Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT04152005
Status:
COMPLETED
Last Update Posted:
2019-11-06
First Post:
2019-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endothelin Concentrations in a Population With Cardiovascular Disease and Periodonitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-04', 'studyFirstSubmitDate': '2019-11-01', 'studyFirstSubmitQcDate': '2019-11-01', 'lastUpdatePostDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of ET-1 levels', 'timeFrame': '1 year', 'description': 'Correlation of ET-1 levels with periodontal and cardiovascular disease'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Serum; Disease']}, 'descriptionModule': {'briefSummary': 'Recently, a key role played in the ethiology of periodontitis has been highlighted by a Endothelin (ET-1). ET1 possess the ability to express surface antigens of endothelial and hematopoietic stem cells and to assist in maintaining vascular integrity and the repair mechanism of the endothelium. ET originate from bone marrow', 'detailedDescription': 'The aim of the present study was to investigate the association between ET-1 in patients with periodontitis. Furthermore, the objective was to determine if the periodontal status influenced ET-1 levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '71 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '34 patients with CP, 34 patients with CHD, 34 patients with CP+CHD, and 34 healthy subjects were finally enrolled', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of at least 16 teeth\n* CP with a minimum of 40% of sites with a clinical attachment level (CAL)\n\n ≥2mm and probing depth (PD) ≥4mm;\n* Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs\n* Presence of ≥40% sites with bleeding on probing (BOP)\n\nExclusion Criteria:\n\n* Intake of contraceptives\n* Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study\n* Status of pregnancy or lactation\n* Previous history of excessive drinking\n* Allergy to local anaesthetic\n* Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.'}, 'identificationModule': {'nctId': 'NCT04152005', 'briefTitle': 'Endothelin Concentrations in a Population With Cardiovascular Disease and Periodonitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Messina'}, 'officialTitle': 'Analysis of Endothelin Concentrations in a Population With Cardiovascular Disease and Periodontitis', 'orgStudyIdInfo': {'id': '10-918-10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': 'Evaluation of ET-1 level and correlation of ET-1 levels with periodontal and cardiovascular disease', 'interventionNames': ['Other: Observation']}, {'label': 'Periodontitis', 'description': 'Evaluation of ET-1 level and correlation of ET-1 levels with periodontal and cardiovascular disease', 'interventionNames': ['Other: Observation']}, {'label': 'Cardiovascular', 'description': 'Evaluation of ET-1 level and correlation of ET-1 levels with periodontal and cardiovascular disease', 'interventionNames': ['Other: Observation']}, {'label': 'Periodontitis+Cardiovascular', 'description': 'Evaluation of ET-1 level and correlation of ET-1 levels with periodontal and cardiovascular disease', 'interventionNames': ['Other: Observation']}], 'interventions': [{'name': 'Observation', 'type': 'OTHER', 'description': 'Evaluation of ET-1 level and correlation of ET-1 levels with periodontal and cardiovascular disease', 'armGroupLabels': ['Cardiovascular', 'Control', 'Periodontitis', 'Periodontitis+Cardiovascular']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98125', 'city': 'Messina', 'country': 'Italy', 'facility': 'University of Messina', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}], 'overallOfficials': [{'name': 'Giovanni Matarese', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Messina'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '5 years', 'ipdSharing': 'YES', 'description': 'all collected IPD, all IPD that underlie results in a publication', 'accessCriteria': 'IRB university of messina'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Messina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Gaetano Isola, DDS, PhD', 'investigatorAffiliation': 'University of Messina'}}}}