Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT05325918
Status:
COMPLETED
Last Update Posted:
2022-04-14
First Post:
2022-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HIF-1 Alpha, VEGF and MMP-8 Levels in PICF of Smokers Versus Non Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057873', 'term': 'Peri-Implantitis'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Peri-implant crevicular fluid samples collected using periopaper strips'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-13', 'studyFirstSubmitDate': '2022-04-06', 'studyFirstSubmitQcDate': '2022-04-06', 'lastUpdatePostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of levels of HIF-1 Alpha, VEGF and MMP-8 in peri-implant crevicular fluid', 'timeFrame': 'Baseline', 'description': 'Markers collected using periopaper strips'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gingival crevicular fluid', 'Smoking', 'inflammation'], 'conditions': ['Peri-Implantitis']}, 'descriptionModule': {'briefSummary': 'Smoking is a major risk factor for developing peri-implantitis so the current study is comparing inflammatory markers in smokers versus non smokers to know if they have a potential role in pathogenesis of peri-implantitis', 'detailedDescription': 'Peri -implant crevicular fluid was obtained from seven smoker patients and then compared to peri-implant crevicular fluid from seven non smoker individuals.\n\nThe peri-implant crevicular fluid was obtained using periopaper strips then analyzed using ELISA kits of these markers; HIF-1 Alpha, VEGF and MMP-8'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Smoker patients with restored implants', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medically free patients\n* Individuals with restored implants placed one year or more before study enrollment\n* Both genders\n* Age range 20-50 years old\n\nExclusion Criteria:\n\n* Pregnant Females\n* Lactating females'}, 'identificationModule': {'nctId': 'NCT05325918', 'briefTitle': 'HIF-1 Alpha, VEGF and MMP-8 Levels in PICF of Smokers Versus Non Smokers', 'organization': {'class': 'OTHER', 'fullName': 'Future University in Egypt'}, 'officialTitle': 'HIF-1 Alpha, VEGF and MMP-8 Levels in Peri-implant Crevicular Fluid of Smokers Versus Non Smokers', 'orgStudyIdInfo': {'id': 'FUE13'}}, 'contactsLocationsModule': {'locations': [{'zip': '11835', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of oral and dental medicine,FUE, Cairo,Egypt', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Sarah M Elkot, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer of Oral Medicine and Periodontology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Future University in Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Oral Medicine, Periodontology and Diagnosis, Faculty of Oral and Dental Medicine, Future University in Egypt, Cairo, Egypt.', 'investigatorFullName': 'Sarah Elkot', 'investigatorAffiliation': 'Future University in Egypt'}}}}