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| Name | Class |
|---|---|
| Financiadora de Estudos e Projetos | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propolis | Experimental | Standardized-propolis extract (EPP-AF®) oral gel formulation, 3 times a day, for 14 days |
|
| Miconazole | Active Comparator | Miconazole 20mg/g oral gel,3 times a day, for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propolis | Other |
| ||
| Miconazole |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of gel acceptability | Application of hedonic scale on day 7 | Day 7 |
| Assessment of adverse events | Questioning about rise of adverse events on days 7 and 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erica N Lia, PhD | Faculdade de Medicina de Ribeirão Preto/USP | Principal Investigator |
| Gisela M Pina, DDS | Unievangelica Anapolis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unievangelica Anapolis | Anápolis | Goiás | 75083515 | Brazil | ||
| Unidade de Pesquisa Clinica HCRP-USP |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26916845 | Result | Freires IA, Queiroz VCPP, Furletti VF, Ikegaki M, de Alencar SM, Duarte MCT, Rosalen PL. Chemical composition and antifungal potential of Brazilian propolis against Candida spp. J Mycol Med. 2016 Jun;26(2):122-132. doi: 10.1016/j.mycmed.2016.01.003. Epub 2016 Feb 23. | |
| 18696746 | Result | Santos VR, Gomes RT, de Mesquita RA, de Moura MD, Franca EC, de Aguiar EG, Naves MD, Abreu JA, Abreu SR. Efficacy of Brazilian propolis gel for the management of denture stomatitis: a pilot study. Phytother Res. 2008 Nov;22(11):1544-7. doi: 10.1002/ptr.2541. |
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| ID | Term |
|---|---|
| D002180 | Candidiasis, Oral |
| D013282 | Stomatitis, Denture |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D011429 | Propolis |
| D008825 | Miconazole |
| ID | Term |
|---|---|
| D012116 | Resins, Plant |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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|
|
| Day 7 and 14 |
| Anti fungal activity | Colony forming unit count (CFU/mL) on days 1 and 14 | Day 1 and 14 |
| Ribeirão Preto |
| São Paulo |
| 14048900 |
| Brazil |
| 16161031 | Result | Santos VR, Pimenta FJ, Aguiar MC, do Carmo MA, Naves MD, Mesquita RA. Oral candidiasis treatment with Brazilian ethanol propolis extract. Phytother Res. 2005 Jul;19(7):652-4. doi: 10.1002/ptr.1715. |
| D009059 |
| Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D013280 | Stomatitis |
| D053147 |
| Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |