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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02818803
Recruitment Status : Completed
First Posted : June 30, 2016
Last Update Posted : June 30, 2016
Financiadora de Estudos e Projetos
Information provided by (Responsible Party):
Erica Negrini Lia, 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.

Condition or disease Intervention/treatment Phase
Candidiasis, Oral Stomatitis, Denture Other: Propolis Drug: Miconazole Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Standardized-propolis Extract (EPP-AF®) Gel Formulation as Buccal Antiseptic in Elderly People
Study Start Date : January 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

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 Name: Daktarin oral gel

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Assessment of gel acceptability [ Time Frame: Day 7 ]
    Application of hedonic scale on day 7

  2. Assessment of adverse events [ Time Frame: Day 7 and 14 ]
    Questioning about rise of adverse events on days 7 and 14

  3. Anti fungal activity [ Time Frame: Day 1 and 14 ]
    Colony forming unit count (CFU/mL) on days 1 and 14

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Elderly patients with denture stomatitis

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02818803

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Unievangelica Anapolis
Anapolis, Goias, Brazil, 75083515
Unidade de Pesquisa Clinica HCRP-USP
Ribeirao Preto, São Paulo, Brazil, 14048900
Sponsors and Collaborators
University of Sao Paulo
Financiadora de Estudos e Projetos
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Principal Investigator: Erica N Lia, PhD Faculdade de Medicina de Ribeirão Preto/USP
Principal Investigator: Gisela M Pina, DDS Unievangelica Anapolis
Publications of Results:
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Responsible Party: Erica Negrini Lia, Pos doctoral, University of Sao Paulo Identifier: NCT02818803    
Other Study ID Numbers: 1057529
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: June 30, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Erica Negrini Lia, University of Sao Paulo:
denture stomatitis
Additional relevant MeSH terms:
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Candidiasis, Oral
Stomatitis, Denture
Mouth Diseases
Stomatognathic Diseases
Anti-Infective Agents
Antifungal Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors