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

NCT ID: NCT02818803

Last Updated: 2016-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-06-30

Brief Summary

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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

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Conditions

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Candidiasis, Oral Stomatitis, Denture

Keywords

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propolis therapeutic miconazole denture stomatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Propolis

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

Group Type EXPERIMENTAL

Propolis

Intervention Type OTHER

Miconazole

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

Group Type ACTIVE_COMPARATOR

Miconazole

Intervention Type DRUG

Interventions

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Propolis

Intervention Type OTHER

Miconazole

Intervention Type DRUG

Other Intervention Names

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Daktarin oral gel

Eligibility Criteria

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Inclusion Criteria

* Elderly patients with denture stomatitis

Exclusion Criteria

* Recent use of anti fungals or antibiotics(2 months or less), dementia
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Financiadora de Estudos e Projetos

OTHER

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Erica Negrini Lia

Pos doctoral

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erica N Lia, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculdade de Medicina de Ribeirão Preto/USP

Gisela M Pina, DDS

Role: PRINCIPAL_INVESTIGATOR

Unievangelica Anapolis

Locations

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Unievangelica Anapolis

Anápolis, Goiás, Brazil

Site Status

Unidade de Pesquisa Clinica HCRP-USP

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type RESULT
PMID: 26916845 (View on PubMed)

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.

Reference Type RESULT
PMID: 18696746 (View on PubMed)

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.

Reference Type RESULT
PMID: 16161031 (View on PubMed)

Other Identifiers

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1057529

Identifier Type: -

Identifier Source: org_study_id