Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-03-01 @ 12:20 AM
Study NCT ID:
NCT02394860
Status:
TERMINATED
Last Update Posted:
2025-08-03
First Post:
2014-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Periodontal Diseases on Vascular Parameters in Patients Suffering of Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055113', 'term': 'Chronic Periodontitis'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'no patient', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2014-07-08', 'studyFirstSubmitQcDate': '2015-03-16', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measuring the thickness of the intima-media', 'timeFrame': '15 days'}], 'secondaryOutcomes': [{'measure': 'Evaluation of anatomical changes that may occur at the arterial level', 'timeFrame': 'Within 15 days after inclusion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Periodontitis', 'Hypertension']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the influence of the severity of chronic periodontitis on hemodynamic parameters in hypertensive patients.Secondary purposes of this protocol is to identify evolution of several biomarkers and correlate the clinical situation with oral microflora.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Will be included men with severe and moderate periodontitis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* -Men- \\>40 years\n* moderate and severe generalized chronic periodontitis\n* Former diagnosis of hypertension\n* \\>12 teeth\n\nExclusion Criteria:\n\n* \\>70 years\n* smokers (\\>10 cig/day)\n* body mass index\\>30\n* Need of antibioprophylaxis\n* Medical treatment including anti-inflammatory drugs and/or antibiotics\n* Refractory form of hypertension- aggressive periodontitis'}, 'identificationModule': {'nctId': 'NCT02394860', 'briefTitle': 'Influence of Periodontal Diseases on Vascular Parameters in Patients Suffering of Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Influence of Periodontal Diseases on Hemodynamic and Molecular Vascular Parameters in Patients Suffering of Hypertension', 'orgStudyIdInfo': {'id': '5883'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'blood and cardiological examination', 'interventionNames': ['Other: echo Doppler lower limbs']}], 'interventions': [{'name': 'echo Doppler lower limbs', 'type': 'OTHER', 'armGroupLabels': ['blood and cardiological examination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Service de parodontologie', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Olivier HUCK, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU Strasbourg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}