Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-02-21 @ 1:02 PM
Study NCT ID:
NCT02750956
Status:
COMPLETED
Last Update Posted:
2016-04-26
First Post:
2016-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endocan, VEGF and TNF-alpha Levels in Periodontal Disease and After Treatment
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': 'Gingival crevicular fluid and Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-21', 'studyFirstSubmitDate': '2016-04-19', 'studyFirstSubmitQcDate': '2016-04-21', 'lastUpdatePostDateStruct': {'date': '2016-04-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endocan levels', 'timeFrame': '6 weeks', 'description': 'Change after periodontal treatment'}], 'secondaryOutcomes': [{'measure': 'VEGF levels', 'timeFrame': '6 weeks', 'description': 'Change after periodontal treatment'}, {'measure': 'TNF-alpha levels', 'timeFrame': '6 weeks', 'description': 'Change after periodontal treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['endocan protein', 'VEGF A', 'TNF-alpha', 'after treatment'], 'conditions': ['Periodontal Disease']}, 'descriptionModule': {'briefSummary': 'The primer aim of the study was to determine serum and gingival crevicular fluid (GCF) endocan levels in periodontal diseases pathogenesis supported with vascular endothelial growth factor (VEGF) and tumor necrosis factor alpha (TNF-α) levels.', 'detailedDescription': 'The study consist of three groups: periodontally healthy individuals (group 1; n = 20), individuals with generalized chronic periodontitis (group 2; n = 20), the same patients with chronic periodontitis after they had been treated with scaling and root planing (SRP) were considered as Group 3. Clinical measurements were recorded; GCF and serum samples were obtained from each participant before and 6 weeks after therapy. Endocan, VEGF-A and TNF-α levels were measured by enzyme-linked immunosorbent assay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '25 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Total of 40 individuals', 'healthyVolunteers': True, 'eligibilityCriteria': 'Group 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* Oral pathologies,\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 months'}, 'identificationModule': {'nctId': 'NCT02750956', 'briefTitle': 'Endocan, VEGF and TNF-alpha Levels in Periodontal Disease and After Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Bulent Ecevit University'}, 'officialTitle': 'Effect of Non-surgical Periodontal Treatment on Gingival Crevicular Fluid and Serum Endocan, Vascular Endothelial Growth Factor-A and Tumor Necrosis Factor Alpha Levels', 'orgStudyIdInfo': {'id': 'Endocan'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Periodontal healthy individuals'}, {'label': 'Group 2', 'description': 'Patients with chronic periodontitis', 'interventionNames': ['Procedure: Non-surgical periodontal treatment']}, {'label': 'Group 3', 'description': 'the same patients in group 2 after they had been treated with scaling and root planing (SRP) were considered as Group 3.', 'interventionNames': ['Procedure: Non-surgical periodontal treatment']}], 'interventions': [{'name': 'Non-surgical periodontal treatment', 'type': 'PROCEDURE', 'description': 'Non-surgical periodontal therapy is an anti-infective therapy which includes both mechanical and chemotherapeutic approaches to minimize or eliminate microbial biofilm, the primary etiology of gingivitis and periodontitis', 'armGroupLabels': ['Group 2', 'Group 3']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'ÇİĞDEM COŞKUN TÜRER', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BULENT ECEVIT UNIVERSITY FACULTY OF DENTISTRY DEPARTMENT OF PERIODONTOLOGY'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bulent Ecevit University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'ÇİĞDEM COŞKUN TÜRER', 'investigatorAffiliation': 'Bulent Ecevit University'}}}}