Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2026-01-10 @ 9:43 AM
Study NCT ID:
NCT03336957
Status:
COMPLETED
Last Update Posted:
2017-11-08
First Post:
2017-11-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stress and Gingival Inflammation in Non-pregnant and Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D005891', 'term': 'Gingivitis'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010512', 'term': 'Periodontal Index'}], 'ancestors': [{'id': 'D003753', 'term': 'Dental Health Surveys'}, {'id': 'D006306', 'term': 'Health Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D010517', 'term': 'Periodontics'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D011636', 'term': 'Public Health Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-06', 'studyFirstSubmitDate': '2017-11-02', 'studyFirstSubmitQcDate': '2017-11-06', 'lastUpdatePostDateStruct': {'date': '2017-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'salivary Cg A hormone concentration', 'timeFrame': 'up to 8 weeks', 'description': 'Samples should be taken before and after treatment and evaluated using ELISA kits'}], 'secondaryOutcomes': [{'measure': 'IL-1β and IL-10 Cytokine levels in the GCF', 'timeFrame': 'up to 8 weeks', 'description': 'Samples should be taken before and after treatment and evaluated using ELISA kits'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chromogranin A, stress, gingivitis, pregnancy'], 'conditions': ['Periodontal Diseases', 'Pregnancy Gingivitis']}, 'referencesModule': {'references': [{'pmid': '30043934', 'type': 'DERIVED', 'citation': 'Yarkac FU, Gokturk O, Demir O. Effect of non-surgical periodontal therapy on the degree of gingival inflammation and stress markers related to pregnancy. J Appl Oral Sci. 2018 Jul 23;26:e20170630. doi: 10.1590/1678-7757-2017-0630.'}]}, 'descriptionModule': {'briefSummary': 'Background: The purpose of the present study is to research whether stress scale scores alter with relationship to gingival inflammation and examine the impact of non-surgical periodontal therapy during pregnancy on the levels of cytokines in gingival crevicular fluid (GCF) and on salivary stress-related hormones.\n\nMethods: 30 non-pregnant (control group) and 30 pregnant women (test group) who fulfilled the study inclusion criteria were chosen. The participants with moderate/severe gingivitis were included. Clinical data and samples of GCF and salivary were collected at baseline and after periodontal therapy. The levels of cytokines interleukin-1 beta (IL-1β) and IL-10, and concentration of salivary chromogranin A (Cg A) hormone were analyzed by enzyme-linked immunosorbent assay kits.', 'detailedDescription': 'Periodontal clinical measurements and periodontal treatment were applied by a previously trained and calibrated examiner. Clinical parameters measurements including; probing pocket depths (PPD; the distance from the gingival margin to the base of the gingival sulcus), clinical attachment level (CAL), full mouth gingival index (GI)21 and plaque index (PI)20 scores using a periodontal probe were registered following saliva and GCF sample collection. Then, non-surgical periodontal therapy (NPT) consisted of scaling, root planning, and oral hygiene instruction was applied. Clinical measurements, recruitment of GCF, and saliva samples were repeated after three weeks.\n\nGingival Crevicular Fluid and Saliva Sample Collection Selected anterior teeth for GCF sampling were isolated from saliva using cotton rolls, a gentle stream of air was conducted parallel to the root surface for 5 to 10 seconds to dry the area.\n\nThe periopaper strips were gently inserted into the gingival crevice until resistance was felt and were left in place for 30 s and were collected from mesio-buccal sulcus of teeth in the anterior region of each patient (two samples per patient and per visit). The samples containing blood were discarded and were placed in sterile Eppendorf tubes and were stored at -20°C until the assay procedure.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Must be systemically healthy;\n2. Must be at least twenty teeth in the mouth;\n3. Clinical diagnosis of gingivitis;\n4. Must be the probing pocket depth (PPD)≤3 mm in all four quadrants.\n\nExclusion Criteria:\n\n* the use of anti-inflammatory,\n* antimicrobial and hormone therapy within the preceding 6 months,\n* having psychiatric disorders,\n* a systemic disease,\n* smoking cigarettes and\n* for the control group breastfeeding, pregnancy and menstrual periods.'}, 'identificationModule': {'nctId': 'NCT03336957', 'briefTitle': 'Stress and Gingival Inflammation in Non-pregnant and Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Tokat Gaziosmanpasa University'}, 'officialTitle': 'Effect of Non-Surgical Periodontal Therapy on Pregnancy-Related Degree of Gingival Inflammation and Stress Markers', 'orgStudyIdInfo': {'id': '15-KAEK-154'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pregnant group', 'description': 'Test group, non-surgical periodontal therapy (NPT) consisted of scaling and oral hygiene instruction was applied. IL- 1β AND IL-10 in the GCF and Cg A in saliva samples were taken before and after periodontal treatment.', 'interventionNames': ['Procedure: periodontal treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-Pregnant', 'description': 'Control group, non-surgical periodontal therapy (NPT) consisted of scaling and oral hygiene instruction was applied. IL- 1β AND IL-10 in the GCF and Cg A in saliva samples were taken before and after periodontal treatment.', 'interventionNames': ['Procedure: periodontal treatment']}], 'interventions': [{'name': 'periodontal treatment', 'type': 'PROCEDURE', 'description': 'non-surgical periodontal therapy (NPT) consisted of scaling, root planning, and oral hygiene instruction', 'armGroupLabels': ['Non-Pregnant', 'Pregnant group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'individual participant data for all primary and secondary outcome measures will be made available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tokat Gaziosmanpasa University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ozge Gokturk', 'investigatorAffiliation': 'Tokat Gaziosmanpasa University'}}}}