Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-30 @ 2:23 AM
Study NCT ID:
NCT04850768
Status:
UNKNOWN
Last Update Posted:
2021-04-20
First Post:
2021-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
(NOD)-Like Receptors CARD Domain-Containing 4 Levels in Individuals With Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D005891', 'term': 'Gingivitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva and gingival crevicular fluid'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-04-16', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-09-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-14', 'studyFirstSubmitDate': '2021-04-14', 'studyFirstSubmitQcDate': '2021-04-14', 'lastUpdatePostDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IL-1β levels', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'saliva and DOS levels'}, {'measure': 'IL-10 levels', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'saliva and DOS levels'}, {'measure': 'NLRC4', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'saliva and DOS levels'}], 'secondaryOutcomes': [{'measure': 'Plaque Index', 'timeFrame': 'up to 20 weeks', 'description': 'Silness-Löe'}, {'measure': 'Probing Depth', 'timeFrame': 'up to 20 weeks', 'description': 'millimeter'}, {'measure': 'Bleeding on Probe', 'timeFrame': 'up to 20 weeks', 'description': 'Ainamo\\&Bay'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NLRC4'], 'conditions': ['Periodontitis', 'Gingivitis', 'Healthy']}, 'descriptionModule': {'briefSummary': 'NLRC4, an inflammasome , is a cytosolic multiprotein complex involved in the initiation and modulation of the immune response. Periodontitis is a chronic inflammatory disease that can start with localized inflammatory reactions created by the supporting tissues surrounding the teeth against microorganisms and then result in loss of teeth. It has been said that proinflammatory cytokines released in the microenvironment of periodontitis can increase the expression of NLRC4 inflammasome genes. The authors think that NLRC4 may play a role in the periodontitis. The aim of this study is to compare the NLRC4, IL-1β and IL-10 levels of healthy and periodontitis individuals.', 'detailedDescription': 'Periodontitis is a destructive chronic inflammatory disease that can start with localized inflammatory reactions created by the supporting tissues surrounding the teeth against microorganisms and then result in loss of teeth. Inflammasomes are cytosolic multiprotein complex involved in the initiation and modulation of the immune response.\n\nInterleukine -1β ( IL-1β ) levels are associated with periodontal destruction in the pathogenesis of periodontal disease. Interleukine-10 (IL-10) has been reported to decrease periodontal disease progression rate.\n\nGingival crevicular fluid shows the cellular response in the periodontium. The most important host-related ingredients are inflammatory markers, including cytokines, enzymes, and interleukins. Saliva analysis is used in the diagnosis of systemic conditions as well as in the diagnosis of oral pathologies.\n\nBoth NLRC4 and NLRP3 inflammasomes have been shown to play an important role in the induction of interleukin-1β secretion. Periodontitis is induced by a complex microbial biofilm containing multiple Gram-positive and Gram-negative bacteria (including flagellate microorganisms) capable of activating a large number of NLRs. It has been said that proinflammatory cytokines released in the microenvironment of periodontitis can increase the expression of NLRC4 inflammasome genes. Evidence on the role of inflammasomes in periodontal disease is still very poor. The aim of this study is to compare the NLRC4, IL-1β and IL-10 levels of healthy and periodontitis individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals will be divided into three different groups, about 20-25 people in each group.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* systemically healthy individuals who does not have a disease under treatment, individuals without regular systemic medication\n\nExclusion Criteria:\n\n* smoking receiving periodontal treatment in the last 6 months pregnancy menopausal or menstrual period'}, 'identificationModule': {'nctId': 'NCT04850768', 'briefTitle': '(NOD)-Like Receptors CARD Domain-Containing 4 Levels in Individuals With Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi'}, 'officialTitle': 'Evaluation of (NOD)-Like Receptors CARD Domain-containing 4 Levels in Individuals With Healthy and Periodontal Disease', 'orgStudyIdInfo': {'id': '21-29'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Periodontitis', 'description': 'Individuals with Periodontitis', 'interventionNames': ['Other: Saliva', 'Other: gingival crevicular fluid']}, {'label': 'Gingivitis', 'description': 'Individuals with Gingival Inflammation', 'interventionNames': ['Other: Saliva', 'Other: gingival crevicular fluid']}, {'label': 'Healthy', 'description': 'Individuals with Periodontally Healthy', 'interventionNames': ['Other: Saliva', 'Other: gingival crevicular fluid']}], 'interventions': [{'name': 'Saliva', 'type': 'OTHER', 'otherNames': ['sampling'], 'description': "individuals' saliva samples will be collected and transferred to eppendorf tubes.\n\nUntil biochemical analysis is carried out will be stored in -80ºC.", 'armGroupLabels': ['Gingivitis', 'Healthy', 'Periodontitis']}, {'name': 'gingival crevicular fluid', 'type': 'OTHER', 'otherNames': ['sampling'], 'description': 'GCF samples of individuals will be collected by paper strips and transferred to eppendorf tubes.Until biochemical analysis is carried out will be stored in -80ºC.', 'armGroupLabels': ['Gingivitis', 'Healthy', 'Periodontitis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Saglik Bilimleri Universitesi', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Ayşe Toraman, Dr', 'role': 'CONTACT', 'email': 'draysetoraman@gmail.com', 'phone': '05385025422'}], 'overallOfficials': [{'name': 'Ayşe Toraman, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saglik Bilimleri Universitesi'}, {'name': 'Ebru Sağlam, Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'Saglik Bilimleri Universitesi'}, {'name': 'Serhat Köseoğlu, assoc prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Saglik Bilimleri Universitesi'}, {'name': 'Mehmet Sağlam, assoc prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Izmir Katip Celebi University'}, {'name': 'Levent Savran, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Izmir Katip Celebi University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Ayse Toraman', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi'}}}}