Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2026-01-09 @ 8:39 PM
Study NCT ID:
NCT04655859
Status:
COMPLETED
Last Update Posted:
2020-12-07
First Post:
2020-11-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thiol/Disulfide and Oxidative Stress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-30', 'studyFirstSubmitDate': '2020-11-30', 'studyFirstSubmitQcDate': '2020-11-30', 'lastUpdatePostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'thiol/disulfide homeostasis', 'timeFrame': 'six months', 'description': 'Unstimulated saliva samples were taken from all children. Then, thiol/disulfide homeostasis and antioxidant levels were evaluated.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Severe Early Childhood Caries']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate the role of thiol/disulfide homeostasis and oxidative stress in the saliva of children with severe early childhood caries'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '3 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'the children with severe early childhood caries which are 3-5 years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 3-5 years\n\nExclusion Criteria:\n\n* the children with systemic illness, using anti-inflammatory drug'}, 'identificationModule': {'nctId': 'NCT04655859', 'briefTitle': 'Thiol/Disulfide and Oxidative Stress', 'organization': {'class': 'OTHER', 'fullName': 'Kahramanmaras Sutcu Imam University'}, 'officialTitle': 'Evaluation of Saliva Thiol/Disulfide Homeostasis and Oxidative Stress in Children With Severe Early Childhood Caries by a Novel Method- Part 1', 'orgStudyIdInfo': {'id': '2020/1-19M'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'severe early childhood caries', 'interventionNames': ['Diagnostic Test: saliva cotton swab']}, {'label': 'healthy children', 'interventionNames': ['Diagnostic Test: saliva cotton swab']}], 'interventions': [{'name': 'saliva cotton swab', 'type': 'DIAGNOSTIC_TEST', 'description': 'evaluate the role of thiol/disulfide homeostasis and oxidative stress in the saliva of children with severe early childhood caries and healthy group', 'armGroupLabels': ['healthy children', 'severe early childhood caries']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kahramanmaraş', 'country': 'Turkey (Türkiye)', 'facility': 'Aslı Soğukpınar', 'geoPoint': {'lat': 37.5847, 'lon': 36.92641}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The thiol/disulfide homeostasis and antioxidant levels is to be shared in this study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kahramanmaras Sutcu Imam University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Aslı Sogukpınar', 'investigatorAffiliation': 'Kahramanmaras Sutcu Imam University'}}}}