Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2025-12-30 @ 11:59 AM
Study NCT ID:
NCT04315532
Status:
COMPLETED
Last Update Posted:
2020-03-23
First Post:
2020-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Periodontal Treatment on Stress and Pregnancy Relationship
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-19', 'studyFirstSubmitDate': '2020-03-18', 'studyFirstSubmitQcDate': '2020-03-18', 'lastUpdatePostDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dehydroepiandrosterone (DHEA)', 'timeFrame': 'Baseline and after 8 weeks', 'description': 'The changes in DHEA levels within 8 weeks. Higher values represent a worse outcome. The decrease in DHEA levels is expected after periodontal treatment.'}, {'measure': 'estrogen', 'timeFrame': 'Baseline and after 8 weeks', 'description': 'The changes in estrogen levels within 8 weeks. Higher values represent a worse outcome. The decrease in estrogen levels is expected after periodontal treatment.'}], 'secondaryOutcomes': [{'measure': 'Gingival index', 'timeFrame': 'Baseline and after 8 weeks', 'description': 'The changes in gingival index level after periodontal treatment. Gingival index was measured for determining the severity of disease and clinical outcome. Higher values represent a worse outcome. After periodontal treatment, a reduction in gingival index value is expected.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stress'], 'conditions': ['Pregnancy Gingivitis']}, 'descriptionModule': {'briefSummary': 'There is a relationship between stress and pregnancy gingivitis. This relationship may be double-sided.', 'detailedDescription': 'The aim of this clinical study was to determine the effect of non-surgical mechanical periodontal treatment on sex steroid and stress markers at pregnancy gingivitis. A total of 84 subjects; 22 pregnant women with gingivitis (group 1) and 25 pregnant women with periodontal healthy (pregnant group), group 2), 22 non-pregnant women with gingivitis (group 3) and 15 non-pregnant women with periodontal healthy (non-pregnant group), group 4) participated in this study. Clinically, plaque index, gingival index, and probing pocket depth were measured at baseline and after therapy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '24 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* being between the ages of 24-50\n* being pregnant for 23-30 weeks (for pregnant individuals)\n* not smoking.\n\nExclusion Criteria:\n\n* using antimicrobial or anti-inflammatory therapy within the previous 3 months,\n* having systemic disease,\n* having periodontitis,\n* having deep caries lesions, and remnant roots and\n* having lactation'}, 'identificationModule': {'nctId': 'NCT04315532', 'briefTitle': 'The Effect of Periodontal Treatment on Stress and Pregnancy Relationship', 'organization': {'class': 'OTHER', 'fullName': 'Tokat Gaziosmanpasa University'}, 'officialTitle': 'Relationship of Sex Steroid and Stress Markers in Saliva and Gingival Crevicular Fluid With Pregnancy', 'orgStudyIdInfo': {'id': '2018.06.05.1298'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pregnancy Group', 'description': 'GCF and saliva samples were taken from pregnant gingivitis patients before treatment and after 8 weeks. GCF and saliva samples were taken from pregnant periodontal healty individuals baseline and after 8 weeks.\n\nIntervention: Non-surgical periodontal treatment was performed for pregnant gingivitis patients. Gingival crevicular fluid (GCF) and saliva samples were taken.', 'interventionNames': ['Other: Non-surgical periodontal treatment', 'Other: Saliva samples', 'Other: GCF samples']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-Pregnancy Group', 'description': 'GCF and saliva samples were taken from non-pregnant gingivitis patients before treatment and after 8 weeks. GCF and saliva samples were taken from periodontal healty individuals baseline and after 8 weeks.\n\nIntervention: Non-surgical periodontal treatment was performed for non-pregnant gingivitis patients. Gingival crevicular fluid (GCF) and saliva samples were taken.', 'interventionNames': ['Other: Non-surgical periodontal treatment', 'Other: Saliva samples', 'Other: GCF samples']}], 'interventions': [{'name': 'Non-surgical periodontal treatment', 'type': 'OTHER', 'description': 'Non-surgical periodontal treatment was performed for pregnant and non-pregnant gingivitis patients. Gingival crevicular fluid (GCF) and saliva samples were taken from all patients baseline and after 8 weeks.', 'armGroupLabels': ['Non-Pregnancy Group', 'Pregnancy Group']}, {'name': 'Saliva samples', 'type': 'OTHER', 'description': 'Saliva samples were taken from patients for the evaluation of sex steroid and stress markers baseline and after 8 weeks.', 'armGroupLabels': ['Non-Pregnancy Group', 'Pregnancy Group']}, {'name': 'GCF samples', 'type': 'OTHER', 'description': 'GCF samples were taken from patients for the evaluation of stress markers baseline and after 8 weeks.', 'armGroupLabels': ['Non-Pregnancy Group', 'Pregnancy Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ozge Gokturk', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Abant Izzet Baysal'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tokat Gaziosmanpasa University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abant Izzet Baysal University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ozge Gokturk', 'investigatorAffiliation': 'Tokat Gaziosmanpasa University'}}}}