Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:36 PM
Study NCT ID:
NCT06354504
Status:
COMPLETED
Last Update Posted:
2024-04-09
First Post:
2024-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bactericidal Permeability Protein Inhibitor and Interleukin-1beta Levels After Non-surgical Periodontal Treatment
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2020-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-03', 'studyFirstSubmitDate': '2024-03-07', 'studyFirstSubmitQcDate': '2024-04-03', 'lastUpdatePostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gingival crevicular fluid Bactericidal/permeability-increasing proteins levels', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Gingival Crevicular Fluid Bactericidal Permeability Increasing Protein levels in periodonitis patients after Non-surgical periodontal treatment'}], 'secondaryOutcomes': [{'measure': 'Gingival crevicular fluid interleukin-1Beta levels', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Gingival Crevicular Fluid IL-1β in periodonitis patients after Non-surgical periodontal treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontitis']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to examine the relationship between healing response after non-surgical periodontal treatment and baseline gingival crevicular fluid (GCF) levels of bactericidal/permeability-increasing protein (BPI) and interleukin-1beta (IL-1ß).', 'detailedDescription': 'Bactericidal/permeability-increasing proteins (BPI) specific and powerful effect against Gram negative bacteria and their LPSs is completely observable in biological fluids such as plasma, serum, and whole blood.\n\nObjective: It is the evaluation of periodontal disease effect of BPI and interleukin-1 beta (IL-1 β) levels in gingival fluid before and after non-surgical periodontal treatment (NSPT)in patients with periodontal disease.\n\nMethod: Thirty systemically healthy and non-smoking individuals with periodontitis were included in the study. Before NSPT, the clinical parameters of plaque index (PI), gingival index (GI), probing depth (PD), clinical attachment level (CAS), bleeding on probing (BOP) were measured. The gingival fluid samples were taken using the paper strip method. The same procedures were repeated at 6 weeks and 6 months after non-surgical periodontal treatment. ELISA method was used for the analysis of the samples'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\nSystemically healthy,\n\n* Stage II or III, Grade A periodontitis\n* Having at least 20 permanent teeth (excluding third molars and any tooth loss induced by -non-periodontal causes).\n\nExclusion Criteria:\n\nSmoking,\n\n* use of alcohol; pregnancy or lactation; intake ofantibiotics, steroidal or non-steroidal anti-inflammatory drugs within the last 6 months\n* having received periodontal treatment within the last 6 months'}, 'identificationModule': {'nctId': 'NCT06354504', 'briefTitle': 'Bactericidal Permeability Protein Inhibitor and Interleukin-1beta Levels After Non-surgical Periodontal Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Akdeniz University'}, 'officialTitle': 'Gingival Crevicular Fluid (GCF) Bactericidal/Permeability-increasing Protein (BPI) and Interleukin (IL)-1beta in Periodontitis Patients: Non-surgical Periodontal Treatment Effects', 'orgStudyIdInfo': {'id': '20.02.2019/177'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healty', 'description': 'Non-surgical periodontal treatment', 'interventionNames': ['Procedure: Non-surgical periodontal treatment']}], 'interventions': [{'name': 'Non-surgical periodontal treatment', 'type': 'PROCEDURE', 'description': 'Scaling and root planing in two sessions over the course of a 48-hour period comprised the standard treatment procedure', 'armGroupLabels': ['Healty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07070', 'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'Akdeniz Üniversity', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}, {'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'Akdeniz Üniversitesi Diş Hekimliği Fakültesi', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akdeniz University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Nezahat Arzu Kayar', 'investigatorAffiliation': 'Akdeniz University'}}}}