Ignite Creation Date:
2025-12-24 @ 5:26 PM
Ignite Modification Date:
2025-12-26 @ 6:38 PM
Study NCT ID:
NCT03594968
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2018-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxidative Stress in Polycystic Ovary Syndrome With Periodontal Disease and Dental Caries Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D003731', 'term': 'Dental Caries'}], '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': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 206}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-01', 'studyFirstSubmitDate': '2018-07-10', 'studyFirstSubmitQcDate': '2018-07-19', 'lastUpdatePostDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FSH hormone ovarian morphology (PCOM)', 'timeFrame': '1 Day', 'description': 'follicle-stimulating hormone \\[FSH\\] is tested by blood sample 6.3\\_24 mlu/ml'}, {'measure': 'luteinizing hormone', 'timeFrame': '1 day', 'description': 'luteinizing hormone \\[LH\\] is tested by blood sample 1.68-15 U/L'}, {'measure': 'dehydroepiandrosterone-sulfate', 'timeFrame': '1 day', 'description': 'dehydroepiandrosterone-sulfate \\[DHEA-S\\] is tested by blood sample 65 to 380 µg/dL or 1.75 to 10.26 µmol/L'}, {'measure': '17-OH-progesterone', 'timeFrame': '1 day', 'description': '17-OH-progesterone is tested by blood sample 20-100 ng/dL'}], 'secondaryOutcomes': [{'measure': 'dental examination', 'timeFrame': '1 Day', 'description': 'All teeth were visually using the International Caries Detection and Assessment System (ICDAS-II). The chosen sites were recorded as: 0 = sound;\n\n1. = first visible sign of noncavitated lesion seen only when the tooth is dried;\n2. = visible noncavitated lesion seen when wet and dry;\n3. = microcavitation in enamel;\n4. = noncavitated lesion extending into dentine seen as an undermining shadow;\n5. = small cavitated lesion with visible dentine: less than 50% of surface;\n6. = large cavitated lesions with visible dentine in more than 50% of the surface.'}, {'measure': 'periodontal examination', 'timeFrame': '1 Day', 'description': 'A single calibrated examiner measured probing depth-PD, 0: healthy\n\nbleeding calculus 3:3.5-5.5 mm 4: over 5.5 mm'}, {'measure': 'Clinical attachment level', 'timeFrame': '1 Day', 'description': 'A single calibrated examiner measured clinical attachment level- CAL, 0: 0-3 mm 1:4-5 mm 2:6-8 mm 3:over 8mm 4: 9-11 mm 5: over 12 mm'}, {'measure': 'Plaque Examination', 'timeFrame': '1 Day', 'description': 'The plaque amount is scored by using Silness\\&Löe Plaque Index Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3.\n\n0:no plaque\n\n1. A film of plaque\n2. soft deposit s within the gingival pocket\n3. Abundance of soft matter within the gingival pocket.\n\nCalculation: Total scores of 6 (16, 12, 24, 36, 32, 44) teeth / No of surfaces examined\n\nHealthy = PI\\<0.4. Mild = PI 0.4-1.0. Moderate = PI 1.1-2. Severe = PI\\>2.'}, {'measure': 'Gingival Examination', 'timeFrame': '1 Day', 'description': '0= Normal gingiva;\n\n1. Mild inflammation\n2. Moderate inflammation\n3. Severe inflammation Calculation: Total scores/ no of surfaces examined 0.1-1:Mild gingivitis, 1.1-2:moderate gingivitis; 2.1-3:severe gingivitis'}, {'measure': 'Bleeding Examination', 'timeFrame': '1 Day', 'description': '0: no bleeding\n\n1: bleeding'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polycystic Ovary Syndrome', 'Dental Caries']}, 'referencesModule': {'references': [{'pmid': '22509751', 'type': 'BACKGROUND', 'citation': 'Ozcaka O, Ceyhan BO, Akcali A, Bicakci N, Lappin DF, Buduneli N. Is there an interaction between polycystic ovary syndrome and gingival inflammation? J Periodontol. 2012 Dec;83(12):1529-37. doi: 10.1902/jop.2012.110588. Epub 2012 Apr 17.