Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-25 @ 3:11 PM
Study NCT ID:
NCT03507868
Status:
COMPLETED
Last Update Posted:
2018-04-25
First Post:
2018-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
YKL-40 and IL-6 Levels in Periodontal Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010510', 'term': 'Periodontal Diseases'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Saliva and gingival crevicular fluid'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-16', 'studyFirstSubmitDate': '2018-04-16', 'studyFirstSubmitQcDate': '2018-04-16', 'lastUpdatePostDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'YKL-40 levels', 'timeFrame': 'at first and third month after therapy', 'description': 'changes in YKL-40 levels after periodontal therapy'}], 'secondaryOutcomes': [{'measure': 'IL-6 levels', 'timeFrame': 'at first and third month after therapy', 'description': 'changes in IL-6 levels after periodontal therapy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontal Diseases']}, 'descriptionModule': {'briefSummary': 'The primer aim of the study was to investigate saliva and gingival crevicular fluid (GCF) YKL-40 and also interleukin-6 (IL-6) levels in chronic periodontitis pathogenesis.', 'detailedDescription': 'This study consisted of two groups: 26 periodontally healthy individuals and 26 generalized chronic periodontitis patients. Chronic periodontitis patients were received nonsurgical periodontal treatment. Clinical measurements were recorded, saliva and GCF samples were obtained before and at first and third months after periodontal therapy. Levels of YKL-40 and IL-6 in saliva and GCF were analyzed by enzyme-linked immunosorbent assay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '26 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 52 participants', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGroup 1 Inclusion Criteria:\n\n* No bone and attachment loss,\n* GI=0, PPD≤3mm, CAL≤3mm\n* Systematically healthy patients\n\nGroup 2 Inclusion Criteria:\n\n* GI\\>1, PPD≥5mm, CAL≥5mm with alveolar bone loss radiographically.\n* Systematically healthy patients\n\nExclusion Criteria:\n\n* Aggressive Periodontitis,\n* Patients with any other systemic diseases,\n* Pregnant women and those in the lactation period,\n* Patients with smoking habit and taking medication\n* Patients received periodontal therapy in last 6 month'}, 'identificationModule': {'nctId': 'NCT03507868', 'briefTitle': 'YKL-40 and IL-6 Levels in Periodontal Disease', 'organization': {'class': 'OTHER', 'fullName': 'Aydin Adnan Menderes University'}, 'officialTitle': 'Effect of Non-Surgical Periodontal Therapy on Salivary and Gingival Crevicular Fluid YKL-40 and IL-6 Levels in Chronic Periodontitis', 'orgStudyIdInfo': {'id': '2016/1003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Periodontally healthy individuals'}, {'label': 'Group 2', 'description': 'Chronic periodontitis patients', 'interventionNames': ['Procedure: Nonsurgical periodontal therapy']}], 'interventions': [{'name': 'Nonsurgical periodontal therapy', 'type': 'PROCEDURE', 'description': 'Nonsurgical periodontal therapy includes oral hygiene education and scaling and root planning approaches to eliminate microbial dental plaque that is the primary etiology of periodontal diseases.', 'armGroupLabels': ['Group 2']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zeynep Pinar KELES', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'ZEYNEP PINAR KELEŞ', 'investigatorFullName': 'Zeynep Pinar KELES', 'investigatorAffiliation': 'Aydin Adnan Menderes University'}}}}