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

Phase 3

Completed

• Conditions: Candidiasis, Oral; Stomatitis, Denture
• Interventions: Other: Propolis; Drug: Miconazole

• Registration Number: NCT02818803
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Status Verified: 2016-06
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-06-27
• Last Update Submitted: 2016-06-27
• Study First Posted: 2016-06-30
• Last Update Posted: 2016-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Elderly patients with denture stomatitis

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propolis	Propolis	Standardized-propolis extract (EPP-AF®) oral gel formulation, 3 times a day, for 14 days
Miconazole	Miconazole	Miconazole 20mg/g oral gel,3 times a day, for 14 days

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Unidade de Pesquisa Clinica HCRP-USP; 🇧🇷 Ribeirao Preto, São Paulo, Brazil

Unievangelica Anapolis; 🇧🇷 Anapolis, Goias, Brazil