Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2025-12-26 @ 3:06 AM
Study NCT ID:
NCT03442920
Status:
COMPLETED
Last Update Posted:
2018-02-22
First Post:
2018-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Periodontal Diseases and Obesity in Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2016-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-21', 'studyFirstSubmitDate': '2018-02-09', 'studyFirstSubmitQcDate': '2018-02-21', 'lastUpdatePostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biochemical variables GCF', 'timeFrame': '12 week', 'description': 'TNF-A, IL-1B,concentrations levels (pg/µl)'}, {'measure': 'Biochemical variables GCF', 'timeFrame': '12 week', 'description': 'Leptin, adiponectin, resistin concentrations levels (ng/µl)'}], 'secondaryOutcomes': [{'measure': 'Biochemical variables_Saliva', 'timeFrame': '12 week', 'description': 'TNF-A, IL-1B,concentrations levels (pg/µl)'}, {'measure': 'Biochemical variables_Saliva', 'timeFrame': '12 week', 'description': 'leptin, adiponectin, resistin concentrations levels (ng/µl)'}, {'measure': 'Biochemical variables_Serum', 'timeFrame': '12 week', 'description': 'TNF-A, IL-1B,concentrations levels (pg/µl)'}, {'measure': 'Biochemical variables_Serum', 'timeFrame': '12 week', 'description': 'leptin, adiponectin, resistin concentrations levels (ng/µl)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obesity', 'periodontal diseases', 'gingival crevicular fluid', 'saliva', 'serum'], 'conditions': ['Periodontal Diseases', 'Obesity']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate the effect of obesity and exercise on periodontal and biochemical parameters \\[serum, saliva and gingival crevicular fluid (GCF) adipokines (interleukin-1β, tumor necrosis factor-α, leptin, resistin and adiponectin)\\].', 'detailedDescription': 'It is thought that adipokines may play a role on periodontal disease in obese subjects, periodontal disease may also aggravate the existing systemic disease by changing the inflammatory parameters in the body. The aim of this study was to evaluate the effect of obesity and exercise on periodontal and biochemical parameters \\[serum, saliva and gingival crevicular fluid (GCF) adipokines (interleukin-1β, tumor necrosis factor-α, leptin, resistin and adiponectin)\\].'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'genderDescription': 'adult women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being women,\n* Older than 18 yrs old,\n* Not being pregnant,\n* Not being disabled,\n* For study group; being obese, not for healthy group being systemically health and in normal weight\n* Not treated periodontological in the last 6 months\n\nExclusion Criteria:\n\n* Younger than 18 yrs old,\n* Smokers who smokes more than 10 cigarettes in a day,\n* Uncontrolled systemic diseases,\n* Having periodontal treatment\n* who needs antibiotic prophylaxis'}, 'identificationModule': {'nctId': 'NCT03442920', 'briefTitle': 'Evaluation of Periodontal Diseases and Obesity in Women', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'The Effects of Obesity and Periodontitis on Biochemical Parameters in Women Subjects', 'orgStudyIdInfo': {'id': '114S144'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Obese women', 'description': 'Obese women who participated exercise programme.', 'interventionNames': ['Other: Exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Normal weighted', 'description': 'Normal weighted women with non-periodontitis'}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'This group made exercise for 12 week/3 times a week.', 'armGroupLabels': ['Obese women']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41190', 'city': 'Kocaeli', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli University', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Scientific and Technological Research Council of Turkey', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Esra Guzeldemir-Akcakanat', 'investigatorAffiliation': 'Kocaeli University'}}}}