Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 11:38 PM
Study NCT ID:
NCT07160894
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-08
First Post:
2025-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Nucleotide-Binding Oligomerization Domain-Containing Protein (NOD) 1 and NOD 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Saliva and serum of periodontitis patients collected for analyzing NOD1, NOD2, IL-10 and IL-6'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-07-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2025-08-29', 'studyFirstSubmitQcDate': '2025-08-29', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pocket probing depth', 'timeFrame': '6 months', 'description': 'Measurement of the depth of a sulcus or periodontal pocket determined by measuring distance from a gingival margin to the base of the sulcus or pocket with a calibrated periodontal probe.'}, {'measure': 'Clinical attachment level', 'timeFrame': '6 months', 'description': 'Clinical attachment level (or loss, CAL) is a more accurate indicator of the periodontal support around a tooth than probing depth alone. CAL is measured from a fixed point on the tooth that does not change, the CEJ.\n\nTo calculate CAL, two measurements are needed: distance from the gingival margin to the CEJ and probing depth.\n\nIn recession: probing depth (+) gingival margin to the CEJ (add). In tissue overgrowth: probing depth (-) gingival margin to the CEJ (subtract)'}, {'measure': 'Bleeding on probing', 'timeFrame': '6 months', 'description': 'Referring to bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus, or interface between the gingiva and a tooth.'}], 'secondaryOutcomes': [{'measure': 'Saliva and serum samples processing and analyses', 'timeFrame': '1 month', 'description': 'Saliva and serum samples obtained for each patient were used for cytokine analysis. Prepared samples were analyzed for NOD1, NOD2, IL-10 and IL-6 using commercial ELISA kits'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['periodontal disease NOD'], 'conditions': ['Periodontal Diseases Inflammation']}, 'descriptionModule': {'briefSummary': 'The host immune response to microorganisms is primarily recognized by pattern recognition receptors (PRRs), including toll-like receptors and nucleotide-binding oligomeric domain (NOD) receptors (NLRs). The aim of this study was to examine the relationship between periodontal disease and NOD in serum and saliva samples.', 'detailedDescription': 'Healthy participants (n:25), gingivitis (n:25) patients and stage III, grade B periodontitis (n:25) patients enrolled for this study. Clinical periodontal parameters and salivary flow rate were noted. Serum and saliva samples were collected to measure NOD1, NOD2, IL-10 and IL-6 levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* systemically healthy\n\n * clinical diagnosis of periodontal health\n * clinical diagnosis of periodontitis\n * clinical diagnosis of gingivitis\n\nExclusion Criteria:\n\n* • history of regular use of systemic antibiotics anti-inflammatory, or antioxidant drugs (previous 3 months)\n\n * nonsurgical periodontal treatment (previous 6 months)\n * surgical periodontal treatment (previous 12 months)\n * presence of\\<10 teeth\n * current medications affecting gingival health (calcium channel blockers, phenytoin, cyclosporine, and hormone replacement therapy)\n * diabetes\n * diagnosis of rheumatoid arthritis\n * pregnancy\n * lactating\n * smoking\n * excessive alcohol consumption.'}, 'identificationModule': {'nctId': 'NCT07160894', 'briefTitle': 'Evaluation of Nucleotide-Binding Oligomerization Domain-Containing Protein (NOD) 1 and NOD 2', 'organization': {'class': 'OTHER', 'fullName': 'Medipol University'}, 'officialTitle': 'Evaluation of Nucleotide-Binding Oligomerization Domain-Containing Protein (NOD) 1 and NOD 2 in Different Periodontal Conditions', 'orgStudyIdInfo': {'id': '672'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator', 'description': "Collection of patients' saliva and serum and analysis of sample molecules.", 'interventionNames': ['Other: Saliva and Serum sampling']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'ELISA method will be used to evaluate NOD1 and NOD2, IL-10, IL-6 molecules in the saliva and serum samples obtained.', 'interventionNames': ['Other: Saliva and Serum sampling']}], 'interventions': [{'name': 'Saliva and Serum sampling', 'type': 'OTHER', 'description': 'Saliva were collected to analyze the selected markers as unstimulated samples during the early hours of the day. The saliva was centrifuged and then transferred into Eppendorf tubes. Venous puncture was performed after saliva collection and 5 mL of blood samples were collected by qualified staff from each participant.Saliva and serum were then stored at -80 °C until analysis.', 'armGroupLabels': ['Active Comparator', 'Experimental']}, {'name': 'Saliva and Serum sampling', 'type': 'OTHER', 'description': 'ELISA method will be used to measure IL-10 and IL-6 values in collected saliva and serum samples. For ELISA analysis, a commercial kit (Sunred Bio, Shanghai, China) pre-coated with human selected antibodies will be used.', 'armGroupLabels': ['Active Comparator', 'Experimental']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Fatih', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Medipol University, School of Dentistry', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medipol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Prof Dr', 'investigatorFullName': 'Melis Yilmaz', 'investigatorAffiliation': 'Medipol University'}}}}