Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-31 @ 8:16 PM
Study NCT ID:
NCT06879951
Status:
COMPLETED
Last Update Posted:
2025-03-17
First Post:
2025-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EVALUATION of GINGIVAL CREVICULAR FLUID and SERUM ASPROSIN LEVELS in OBESE and NORMAL-WEIGHT INDIVIDUALS with PERIODONTITIS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D054119', 'term': 'Arachnodactyly'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017880', 'term': 'Limb Deformities, Congenital'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2025-03-11', 'studyFirstSubmitQcDate': '2025-03-11', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biyomarker levels', 'timeFrame': '08.10.2023-08.10.2024', 'description': "All groups' GCF and serum levels of asprosin, TNF-α, and IL-6 levels"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Periodontitis', 'Obesity', 'Asprosin', 'Chronic Inflammatory Diseases'], 'conditions': ['Periodontitis', 'Obesity']}, 'descriptionModule': {'briefSummary': 'Obesity and periodontitis are chronic inflammatory diseases that share common pathological mechanisms. Asprosin, a novel adipokine discovered in 2016, has not been extensively studied in relation to periodontal tissues. In our study, we investigate the levels of asprosin in both serum and gingival crevicular fluid of patients with obesity and those of normal weight who have periodontitis. Additionally, our research aims to clarify the pathophysiological mechanisms linking periodontitis and obesity by examining local and systemic levels of TNF-α, IL-6, and asprosin, alongside clinical periodontal parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients were recruited from the Periodontology Clinic at Gazi University Faculty of Dentistry between August 2023 and August 2024. All participants who met the inclusion criteria were included in the study. Before their participation, the study's purpose and methods were explained, and written informed consent was obtained.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Willingness to participate in the study.\n2. Weight classification:\n\n * Obese individuals: Body mass index (BMI) of 30 kg/m² or higher.\n * Normal-weight individuals: BMI between 18.5 and 24.9 kg/m².\n3. Periodontal health status:\n\n * Bleeding on probing: less than 10%.\n * Periodontal pocket depth: less than 3 mm.\n * No sites showing attachment loss or alveolar bone loss on radiographs.\n4. For individuals with periodontitis:\n\n * At least two non-adjacent teeth must show signs of interdental attachment loss.\n * Periodontal pocket depth greater than 3 mm.\n\nExclusion Criteria:\n\n1. Individuals who have received periodontal therapy, any oral decontamination treatment, or antibiotics or steroids in the six months prior to the start of the study.\n2. Individuals who are pregnant or breastfeeding.\n3. Individuals diagnosed with rheumatoid arthritis or lupus erythematosus.\n4. Individuals with a medical history of radiation or cancer therapy.\n5. Patients with diabetes, defined by:\n\n * Hemoglobin A1c (HbA1c) level greater than 6.5%.\n * Fasting blood glucose (FBG) greater than 126 mg/dL.\n * An abnormal oral glucose tolerance test (OGTT).\n6. Smokers.'}, 'identificationModule': {'nctId': 'NCT06879951', 'briefTitle': 'EVALUATION of GINGIVAL CREVICULAR FLUID and SERUM ASPROSIN LEVELS in OBESE and NORMAL-WEIGHT INDIVIDUALS with PERIODONTITIS', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'Evaluation of Serum and Gingival Crevicular Fluid Asprosin Levels in Obese and Normal-Weight Patients with Periodontitis', 'orgStudyIdInfo': {'id': 'E-21071282-050.99-720599'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obese individiuals with periodontitis', 'interventionNames': ['Other: Participants are not assigned an intervention as part of the study.']}, {'label': 'Obese individuals with periodontal healthy', 'interventionNames': ['Other: Participants are not assigned an intervention as part of the study.']}, {'label': 'Normal-weight Individuals with Periodontitis', 'interventionNames': ['Other: Participants are not assigned an intervention as part of the study.']}, {'label': 'Normal-weight Individuals with periodontal health', 'interventionNames': ['Other: Participants are not assigned an intervention as part of the study.']}], 'interventions': [{'name': 'Participants are not assigned an intervention as part of the study.', 'type': 'OTHER', 'description': 'Participants are not assigned an intervention as part of the study.', 'armGroupLabels': ['Normal-weight Individuals with Periodontitis', 'Normal-weight Individuals with periodontal health', 'Obese individiuals with periodontitis', 'Obese individuals with periodontal healthy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06490', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi University Faculty of Dentistry', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Aysen Bodur, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gazi University Faculty of Dentistry Department of Periodontology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gazi University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gazi University Scientific Research Unit', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research assistant', 'investigatorFullName': 'Buse Naz BÜYÜKAKÇALI ALTAY', 'investigatorAffiliation': 'Gazi University'}}}}