Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 12:03 AM
Study NCT ID:
NCT03575494
Status:
WITHDRAWN
Last Update Posted:
2020-10-08
First Post:
2018-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Oral Health Status and Unexplained Female Infertility in Turkish Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}, {'id': 'D007247', 'term': 'Infertility, Female'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic 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': 'D007246', 'term': 'Infertility'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'this study does not need to get a clinicaltrials number', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-04-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-02-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-06', 'studyFirstSubmitDate': '2018-06-22', 'studyFirstSubmitQcDate': '2018-06-22', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'female infertility', 'timeFrame': '12 months', 'description': 'Women with normal hormone values and uterine cavity with at least one healthy fallopian tube.\n\nAll male partners have a semen specimen with minimum 5 million motile sperm in the ejaculate.'}], '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:\n\n0 = 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. A single calibrated examiner measured probing depth-PD, clinical attachment level- CAL, plaque (Pl), and gingival indices (GI), bleeding on probing (BOP) at four sites per tooth using a manual periodontal probe (PCPUNC, Hu-Friedy, Chicago, IL, USA).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Caries', 'Female Infertility']}, 'referencesModule': {'references': [{'pmid': '29162952', 'type': 'BACKGROUND', 'citation': 'Khanna SS, Dhaimade PA, Malhotra S. Oral Health Status and Fertility Treatment Including IVF. J Obstet Gynaecol India. 2017 Dec;67(6):400-404. doi: 10.1007/s13224-017-1025-0. Epub 2017 Jun 20.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/29162952', 'label': 'Oral Health Status and Fertility Treatment'}]}, 'descriptionModule': {'briefSummary': 'Periodontal diseases and dental caries are initiated by a pathogenic biofilm, in a susceptible host, affecting the tooth periodontium and hard tissues. Its possible association with many biologic systems has been studied. In this study, researchers investigated association between oral health and female infertility, and what is the biological rationale for such relationship.', 'detailedDescription': 'Power analysis was performed with the G-Power software package to determine sample size.\n\nTo 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. In 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).\n\nTo analyze the correlation between oral health status and female infertility 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': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients were aged from 18 to 35 years, 100 females', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women who had regular menses and can't conceive despite a long-term regular sexual intercourse for more than 12 months\n* Women with normal hormone values and uterine cavity with at least one healthy fallopian tube.\n* All male partners have a semen specimen with minimum 5 million motile sperm in the ejaculate.\n* The control group members have minimum two normal pregnancies\n\nExclusion Criteria:\n\n* Patients who have history of f; hydrosalpinx, polycystic ovarian syndrome, endometriosis grade 3-4, thyroid disease, tubal surgery, hyperprolactinemia, autoimmune diseases, diabetes mellitus, uterine/cervical anomalies, active liver disease, cardiovascular disease, premature ovarian failure, smoking and alcohol consumption, poor socioeconomic level, HIV-infected, obesity (body mass index ≥ 30 kg/m2), chronic upper respiratory tract diseases and dental fluorosis.\n* Patients using fluoride supplements and orthodontic appliances"}, 'identificationModule': {'nctId': 'NCT03575494', 'briefTitle': 'Relationship Between Oral Health Status and Unexplained Female Infertility in Turkish Population', 'organization': {'class': 'OTHER', 'fullName': 'Recep Tayyip Erdogan University Training and Research Hospital'}, 'officialTitle': 'Oral Health Status and Unexplained Female Infertility', 'orgStudyIdInfo': {'id': '40465587-177'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'female infertility', 'description': "Women who had regular menses and can't conceive despite a long-term regular sexual intercourse for more than 12 months", 'interventionNames': ['Other: Intraoral and Radiographic Dental Examination']}, {'label': 'healthy', 'description': 'healthy patients who had minimum two normal pregnancies', 'interventionNames': ['Other: Intraoral and Radiographic Dental Examination']}], 'interventions': [{'name': 'Intraoral and Radiographic Dental Examination', 'type': 'OTHER', 'description': '(ORTHOPANTOMOGRAPH® OP300 PANORAMIC, Instrumentarium Dental, Tuusula, Finland,63 kVp, 0.8 mA, 0.5 s).', 'armGroupLabels': ['female infertility', 'healthy']}]}, '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': 'Recep Tayyip Erdogan University Faculty of Dentistry', 'investigatorFullName': 'Gul Yildiz Telatar', 'investigatorAffiliation': 'Recep Tayyip Erdogan University Training and Research Hospital'}}}}