miconazole.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A reduction in the levels of clinical signs of oral candidiasis associated with prosthesis use is expected. Such signs are reddish areas on the hard palate ("sky of the mouth"). Generally asymptomatic, but can present burning, symptomatology painful, pruritus and unpleasant taste. Verified by oral and mycological clinical examination before and after use of the study drug. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to find a reduction in the number of colony forming units of Candida spp. (CFU / mL) in the oral mucosa. Verified by mycological examination using a sterile swab before and after the use of the study drug.;Evaluate whether the product, under the suggested conditions of use, causes adverse effects in the short term. As irritability in the mucosa, burning or allergic reactions. Verified by oral clinical examination. | — |
Countries
Brazil
Contacts
Public ContactDanielle da Nóbrega Alves
Universidade Federal da Paraíba
Outcome results
None listed