Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-29 @ 1:14 PM
Study NCT ID:
NCT04470635
Status:
COMPLETED
Last Update Posted:
2024-01-30
First Post:
2020-07-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thiol/Disulphide Homeostasis and Vascular Endothelial Growth Factor Levels in Diabetic Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-29', 'studyFirstSubmitDate': '2020-07-10', 'studyFirstSubmitQcDate': '2020-07-10', 'lastUpdatePostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vascular endothelial growth factor level', 'timeFrame': 'Baseline', 'description': 'Vascular endothelial growth factor level in saliva'}], 'secondaryOutcomes': [{'measure': 'Thiol/disulphide measurement', 'timeFrame': 'Baseline', 'description': 'Total thiol, native thiol and disulphite level in saliva'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['type 1 diabetes mellitus'], 'conditions': ['Periodontal Diseases']}, 'descriptionModule': {'briefSummary': 'The aim of this study to evaluate the vascular endothelial growth factor level and thiol/disulphide homeostasis in saliva of diabetic children with gingivitis.', 'detailedDescription': 'Eighty children (44 with type 1 diabetes mellitus and 44 systemically healthy) will be recruited for the study. The children will be divided into four subgroups based on their periodontal and systemic condition: 1) systemically and periodontally healthy children, 2) systemically healthy children with gingivitis, 3) periodontally healthy children with T1DM, and 4) children with T1DM and gingivitis. The plaque index, gingival index, probing pocket depth, will recorded. The vascular endothelial growth factor level determined by ELISA. Native thiol, total thiol and disulphide levels will be measured in saliva.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '7 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Eigthy children will be recuited for the study . The children will be classified into four subgroups based on their periodontal status;\n\n1\\) systemically and periodontally healthy children, 2) systemically healthy children with gingivitis (G), 3) periodontally healthy children with T1DM, and 4) children with T1DM and gingivitis . The plaque index, gingival index and probing pocket depth will be recorded. The vascular endothelial growth factor in saliva will be determined by ELISA. Additionally total and native thiao and disulphide levels in saliva will be determined.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children diagnosed as type 1 diabetes mellitus\n* Age between 7-14 years\n\nExclusion Criteria:\n\n* Having another systemic problem except type 1 diabetes mellitus\n* Children carrying orthodontic appliances'}, 'identificationModule': {'nctId': 'NCT04470635', 'briefTitle': 'Thiol/Disulphide Homeostasis and Vascular Endothelial Growth Factor Levels in Diabetic Children', 'organization': {'class': 'OTHER', 'fullName': 'Aydin Adnan Menderes University'}, 'officialTitle': 'Thiol/Disulphide Homeostasis and Salivary Vascular Endothelial Growth Factor Levels in Type 1 Diabetic Patients With Gingivitis', 'orgStudyIdInfo': {'id': '2020/114'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Type 1 diabetes with gingivitis', 'description': 'Children with type 1 diabetes mellitus and gingivitis', 'interventionNames': ['Diagnostic Test: ELISA']}, {'label': 'Type 1 diabetes with healthy gingiva', 'description': 'Children with type 1 diabetes mellitus and healthy gingiva', 'interventionNames': ['Diagnostic Test: ELISA']}, {'label': 'Healthy children with gingivitis', 'description': 'Systemically healthy children with gingivitis', 'interventionNames': ['Diagnostic Test: ELISA']}, {'label': 'Healthy children and healthy gingiva', 'description': 'Systemically healthy children with healthy gingiva', 'interventionNames': ['Diagnostic Test: ELISA']}], 'interventions': [{'name': 'ELISA', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Thiol/disulphide measurement', 'Total thiol, native thiol and disulphide level'], 'description': 'Saliva sample collection', 'armGroupLabels': ['Healthy children and healthy gingiva', 'Healthy children with gingivitis', 'Type 1 diabetes with gingivitis', 'Type 1 diabetes with healthy gingiva']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aydin', 'country': 'Turkey (Türkiye)', 'facility': 'Sultan Keles', 'geoPoint': {'lat': 37.84501, 'lon': 27.83963}}], 'overallOfficials': [{'name': 'Sultan KELES, Assoc.Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aydin Adnan Menderes University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aydin Adnan Menderes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc.Prof.Dr', 'investigatorFullName': 'Sultan KELES', 'investigatorAffiliation': 'Aydin Adnan Menderes University'}}}}