Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-28 @ 12:14 AM
Study NCT ID:
NCT04053660
Status:
COMPLETED
Last Update Posted:
2019-08-12
First Post:
2019-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect Of Non-Surgical Periodontal Treatment On Lipoxin a4 Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-09', 'studyFirstSubmitDate': '2019-08-02', 'studyFirstSubmitQcDate': '2019-08-09', 'lastUpdatePostDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lipoxin A4 levels', 'timeFrame': '1st month', 'description': 'change of gingival crevicular fluid and salivary Lipoxin A4 levels from baseline at 1st month'}], 'secondaryOutcomes': [{'measure': 'Prostaglandin E2 levels', 'timeFrame': '1st month', 'description': 'change of gingival crevicular fluid and salivary Prostaglandin E2 levels from baseline at 1st month'}, {'measure': 'Leukotriene B4', 'timeFrame': '1st month', 'description': 'change of gingival crevicular fluid and salivary Leukotriene B4 levels from baseline at 1st month'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gingival Crevicular Fluid', 'Lipid Mediator', 'Periodontal Treatment'], 'conditions': ['Periodontitis']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate the levels of lipoxin A4 (LXA4), prostaglandin E2 (PGE2) and leukotriene B4 (LTB4) in gingival crevicular fluid (GCF) and saliva in individuals with periodontal healthy and chronic periodontitis. In addition, the investigators evaluated the levels of these mediators after non-surgical periodontal treatment in patients with chronic periodontitis. A total of 20 subjects, 10 patients with chronic periodontitis (CP) and 10 periodontally healthy individuals were included in the study. Clinical parameters including plaque index (PI), gingival index (GI), probing depth (PD) and clinical attachment levels (CAL) were recorded. GCF and saliva samples were obtained at the beginning of the study from all individuals. GCF and saliva samples were re-collected from patients with CP at 1 month after non surgical periodontal therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have at least 20 natural teeth, excluding third molars.\n* Chronic periodontitis patients had at least two non-adjacent sites per quadrant with probing depth (PD) ≥ 5 mm and clinical attachment level (CAL) ≥ 5 mm with gingival inflammation, and alveolar bone loss affecting \\>30% of the teeth, as detected on clinical and radiographical examinations.\n* Periodontally healthy control group had no sign of gingival inflammation, no PD \\> 3mm and no evidence of attachment or bone loss.\n\nExclusion Criteria:\n\n* History of systemic disease.\n* Regular use of any drugs which can effect the immune system or inflammatory response in the 6 months preceding the start of the study.\n* Periodontal treatment during last 6 months that could affect periodontal status.\n* Smoking.\n* History of radiotherapy or chemotherapy.\n* Ongoing orthodontic treatment.\n* Aggressive periodontitis.\n* Current pregnancy, lactation or menopause.'}, 'identificationModule': {'nctId': 'NCT04053660', 'briefTitle': 'Effect Of Non-Surgical Periodontal Treatment On Lipoxin a4 Levels', 'organization': {'class': 'OTHER', 'fullName': 'Ordu University'}, 'officialTitle': 'Effect Of Non-Surgical Periodontal Treatment On Endogenous Anti-Inflammatory Lipid Mediators In Patients With Chronic Periodontitis', 'orgStudyIdInfo': {'id': 'Ordu dental faculty'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Periodontally healthy group'}, {'type': 'EXPERIMENTAL', 'label': 'Chronic Periodontitis', 'description': 'Patients with chronic periodontitis', 'interventionNames': ['Procedure: Non-surgical periodontal treatment']}], 'interventions': [{'name': 'Non-surgical periodontal treatment', 'type': 'PROCEDURE', 'description': 'Mechanical non-surgical treatment were performed', 'armGroupLabels': ['Chronic Periodontitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52200', 'city': 'Ordu', 'country': 'Turkey (Türkiye)', 'facility': 'Ordu University', 'geoPoint': {'lat': 40.97782, 'lon': 37.89047}}], 'overallOfficials': [{'name': 'Ceren Gokmenoglu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ordu University Faculty of Dentistry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ordu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal invesitgator', 'investigatorFullName': 'Ceren Gökmenoğlu', 'investigatorAffiliation': 'Ordu University'}}}}