Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT05513118
Status:
COMPLETED
Last Update Posted:
2022-09-30
First Post:
2022-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Menopause and Oral Health
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-29', 'studyFirstSubmitDate': '2022-08-21', 'studyFirstSubmitQcDate': '2022-08-21', 'lastUpdatePostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Periodontitis', 'timeFrame': '1 month', 'description': 'Interdental attachment loss is detectable at ≥2 non-adjacent teeth, or buccal/oral attachment loss ≥3 mm with pocketing \\>3 mm at ≥2 adjacent teeth were present.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Menopause', 'Periodontal Diseases']}, 'descriptionModule': {'briefSummary': "Menopause is characterized by major physiological and concomitant psychological changes. The study aimed to evaluate the association between oral health parameters, bone mineral density (BMD) and physiological or psychological symptoms in post-menopausal women (PMW), compared with regularly menstruating women (RMW). Inflammatory biomarker levels in gingival crevicular fluid, saliva, serum and determination of microbial niches in subgingival plaque samples were further aimed. The participants were asked to complete the Women's Health Questionnaire to measure emotional and physical well-being.\n\nA total of 148 women (PMW, n=76,RMW, n=72) received a comprehensive medical assessment and a full-mouth oral examination. The corresponding bone mineral density (BMD) and body mass indices (BMI) were obtained from their medical records."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population comprised of two main groups as postmenopausal women (PMW) and regularly menstruating women (RMW). The women in the PMW group were included if they were under 65 years of age and had a history of spontaneous amenorrhea for the last 12 months.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being 35-65 years of age\n* Having history of spontaneous amenorrhea for the last 12 months for PMW.\n* Lack of irregularity in menstrual cycles during the past 12 months for RMPW.\n* Possessing at least 10 natural teeth without any prosthetic restoration\n\nExclusion Criteria:\n\n* History of antibiotics use in last 3 months\n* Ongoing cancer therapy\n* Presence of oral ulcers or acute infectious disease\n* Presence of diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT05513118', 'briefTitle': 'Menopause and Oral Health', 'organization': {'class': 'OTHER', 'fullName': 'Ege University'}, 'officialTitle': 'Evaluation of the Relationship Between Menopause and Periodontal Health With Biochemical and Microbiological Parameters', 'orgStudyIdInfo': {'id': 'TOA-2020-21085'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Post-menopausal women', 'interventionNames': ['Diagnostic Test: Periodontal clinical examination and gingival crevicular fluid, saliva, dental plaque, serum sampling']}, {'label': 'Regularly mensturating women', 'interventionNames': ['Diagnostic Test: Periodontal clinical examination and gingival crevicular fluid, saliva, dental plaque, serum sampling']}], 'interventions': [{'name': 'Periodontal clinical examination and gingival crevicular fluid, saliva, dental plaque, serum sampling', 'type': 'DIAGNOSTIC_TEST', 'description': 'Probing pocket depth was defined as the distance in millimeters from the gingival margin to the base of the gingival sulcus measured using a manual probe (Michigan 0 probe with Williams Markings) in all the teeth present except for third molars. Similarly, clinical attachment level (CAL) was measured as distance from cementoenamel junction to the base of pocket and recorded manually to the nearest millimeter marking on probe.\n\n1 mililiter of saliva was obtained by each participant. Subgingival dental plaque was collected with sterile endodontic paperpoints from mesial sides of each natural teeth without a prostethic restoration. Gingival crevicular fluid samples were collected with absorbent paper strips. Serum samples were also collected at the time of visit.', 'armGroupLabels': ['Post-menopausal women', 'Regularly mensturating women']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Ege University Faculty of Dentistry', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ege University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karolinska Institutet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Gülnur Emingil', 'investigatorAffiliation': 'Ege University'}}}}