Efficacy of Standardized-propolis Extract (EPP-AF®) Gel Formulation as Buccal Antiseptic

University of Sao Paulo

Status and phase: Completed; Phase 3

Conditions: Stomatitis, Denture; Candidiasis, Oral

Treatments: Other: Propolis; Drug: Miconazole

Study type: Interventional

Funder types: Other

Identifiers

NCT02818803

1057529

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elderly patients with denture stomatitis

Exclusion criteria

• Recent use of anti fungals or antibiotics(2 months or less), dementia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Propolis

Experimental group

Description:

Standardized-propolis extract (EPP-AF®) oral gel formulation, 3 times a day, for 14 days

Treatment:

Other: Propolis

Miconazole

Active Comparator group

Description:

Miconazole 20mg/g oral gel,3 times a day, for 14 days

Treatment:

Drug: Miconazole