Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-02-18 @ 5:44 AM
Study NCT ID:
NCT02166450
Status:
UNKNOWN
Last Update Posted:
2014-06-19
First Post:
2014-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Denture-Related Stomatitis on Blood Pressure in Denture Wearers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013282', 'term': 'Stomatitis, Denture'}], 'ancestors': [{'id': 'D013280', 'term': 'Stomatitis'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009761', 'term': 'Nystatin'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'lastUpdateSubmitDate': '2014-06-18', 'studyFirstSubmitDate': '2014-06-13', 'studyFirstSubmitQcDate': '2014-06-16', 'lastUpdatePostDateStruct': {'date': '2014-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in blood pressure', 'timeFrame': 'Within 48h Prior to denture-related stomatitis treatment; 48h after recovery from denture-related stomatitis; 2 months after recovery from denture-related stomatitis', 'description': 'Ambulatory Blood Pressure Monitoring System'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in endothelial function', 'timeFrame': 'Within 48h Prior to denture-related stomatitis treatment; 48h after recovery from denture-related stomatitis; 2 months after recovery from denture-related stomatitis', 'description': 'Flow Mediated Dilatation'}, {'measure': 'Changes in immune cell subset populations from baseline', 'timeFrame': 'Within 48h Prior to denture-related stomatitis treatment; 48h after recovery from denture-related stomatitis; 2 months after recovery from denture-related stomatitis', 'description': 'Determination of cell subsets, activation markers and intracellular cytokine production'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Denture stomatitis', 'Dentures', 'Denture wearers'], 'conditions': ['Denture Stomatitis']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the influence of presence of oral fungal infection, which leads to denture-related stomatitis, on blood pressure, endothelial function and immune cell phenotype in patients wearing dentures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Dental clinic patients wearing dentures', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with dental prostheses used for at least 6 months,\n* Substantial portion of the oral mucosa covered by dental prosthesis.\n\nExclusion Criteria:\n\n* acute inflammatory disorders other than denture-related stomatitis, neoplastic disease relapses or chemotherapy courses less than 5 years before the enrolment,\n* antibiotics in less than 4 weeks before the enrolment,\n* anti-inflammatory drugs (steroids and non-steroidal, excluding aspirin in doses less than 80 mg) in less than 2 months before the enrolment,\n* history of myocardial infarction, acute coronary incident or vascular inflammation in 5 weeks or less before the enrolment,\n* chronic haematological disorders and immunodeficiencies less than 5 weeks before the enrolment,\n* major medication changes less than 5 weeks before the enrolment or during study.'}, 'identificationModule': {'nctId': 'NCT02166450', 'briefTitle': 'Effects of Denture-Related Stomatitis on Blood Pressure in Denture Wearers', 'organization': {'class': 'OTHER', 'fullName': 'Jagiellonian University'}, 'officialTitle': 'Effects of Denture-Related Stomatitis on Blood Pressure, Endothelial Function and Systemic Immune Response in Patients With Dentures', 'orgStudyIdInfo': {'id': 'DRS-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group', 'description': 'Denture wearers without clinical signs of denture-related stomatitis confirmed with negative Candida swabs.'}, {'label': 'Denture-related stomatitis group', 'description': 'Denture wearers with clinical signs of denture-related stomatitis, confirmed with positive Candida swabs.\n\nTreated for fungal infection, with nystatin \\[100 000 IU every 6 h for 3 weeks, applied on the infected area of the mucous membrane of the palate and cheeks\\].', 'interventionNames': ['Drug: Nystatin']}], 'interventions': [{'name': 'Nystatin', 'type': 'DRUG', 'otherNames': ['Mycostatin', 'Stamicin', 'Stamycin', 'Fungicidin', 'Nilstat'], 'description': '100 000 IU every 6 h as a suspension', 'armGroupLabels': ['Denture-related stomatitis group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31-135', 'city': 'Krakow', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Zbigniew Żak Voivodeship Dental Clinic', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '31-155', 'city': 'Krakow', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Jagiellonian University Dental Clinic', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}], 'centralContacts': [{'name': 'Marta Cześnikiewicz-Guzik, PhD', 'role': 'CONTACT', 'email': 'marta.czesnikiewicz-guzik@glasgow.ac.uk', 'phone': '+48126330003'}], 'overallOfficials': [{'name': 'Tomasz Guzik, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jagiellonian University'}, {'name': 'Marta Cześnikiewicz-Guzik, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jagiellonian University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jagiellonian University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Tomasz Guzik', 'investigatorAffiliation': 'Jagiellonian University'}}}}