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

Overview

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.

Full Title of Study: “Efficacy of Standardized-propolis Extract (EPP-AF®) Gel Formulation as Buccal Antiseptic in Elderly People”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2016

Interventions

  • Other: Propolis
  • Drug: Miconazole

Arms, Groups and Cohorts

  • Experimental: Propolis
    • Standardized-propolis extract (EPP-AF®) oral gel formulation, 3 times a day, for 14 days
  • Active Comparator: Miconazole
    • Miconazole 20mg/g oral gel,3 times a day, for 14 days

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • Elderly patients with denture stomatitis Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Sao Paulo
  • Collaborator
    • Financiadora de Estudos e Projetos
  • Provider of Information About this Clinical Study
    • Principal Investigator: Erica Negrini Lia, Pos doctoral – University of Sao Paulo
  • Overall Official(s)
    • Erica N Lia, PhD, Principal Investigator, Faculdade de Medicina de Ribeirão Preto/USP
    • Gisela M Pina, DDS, Principal Investigator, Unievangelica Anapolis

Citations Reporting on Results

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.

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.

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.

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