Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2026-01-25 @ 8:33 AM
Study NCT ID:
NCT03299595
Status:
COMPLETED
Last Update Posted:
2021-01-08
First Post:
2017-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Mucosal Lesions Among Smokers in an Egyptian Population.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'Histopathological evaluation of clinically suspicious oral lesions to detect dysplasia (Warnakulasuriy et al., 2007 and Rastogi et al., 2013).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 824}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-07', 'studyFirstSubmitDate': '2017-09-28', 'studyFirstSubmitQcDate': '2017-10-02', 'lastUpdatePostDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'oral mucosal lesions', 'timeFrame': 'one year', 'description': 'Identifying and recording oral mucosal lesions'}], 'secondaryOutcomes': [{'measure': 'Oral health-related quality of life (OH-QoL) evaluation', 'timeFrame': 'one year', 'description': 'using Oral Health Impact Profile (OHIP)'}, {'measure': 'histopathological evaluation', 'timeFrame': 'one year', 'description': 'light microscope'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smokers']}, 'descriptionModule': {'briefSummary': 'This cross-sectional study will assess the prevalence of oral changes among smokers in an Egyptian cohort (patients attending to the hospital of Faculty of Dentistry - Cairo University), aiming that this study can serve as a baseline for future studies with the goal of finding ways to improve oral health and increase awareness of the hazards of smoking in Egypt', 'detailedDescription': 'The participants will be selected from the pool of the Clinics of Oral Medicine, Periodontology and Diagnosis Department and the Diagnostic center, Faculty of Dentistry - Cairo University. For each eligible participant, a full history will be obtained according to a questionnaire followed by thorough clinical examination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The participants will be selected from the pool of the Clinics of Oral Medicine, Periodontology and Diagnosis Department and the Diagnostic center, Faculty of Dentistry - Cairo University. For each eligible participant, a full history will be obtained according to a questionnaire followed by thorough clinical examination.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gender: males and females.\n* Age: all age groups.\n* Smokers.\n* Individuals who agreed to sign the informed consent.\n\nExclusion Criteria:\n\n* Individuals suffering from any systemic disease.\n* Individuals on medications.\n* Non-Egyptians.'}, 'identificationModule': {'nctId': 'NCT03299595', 'briefTitle': 'Oral Mucosal Lesions Among Smokers in an Egyptian Population.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Prevalence of Oral Mucosal Lesions Among Smokers in an Egyptian Cohort: A Hospital-based Cross-Sectional Study (II)', 'orgStudyIdInfo': {'id': 'CEBC-CU-2017-08-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'printed questionnaire', 'type': 'OTHER', 'description': 'For each eligible participant, a full history will be obtained according to a questionnaire followed by thorough clinical examination.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11728', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Dentistry', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident', 'investigatorFullName': 'Alaa Shousha', 'investigatorAffiliation': 'Cairo University'}}}}