Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-28 @ 10:56 PM
Study NCT ID:
NCT06427902
Status:
COMPLETED
Last Update Posted:
2024-05-24
First Post:
2024-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inflammatory Biomarkers in Saliva at Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005891', 'term': 'Gingivitis'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Saliva'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-22', 'studyFirstSubmitDate': '2024-05-16', 'studyFirstSubmitQcDate': '2024-05-22', 'lastUpdatePostDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SalivaryTREM-1', 'timeFrame': '06-09 2019', 'description': 'Both, soluble and membrane-bound TREM-1, are detected by the TREM-1 ELISA.'}, {'measure': 'Salivary PGLYRP1', 'timeFrame': '06-09 2019', 'description': 'Both, soluble and membrane-bound PGLYRP1 are detected by the PGLYRP1 ELISA.'}, {'measure': 'Salivary IL-1β', 'timeFrame': '06-09 2019', 'description': 'Both, soluble and membrane-bound IL-1β detected by the IL-1β ELISA.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingivitis', 'Depression', 'Inflammation', 'Inflammatory Response']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to evaluate the inflammatory saliva biomarkers in depression and gingivitis.\n\nThe main question will be ; Will there be an increase at salivary biomarkers with depression patients and is it associated with gingivitis?', 'detailedDescription': 'Background: The neuroimmune regulation disorder in depression patients causes the progression of inflammatory periodontal disease. The present study was to evaluate the periodontal health status and the levels of Triggering receptor expressed on myeloid cells 1 (TREM-1), peptidoglycan recognition protein 1 (PGLYRP1) and interleukin-1 beta (IL-1β) in individuals diagnosed with depression and to compare these findings with those of systemically healthy individuals.\n\nMethods: Forty-two depression patients were classified in two groups: depression with gingivitis (DG) and depression with periodontally healthy (DPH) patients. Additionally, 23 systemically and periodontally healthy (SPH) individuals were enrolled to the study. Periodontal parameters were recorded. Saliva samples were collected and salivary levels of TREM-1, PGLYRP1, IL-1β were measured using Enzyme-linked Immunosorbent Assay (ELISA) kits.\n\ndepression regardless of periodontal status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '53 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study was carried out on 65 participants in total, including 42 individuals who applied to Aydın State Hospital Psychiatry Outpatient Clinic, diagnosed with depressive disorder, were classified in 2 different groups; depression with gingivitis (DG), depression with periodontally healthy (DPH) patients and 23 systemically and periodontally healthy (SPH) individuals who applied to Adnan Menderes University Faculty of Dentistry.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who were moderate in severity according to the test result, who had not started drug therapy yet and who had not received antidepressant medication in the last 12 months\n\nExclusion Criteria: Patients with\n\n* psychotic disorders\n* autism spectrum disorders\n* other anxiety disorders\n* bipolar disorder\n* mental any organic mental disorder and\n* smokers, substance users'}, 'identificationModule': {'nctId': 'NCT06427902', 'briefTitle': 'Inflammatory Biomarkers in Saliva at Depression', 'organization': {'class': 'OTHER', 'fullName': 'Medipol University'}, 'officialTitle': 'Salivary Biomarkers of Gingival Inflammation Are Associated With Depression', 'orgStudyIdInfo': {'id': 'Depression'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'depression with gingivitis (DG) group', 'description': 'The diagnosis of depressive disorder was established using the Structured Clinical Interviews for Axis I Disorders (SCID) criteria of the Diagnostic and Statistical Manual of Mental Disorders.\n\nthe gingivitis group was determined by the criteria of pocket depth of 3 mm or less.', 'interventionNames': ['Other: Periodontal clinical measurements, Saliva sampling']}, {'label': 'depression with periodontally healthy (DPH) patients', 'description': 'The diagnosis of depressive disorder was established using the Structured Clinical Interviews for Axis I Disorders (SCID) criteria of the Diagnostic and Statistical Manual of Mental Disorders.', 'interventionNames': ['Other: Periodontal clinical measurements, Saliva sampling']}, {'label': 'systemically and periodontally healthy (SPH) individuals', 'description': 'This group contists of individuals who are systemically and periodontally healthy', 'interventionNames': ['Other: Periodontal clinical measurements, Saliva sampling']}], 'interventions': [{'name': 'Periodontal clinical measurements, Saliva sampling', 'type': 'OTHER', 'description': 'Clinical periodontal indices; Probing depth, Clinical attachment level, bleeding on probing, gingival index, and plaque', 'armGroupLabels': ['depression with gingivitis (DG) group', 'depression with periodontally healthy (DPH) patients', 'systemically and periodontally healthy (SPH) individuals']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34365', 'city': 'Istanbul', 'state': 'Select State', 'country': 'Turkey (Türkiye)', 'facility': 'Duygu Ilhan', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medipol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asst. Prof', 'investigatorFullName': 'DUYGU ILHAN', 'investigatorAffiliation': 'Medipol University'}}}}