Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:11 AM
Study NCT ID:
NCT05101434
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2021-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gingivitis and Periodontitis as a Risk Factor for Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005891', 'term': 'Gingivitis'}, {'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-29', 'studyFirstSubmitDate': '2021-10-18', 'studyFirstSubmitQcDate': '2021-10-29', 'lastUpdatePostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gingivitis', 'timeFrame': 'baseline', 'description': 'Measurement of bleeding site while probing and this was done with gingival index'}, {'measure': 'Periodonitis', 'timeFrame': 'baseline', 'description': 'Measurement of periodontal pockets while probing and this was done with community periodontal idex'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingivitis', 'Periodontitis', 'Stroke']}, 'descriptionModule': {'briefSummary': 'Periodontitis and gingivitis are one of the most infectious diseases in humans. Several studies have been carried out on the dependence of periodontitis and stroke. The aim of this study was to investigate gingivitis and periodontitis as risk factors for stroke in the Pakistani population.', 'detailedDescription': 'Epidemiologic studies have shown that cerebrovascular accident (CVA) is the 3rd cause of death in developed countries with 0.8 % prevalence in the whole population. Although, the prevalence rate of stroke is reduced yet is one of the most important health problems in the United State. Periodontitis and gingivitis are the two most infectious man diseases. Today, it is estimated that about 35% of people over 30-year-old in America and 50-55% of people in developing countries are involved with these diseases.\n\nThese diseases are due to the practice of chronic bacterial infection and the inflammatory response of the host. The relationship between periodontitis and CVA was first introduced by Mackenzi and Millard in 1963 but the importance of this issue was not understood. Periodontal infection can be a complex multiphase disease by associating this infection with organ systems such as cardiovascular, endocrine, reproductive, and respiratory systems. Nowadays, periodontitis is considered a risk factor for atherosclerosis and thromboembolic disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All the patients with stroke (both ischemic and hemorrhagic)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed stroke by using brain imaging from magnetic resonance imaging and/or computerized tomography.\n\nExclusion Criteria:\n\n* Not willing to participate\n* Neurological complications other than stroke'}, 'identificationModule': {'nctId': 'NCT05101434', 'briefTitle': 'Gingivitis and Periodontitis as a Risk Factor for Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Shaheed Zulfiqar Ali Bhutto Medical University'}, 'officialTitle': 'Gingivitis and Periodontitis as a Risk Factor for Stroke', 'orgStudyIdInfo': {'id': 'Gingivitis and Stroke'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Periodontal Probing', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['ROAG revised oral assessment guide', 'Community periodontal index', 'Gingival Index'], 'description': 'with the help Michigan probe, periodontal pocket measurement was done.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'Islamabad', 'state': 'Capital', 'country': 'Pakistan', 'facility': 'Shaheed Zulfiqar Ali Bhutto Medical University', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}], 'overallOfficials': [{'name': 'Muhammad Hassan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shaheed Zulfiqar Ali Bhutto Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data will be shared on reasonable demand'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shaheed Zulfiqar Ali Bhutto Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Registrar Neurology', 'investigatorFullName': 'Muhammad Hassan', 'investigatorAffiliation': 'Shaheed Zulfiqar Ali Bhutto Medical University'}}}}