Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-02-25 @ 5:13 AM
Study NCT ID:
NCT02954120
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2016-10-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Periodontitis and Polycystic Ovary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D055113', 'term': 'Chronic Periodontitis'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum and saliva samples were obtained and stored until biochemical analyses'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-13', 'studyFirstSubmitDate': '2016-10-28', 'studyFirstSubmitQcDate': '2016-11-01', 'lastUpdatePostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '8-OHdG levels (nanogram per mililiter(ng/mL))', 'timeFrame': 'appoximately 2 years', 'description': 'by ELISA test'}, {'measure': 'MDA levels (micromole per liter (µmol/L))', 'timeFrame': 'appoximately 2 years', 'description': 'by ELISA test'}, {'measure': 'TAS levels (millimolar per liter (mmol /L))', 'timeFrame': 'appoximately 2 years', 'description': 'by ELISA test'}, {'measure': 'Plaque Index (PI)', 'timeFrame': 'appoximately 2 years', 'description': 'Silnes-Löe Periodondal İndex'}, {'measure': 'Gingival Index (GI)', 'timeFrame': 'appoximately 2 years', 'description': 'Löe-Silness Periodontal Index'}, {'measure': 'Bleeding on probing (BOP)', 'timeFrame': 'appoximately 2 years', 'description': 'Gİngival Bleeding Index'}, {'measure': 'Clinical attachment level (CAL)', 'timeFrame': 'Patients were seen one time', 'description': 'by measuring the distance between the cementoenamel junction and the periodontal pocket base'}, {'measure': 'Probing pocket depth (PD))', 'timeFrame': 'appoximately 2 years', 'description': 'distance between free gingival margin and periodontal pocket base by usin periodontal probe'}], 'secondaryOutcomes': [{'measure': 'number of individuals with chronic periodontitis', 'timeFrame': 'appoximately 2 years', 'description': 'individuals in the group'}, {'measure': 'numberer of individuals with polycystic ovary syndrome', 'timeFrame': 'appoximately 2 years', 'description': 'individuals in the group'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['8- hydroxy -2´- deoxyguanosine', 'Malondialdehyde', 'Total antioxidant status', 'Oxidative stres'], 'conditions': ['Polycystic Ovary Syndrome', 'Chronic Periodontitis']}, 'descriptionModule': {'briefSummary': 'Background: The aim of this study was to investigate the levels of malondialdehyde (MDA), total antioxidant status (TAS), 8-hydroxy-2´- deoxyguanosine (8-OHdG) in blood serum and saliva samples in female patients with chronic periodontitis (CP) and to compared healthy individuals.\n\nMaterials and Methods: A total of 88 women were into four groups each which were consisted of twenty-two subjects. Groups were designed as periodontally and systemically healthy women (PCOS-CP-); periodontally healthy women with polycystic ovary syndrome (PCOS) (PCOS+CP-), systemically healthy women with CP (PCOS-,CP+) and women with PCOS and CP (PCOS+CP+). Serum and salivary samples were obtained, clinical periodontal parameters were recorded. MDA, TAS, 8-OHdG levels were measured as biochemically.', 'detailedDescription': 'RESULTS:\n\nSalivary 8-OHdG levels in the PCOSCP and CP groups were statistically higher than those in both the PCOSPH and the PH groups (P \\< 0.05). There was no statistical difference between the PCOSCP, CP, and PCOSPH groups with regard to salivary MDA and TAS levels (P \\> 0.05). Highest serum 8-OHdG and MDA levels and lowest serum TAS levels were seen in the PCOSCP group (P \\< 0.05). Serum 8-OHdG and MDA levels in the PCOSPH group were higher than those in both systemically healthy groups (PH and CP) (P \\< 0.05). Salivary TAS levels were highest (P \\< 0.05) in the PH group. There was no statistical difference between the CP and PCOSPH groups, but serum TAS levels were lower than those in the PH group (P \\< 0.05).\n\nCONCLUSIONS:\n\nCP, which led to an increase in serum and salivary 8-OHdG and MDA levels and a decrease in serum TAS levels in patients with PCOS, contributed to increased OS. This effect was more prominent in serum levels than in salivary levels.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All participants were recruited among women at the Department of Obstetrics and Gynecology, School of Medicine, Ataturk University', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed non-obese PCOS patients\n* Never smokers\n* Had no history of systemic disease\n* BMI\\<25 kg/m2\n* Participants had ≥20 teeth present.\n\nExclusion Criteria:\n\n* Pregnancy\n* Lactation\n* Hemoglobin A1c (HbA1c) ≥ 6.5%\n* 2-h oral glucose tolerance test (OGTT-2h) ≥200\n* Cushing syndrome, non-classic congenital adrenal hyperplasia, hyperprolactinemia, thyroid dysfunction, and androgen-secreting tumors\n* Any drug use within the past 6 months\n* Periodontal treatment within the past 6 months'}, 'identificationModule': {'nctId': 'NCT02954120', 'briefTitle': 'Chronic Periodontitis and Polycystic Ovary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': 'Evaluation Of Lipid Peroxidation, Oxidative DNA Damage And Total Antioxidant Status In Patients With Periodontitis And Polycystic Ovary Syndrome: A Cross Sectional Study', 'orgStudyIdInfo': {'id': 'PCOSandCP'}}, 'armsInterventionsModule': {'armGroups': [{'label': '(PCOS-CP-)', 'description': 'systemically and periodontally healthy participants', 'interventionNames': ['Other: no intervention provided']}, {'label': '(PCOS-CP+)', 'description': 'systemically healthy participants with CP', 'interventionNames': ['Other: no intervention provided']}, {'label': '(PCOS+CP-)', 'description': 'PCOS participants with periodontally healthy', 'interventionNames': ['Other: no intervention provided']}, {'label': '(PCOS+CP+)', 'description': 'PCOS participants with CP', 'interventionNames': ['Other: no intervention provided']}], 'interventions': [{'name': 'no intervention provided', 'type': 'OTHER', 'armGroupLabels': ['(PCOS+CP+)', '(PCOS+CP-)', '(PCOS-CP+)', '(PCOS-CP-)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34093', 'city': 'Istanbul', 'state': 'Fatih', 'country': 'Turkey (Türkiye)', 'facility': 'Department of Periodontics, Faculty of Dentistry, Bezmialem Vakif University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Nesrin Saruhan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eskisehir Osmangazi Üniversitesi'}, {'name': 'Cenk Fatih Çanakcı, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ataturk University'}, {'name': 'Saime Ozbek Sebin, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ataturk University'}, {'name': 'Humeyra Canakcı, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Buhara Hastanesi'}, {'name': 'Metin İngeç, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ataturk University'}, {'name': 'Ufuk Sezer, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Özel Klinik'}, {'name': 'Ebru Saglam, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saglik Bilimleri Universitesi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezmialem Vakif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}