Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-28 @ 12:49 PM
Study NCT ID:
NCT02818803
Status:
COMPLETED
Last Update Posted:
2016-06-30
First Post:
2016-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Standardized-propolis Extract (EPP-AF®) Gel Formulation as Buccal Antiseptic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002180', 'term': 'Candidiasis, Oral'}, {'id': 'D013282', 'term': 'Stomatitis, Denture'}], 'ancestors': [{'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D013280', 'term': 'Stomatitis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011429', 'term': 'Propolis'}, {'id': 'D008825', 'term': 'Miconazole'}], 'ancestors': [{'id': 'D012116', 'term': 'Resins, Plant'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D053147', 'term': 'Plant Exudates'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-27', 'studyFirstSubmitDate': '2016-06-21', 'studyFirstSubmitQcDate': '2016-06-27', 'lastUpdatePostDateStruct': {'date': '2016-06-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Newton Score at 14 days', 'timeFrame': 'Day 14', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Assessment of gel acceptability', 'timeFrame': 'Day 7', 'description': 'Application of hedonic scale on day 7'}, {'measure': 'Assessment of adverse events', 'timeFrame': 'Day 7 and 14', 'description': 'Questioning about rise of adverse events on days 7 and 14'}, {'measure': 'Anti fungal activity', 'timeFrame': 'Day 1 and 14', 'description': 'Colony forming unit count (CFU/mL) on days 1 and 14'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['propolis', 'therapeutic', 'miconazole', 'denture stomatitis'], 'conditions': ['Candidiasis, Oral', 'Stomatitis, Denture']}, 'referencesModule': {'references': [{'pmid': '26916845', 'type': 'RESULT', 'citation': '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': '18696746', 'type': 'RESULT', 'citation': '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': '16161031', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elderly patients with denture stomatitis\n\nExclusion Criteria:\n\n* Recent use of anti fungals or antibiotics(2 months or less), dementia'}, 'identificationModule': {'nctId': 'NCT02818803', 'briefTitle': 'Efficacy of Standardized-propolis Extract (EPP-AF®) Gel Formulation as Buccal Antiseptic', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Efficacy of Standardized-propolis Extract (EPP-AF®) Gel Formulation as Buccal Antiseptic in Elderly People', 'orgStudyIdInfo': {'id': '1057529'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Propolis', 'description': 'Standardized-propolis extract (EPP-AF®) oral gel formulation, 3 times a day, for 14 days', 'interventionNames': ['Other: Propolis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Miconazole', 'description': 'Miconazole 20mg/g oral gel,3 times a day, for 14 days', 'interventionNames': ['Drug: Miconazole']}], 'interventions': [{'name': 'Propolis', 'type': 'OTHER', 'armGroupLabels': ['Propolis']}, {'name': 'Miconazole', 'type': 'DRUG', 'otherNames': ['Daktarin oral gel'], 'armGroupLabels': ['Miconazole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75083515', 'city': 'Anápolis', 'state': 'Goiás', 'country': 'Brazil', 'facility': 'Unievangelica Anapolis', 'geoPoint': {'lat': -16.32667, 'lon': -48.95278}}, {'zip': '14048900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Unidade de Pesquisa Clinica HCRP-USP', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}], 'overallOfficials': [{'name': 'Erica N Lia, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculdade de Medicina de Ribeirão Preto/USP'}, {'name': 'Gisela M Pina, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unievangelica Anapolis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Financiadora de Estudos e Projetos', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pos doctoral', 'investigatorFullName': 'Erica Negrini Lia', 'investigatorAffiliation': 'University of Sao Paulo'}}}}