Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT04047212
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-06-16
First Post:
2019-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Link Between Periodontitis, Smoking and Oral Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Saudi Arabia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D055113', 'term': 'Chronic Periodontitis'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}], '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': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'biopsy of cases having oral lesions'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-08-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2032-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-13', 'studyFirstSubmitDate': '2019-08-03', 'studyFirstSubmitQcDate': '2019-08-03', 'lastUpdatePostDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-10-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Periodontitis', 'timeFrame': 'the 10 years of the study', 'description': 'arising of periodontitis or increase in the grade of an already existing case of periodontitis'}], 'secondaryOutcomes': [{'measure': 'Oral cancer', 'timeFrame': 'the 10 years of the study', 'description': 'Arising of a lesion of oral cancer or a premalignant lesion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Periodontitis', 'Oral Cancer']}, 'descriptionModule': {'briefSummary': 'Periodontitis is a widely prevalent disease worldwide that has serious public health consequences. Its prognosis includes tooth loss and edentulism, a condition that negatively affects chewing causing functional disability; and esthetics causing social impairment. Consequently, periodontitis may end up causing marked impairment of the quality of life of the affected patients, impairment of general health and increasing the dental care costs significantly.\n\nChanges in the oral mucosa arise by primary products resulting from tissue breakdown due to gingivitis. It then triggers the host cells to produce proteinases that mediate loss of marginal periodontal ligaments, apical migration of the junctional epithelium and apical spread of bacterial biofilm.\n\nTherefore, this research aims to identify the risk of smoking to both periodontitis and oral cancer, and the risk of periodontitis to oral cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult individuals', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 years or older.\n\nExclusion Criteria:\n\n* Patients with any systemic diseases.\n* Pregnant females.\n* Handicapped and mentally retarded patients.\n* Patients undergoing radiotherapy.\n* Patients having oral cancer'}, 'identificationModule': {'nctId': 'NCT04047212', 'briefTitle': 'The Link Between Periodontitis, Smoking and Oral Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Analysis of the Link Between Periodontitis, Smoking and Oral Cancer: Cohort Study', 'orgStudyIdInfo': {'id': 'P12'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Smokers', 'interventionNames': ['Diagnostic Test: biopsy for oral cancer', 'Diagnostic Test: periodontal examination']}, {'label': 'non-Smokers', 'interventionNames': ['Diagnostic Test: biopsy for oral cancer', 'Diagnostic Test: periodontal examination']}], 'interventions': [{'name': 'biopsy for oral cancer', 'type': 'DIAGNOSTIC_TEST', 'description': 'surgical biopsy is to be taken for diagnosis of oral cancer or premalignant lesions', 'armGroupLabels': ['Smokers', 'non-Smokers']}, {'name': 'periodontal examination', 'type': 'DIAGNOSTIC_TEST', 'description': 'Periodontal clinical examination to all by periodontal charting', 'armGroupLabels': ['Smokers', 'non-Smokers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Cairo', 'country': 'Egypt', 'contacts': [{'name': 'Ayat A Gamal-AbdelNaser', 'role': 'CONTACT', 'email': 'ayat.gamal@dentistry.cu.edu.eg', 'phone': '01001874257'}], 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ayat Gamal-AbdelNaser', 'role': 'CONTACT', 'email': 'ayat.gamal@dentistry.cu.edu.eg', 'phone': '01001874257'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ayat Gamal-AbdelNaser', 'investigatorAffiliation': 'Cairo University'}}}}