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

June 27, 2016 updated by: Erica Negrini Lia, University of Sao Paulo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Goias
      • Anapolis, Goias, Brazil, 75083515
        • Unievangelica Anapolis
    • São Paulo
      • Ribeirao Preto, São Paulo, Brazil, 14048900
        • Unidade de Pesquisa Clínica HCRP-USP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elderly patients with denture stomatitis

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Propolis
Standardized-propolis extract (EPP-AF®) oral gel formulation, 3 times a day, for 14 days
Other: Propolis
Active Comparator: Miconazole
Miconazole 20mg/g oral gel,3 times a day, for 14 days
Drug: Miconazole
Other Names:
  • Daktarin oral gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Newton Score at 14 days
Time Frame: 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.
Day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of gel acceptability
Time Frame: Day 7
Application of hedonic scale on day 7
Day 7
Assessment of adverse events
Time Frame: Day 7 and 14
Questioning about rise of adverse events on days 7 and 14
Day 7 and 14
Anti fungal activity
Time Frame: Day 1 and 14
Colony forming unit count (CFU/mL) on days 1 and 14
Day 1 and 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Financiadora de Estudos e Projetos

Investigators

  • Principal Investigator: Erica N Lia, PhD, Faculdade de Medicina de Ribeirão Preto/USP
  • Principal Investigator: Gisela M Pina, DDS, Unievangelica Anapolis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

June 21, 2016

First Submitted That Met QC Criteria

June 27, 2016

First Posted (Estimate)

June 30, 2016

Study Record Updates

Last Update Posted (Estimate)

June 30, 2016

Last Update Submitted That Met QC Criteria

June 27, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1057529

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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