NCT02818803

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 30, 2016

Completed
Last Updated

June 30, 2016

Status Verified

June 1, 2016

Enrollment Period

5 months

First QC Date

June 21, 2016

Last Update Submit

June 27, 2016

Conditions

Candidiasis, OralStomatitis, Denture

Keywords

propolistherapeuticmiconazoledenture stomatitis

Outcome Measures

Primary Outcomes (1)

  • Change from Newton Score at 14 days

    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 Outcomes (3)

  • Assessment of gel acceptability

    Day 7

  • Assessment of adverse events

    Day 7 and 14

  • Anti fungal activity

    Day 1 and 14

Study Arms (2)

Propolis

EXPERIMENTAL

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

Other: Propolis

Miconazole

ACTIVE COMPARATOR

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

Drug: Miconazole

Interventions

PropolisOTHER
Propolis
MiconazoleDRUG
Also known as: Daktarin oral gel
Miconazole

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elderly patients with denture stomatitis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unievangelica Anapolis

Anápolis, Goiás, 75083515, Brazil

Location

Unidade de Pesquisa Clinica HCRP-USP

Ribeirão Preto, São Paulo, 14048900, Brazil

Location

Related Publications (3)

  • 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.

    PMID: 26916845RESULT

  • 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.

    PMID: 18696746RESULT

  • 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.

    PMID: 16161031RESULT

MeSH Terms

Conditions

Candidiasis, OralStomatitis, Denture

Interventions

PropolisMiconazole

Condition Hierarchy (Ancestors)

CandidiasisMycosesBacterial Infections and MycosesInfectionsMouth DiseasesStomatognathic DiseasesStomatitis

Intervention Hierarchy (Ancestors)

Resins, PlantBiopolymersPolymersMacromolecular SubstancesPlant ExudatesBiological ProductsComplex MixturesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Erica N Lia, PhD

    Faculdade de Medicina de Ribeirão Preto/USP

    PRINCIPAL INVESTIGATOR

  • Gisela M Pina, DDS

    Unievangelica Anapolis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pos doctoral

Study Record Dates

First Submitted

June 21, 2016

First Posted

June 30, 2016

Study Start

January 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

June 30, 2016

Record last verified: 2016-06

Locations

BR(2)