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/22509751', 'label': 'Polycystic Ovary Syndrome and Gingival Inflammation'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the oxidative stress parameters in females with polycystic ovary syndrome (PCOS) and clinically healthy. Because of the fact that both oral disease included periodontitis and dental caries, and metabolic syndrome are associated with systemic inflammation, these two disorders may be linked through a common pathophysiologic pathway', 'detailedDescription': 'Power analysis was performed with the G-Power software package to determine sample size. To cover possible data loss, 10% of a group were added to each group. Medical and dental examination will be performed both of control and experimental groups. Age and body mass index (BMI) will be recorded.\n\nIn dental examination decayed, missing, or filled teeth (DMFT) index will be used according to World Health Organization (WHO 1997) criteria. All teeth were visually using the International Caries Detection and Assessment System (ICDAS-II). To analyze the correlation between oral health status and polycystic ovary syndrome linear regression test and for comparison of both the groups (case and control), two sample t test and chi square test were used.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '24 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients were aged from 18 to 24 years, 206 females', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* females with Polycystic Ovary Syndrome\n\nExclusion Criteria:\n\n* history of ovarian surgery, patients with thyroid or prolactin hormone level abnormalities, non-classic 21-hydroxylase deficiency and hormonal therapy, steroid drug use past 6 months, obese patients (body mass index, BMI \\> 35), acute or chronic upper respiratory tract diseases, dental fluorosis, patients using fluoride supplements or orthodontic appliances will not be included in the study.'}, 'identificationModule': {'nctId': 'NCT03594968', 'briefTitle': 'Oxidative Stress in Polycystic Ovary Syndrome With Periodontal Disease and Dental Caries Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Recep Tayyip Erdogan University Training and Research Hospital'}, 'officialTitle': 'Polycystic Ovary Syndrome With Periodontal Disease and Dental Caries', 'orgStudyIdInfo': {'id': '40986104-799'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'polycystic ovary syndrome (PCOS)', 'description': 'Presence of ≥2 of the following:\n\n1. oligomenorrhea and/or anovulation\n2. Hyperandrogenism (clinical and/or biochemical) One of the signs for clinical hyperandrogenism is hirsutism, which represents hair growth in a male pattern on a female with four different degrees of severity in 11 different body parts: 1) upper lip; 2) chin; 3) chest; 4) upper back; 5) lower back; 6) upper abdomen; 7) lower abdomen; 8) arm; 9) forearm; 10) thigh; and 11) lower leg. The Ferriman-Gallwey scoring system is used to score the degree of excess male-pattern body hair to indicate hirsutism.', 'interventionNames': ['Diagnostic Test: polycystic ovary syndrome']}, {'label': 'healthy', 'description': 'healthy patients who had no polycystic ovary', 'interventionNames': ['Diagnostic Test: polycystic ovary syndrome']}], 'interventions': [{'name': 'polycystic ovary syndrome', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['[LH],', '[total T],', '[free T],', '[DHEA-S],', '17-OH-progesterone', '[FSH],'], 'description': "3 to 5th day of the women's normal cycle, we will perform a routine gynecological examination, a basic vaginal ultrasound, a basal hormone profile evaluation", 'armGroupLabels': ['healthy', 'polycystic ovary syndrome (PCOS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53000', 'city': 'Rize', 'country': 'Turkey (Türkiye)', 'facility': 'Recep Tayyip Erdogan University', 'geoPoint': {'lat': 41.02083, 'lon': 40.52194}}], 'overallOfficials': [{'name': 'Gül Yıldız Telatar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Recep Tayyip Erdogan University Dentistry Faculty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be available within 6 months of study finishing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Recep Tayyip Erdogan University Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Gul Yildiz Telatar', 'investigatorAffiliation': 'Recep Tayyip Erdogan University Training and Research Hospital'}}}}