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NCT Number: NCT02818803

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

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.

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Key information

Conditions

Candidiasis, Oral Bacterial Infections and Mycoses Candidiasis Infections Mouth Diseases Mycoses Stomatitis Stomatitis, Denture Stomatognathic Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Unievangelica Anapolis, Anápolis, Goiás, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elderly patients with denture stomatitis

Exclusion criteria

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

Treatment and study plan

Propolis

Other

miconazole

Drug

Other names: Daktarin oral gel

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Financiadora de Estudos e Projetos

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 30, 2016
Registry last updated
Jun 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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