Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2026-02-21 @ 5:56 AM
Study NCT ID:
NCT02433405
Status:
COMPLETED
Last Update Posted:
2015-05-05
First Post:
2015-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum Amyloid A Protein And Fetuin A Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010510', 'term': 'Periodontal Diseases'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D060749', 'term': 'alpha-2-HS-Glycoprotein'}, {'id': 'D000685', 'term': 'Serum Amyloid A Protein'}], 'ancestors': [{'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D060748', 'term': 'Fetuins'}, {'id': 'D000510', 'term': 'Alpha-Globulins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D002135', 'term': 'Calcium-Binding Proteins'}, {'id': 'D002352', 'term': 'Carrier Proteins'}, {'id': 'D015891', 'term': 'Cystatins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D058227', 'term': 'Amyloidogenic Proteins'}, {'id': 'D000682', 'term': 'Amyloid'}, {'id': 'D000209', 'term': 'Acute-Phase Proteins'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Gingival crevicular fluid and Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-29', 'studyFirstSubmitDate': '2015-04-24', 'studyFirstSubmitQcDate': '2015-04-29', 'lastUpdatePostDateStruct': {'date': '2015-05-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Amyloid A (SAA) levels as an inflammatory marker in periodontal disease both in serum and GCF', 'timeFrame': 'Day 0'}], 'secondaryOutcomes': [{'measure': 'Fetuin-A levels as an inflammatory marker in periodontal disease both in serum and GCF', 'timeFrame': 'Day 0'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Serum Amyloid A', 'Fetuin-A', 'gingival crevicular fluid', 'serum', 'periodontal diseases'], 'conditions': ['Periodontal Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate acute phase proteins (APPs) Fetuin-A and Serum Amyloid A (SAA) levels in gingival crevicular fluid (GCF) and serum samples in periodontal health and disease.', 'detailedDescription': "The study population consisted totally 60 subjects consulted to Bulent Ecevit University, Faculty of Dentistry, Department of Periodontology whose age and sex were matched.\n\nAccording to study design, subjects were divided into three groups based on their periodontal parameters. Patients suffering from chronic periodontitis formed the group 1 (n: 20), patients with plaque induced gingivitis formed the group 2 (n:20) and periodontal healthy patients were inserted in group 3 (n:20).\n\nAfter gently drying the area, GCF was sampled with filter paper using the intracrevicular method (Periopaper, ProFlow, Inc., Amityville, New York, USA).Two milliliters (ml) of peripheral blood was collected from each individual with sterile syringe from the antecubital fossa by venipuncture, and to separate serum component sample centrifuged at 3000g for 5 min, and immediately stored at -40°C until assayed.\n\nThe quantity of Fetuin-A and SAA protein concentration in the samples were analyzed by sandwich enzyme-linked immunosorbent assay (ELISA) procedures using commercially available kits.\n\nThe Spearman's rank correlation test was used to detect the relationship between GCF and serum SAA and Fetuin-A with GI and CAL. All tests were performed using statistical software (SPSS Inc., version 22.0, Chicago, IL, USA). The mean ± standard deviation with mean rank values were calculated for each parameter, based on the patients as the statistical unit. P \\< 0.05 was considered to be statistically significant."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '28 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consisted totally 60 subjects whose age (28-45) and sex (33 men, 27 female) were matched.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Group 1 Inclusion Criteria:\n\n* GI\\>1, PPD≥5mm, CAL≥5mm with alveolar bone loss radiographically.\n* Systematically healthy patients\n\nGroup 2 Inclusion Criteria:\n\n* No alveolar bone and attachment loss\n* Inflammation signs such as redness, edema and increased BOP levels,\n* GI≥2, PPD≤3mm, CAL≤3mm.\n* Systematically healthy patients\n\nGroup 3 Inclusion Criteria:\n\n* No bone and attachment loss,\n* GI=0, PPD≤3mm, CAL≤3mm\n* Systematically healthy patients\n\nExclusion Criteria for all groups:\n\n* Aggressive Periodontitis,\n* Oral pathologies,\n* Patients with any other systemic diseases,\n* Pregnant women and those in the lactation period,\n* Patients with smoking habit and taking medication\n* Patients received periodontal therapy in last 6 months'}, 'identificationModule': {'nctId': 'NCT02433405', 'briefTitle': 'Serum Amyloid A Protein And Fetuin A Levels', 'organization': {'class': 'OTHER', 'fullName': 'Bulent Ecevit University'}, 'officialTitle': 'Serum Amyloid A Protein And Fetuin A Protein Levels In Periodontal Health And Disease', 'orgStudyIdInfo': {'id': 'SAAFA1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Chronic Periodontitis-serum amyloid A, Fetuin-A', 'interventionNames': ['Biological: Fetuin-A', 'Biological: Serum Amyloid A']}, {'label': 'Group 2', 'description': 'Plaque induced Gingivitis-serum amyloid A, Fetuin-A', 'interventionNames': ['Biological: Fetuin-A', 'Biological: Serum Amyloid A']}, {'label': 'Group 3', 'description': 'Control Group-serum amyloid A, Fetuin-A', 'interventionNames': ['Biological: Fetuin-A', 'Biological: Serum Amyloid A']}], 'interventions': [{'name': 'Fetuin-A', 'type': 'BIOLOGICAL', 'description': 'Acute phase protein', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}, {'name': 'Serum Amyloid A', 'type': 'BIOLOGICAL', 'description': 'Acute phase protein', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'ÇİĞDEM COŞKUN TÜRER, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BULENT ECEVIT UNIVERSITY FACULTY OF DENTISTRY DEPARTMENT OF PERIODONTOLOGY'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bulent Ecevit University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'ÇİĞDEM COŞKUN TÜRER', 'investigatorAffiliation': 'Bulent Ecevit University'}}}}