Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2026-02-20 @ 6:33 PM
Study NCT ID:
NCT02613468
Status:
COMPLETED
Last Update Posted:
2015-11-25
First Post:
2015-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Periodontal Condition in Pregnancy and Low Birth Delivery Incidence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001724', 'term': 'Birth Weight'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D005891', 'term': 'Gingivitis'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 269}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-23', 'studyFirstSubmitDate': '2015-11-13', 'studyFirstSubmitQcDate': '2015-11-21', 'lastUpdatePostDateStruct': {'date': '2015-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of pregnancies', 'timeFrame': 'At 9th months', 'description': 'Number of pregnancies (numbers)'}, {'measure': 'Birth weight', 'timeFrame': 'At 9th months', 'description': 'Birth weight (kg)'}], 'secondaryOutcomes': [{'measure': 'Probing pocket depth', 'timeFrame': 'average of 2nd months, 5th months and 8th months', 'description': 'The changes in probing pocket depth in time frame.Probing pocket depth was measured for determining severity of disease and clinic outcome.'}, {'measure': 'Clinical attachment level', 'timeFrame': 'average of 2nd months, 5th months and 8th months', 'description': 'The changes in clinical attachment level in time frame. Clinical attachment level was measured for determining severity of disease and clinic outcome.'}, {'measure': 'Gingival index', 'timeFrame': 'average of 2nd months, 5th months and 8th months', 'description': 'The changes in gingival index in time frame. Gingival index was recorded for classifying and evaluating (coronally) gingival inflammation.'}, {'measure': 'Plaque index', 'timeFrame': 'average of 2nd months, 5th months and 8th months', 'description': 'The changes in plaque index in time frame. Plaque index was recorded for determining and classifying oral hygiene status.'}, {'measure': 'Bleeding on probing', 'timeFrame': 'average of 2nd months, 5th months and 8th months', 'description': 'The changes in bleeding on probing in time frame. Bleeding on probing was recorded for classifying and evaluating (apically) gingival inflammation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pregnancy', 'Low birth weight', 'Gingivitis', 'Inflammation', 'Periodontitis'], 'conditions': ['Pregnancy', 'Birth Weight', 'Periodontal Diseases']}, 'descriptionModule': {'briefSummary': 'The objective of this study was the evaluation of periodontal condition in pregnant women and the effect of the treatment of periodontal disease upon low birth weight.', 'detailedDescription': "This research was carried out in the following three centers: Samsun Birth and Children's Hospital, Department of Obstetrics and Gynecology of the Faculty of Medicine and Faculty of Dentistry of the University of Ondokuz Mayıs. 269 women in their first trimester were included in this study. Their ages ranged from 18-35 years, their height was above 150 cm and they have no history of any systemic disease. At the end of each trimester these measurements were performed: attachment level, probing depth, gingival index, plaque index, and bleeding on probing. According to the periodontal diagnosis the research population was divided into three groups: periodontally healthy women; periodontally diseased women, however rejection of treatment; periodontally diseased women, however acceptance of treatment.In this study one-way ANOVA, chi-square, conditional logistic regression analyses were used."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age:18-35 years\n* Sure of her dates\n\nExclusion Criteria:\n\n* systemic diseases (i.e., diabetes mellitus, cancer, hypertension, urolithiasis, parathyroid disease, diseases that compromise pregnancy)\n* Less than two pregnancy'}, 'identificationModule': {'nctId': 'NCT02613468', 'briefTitle': 'Periodontal Condition in Pregnancy and Low Birth Delivery Incidence', 'organization': {'class': 'OTHER', 'fullName': 'Ondokuz Mayıs University'}, 'officialTitle': 'A Comparative Evaluation in Pregnant Women of the Periodontal Condition and Low Birth Delivery Incidence', 'orgStudyIdInfo': {'id': 'OndokusMu'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Periodontally healthy', 'description': 'Some periodontal measurements (attachment level, probing depth, gingival index, plaque index, and bleeding on probing) were performed in periodontally healthy pregnant. These measurements were performed at the end of each trimester.\n\nParameters such as number of pregnancies, previous low birth weight, prenatal care, genital tract infection, use of antibiotics, smoking, tooth brushing habit and birth weight were evaluated.\n\nIntervation: Collection of periodontal records and pregnancy parameters.', 'interventionNames': ['Other: collection of periodontal records', 'Other: pregnancy parameters']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Periodontally diseased, untreated', 'description': 'This group is comprised of individuals who do not accept treatment Some periodontal measurements (attachment level, probing depth, gingival index, plaque index, and bleeding on probing) were performed in periodontally healthy pregnant. These measurements were performed at the end of each trimester.\n\nParameters such as number of pregnancies, previous low birth weight, prenatal care, genital tract infection, use of antibiotics, smoking, tooth brushing habit were evaluated.\n\nBirth weight was recorded at the end of pregnancy.', 'interventionNames': ['Other: collection of periodontal records', 'Other: pregnancy parameters']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Periodontally diseased, treated', 'description': 'This group is comprised of individuals who agree to treatment. Some periodontal measurements (attachment level, probing depth, gingival index, plaque index, and bleeding on probing) were performed in periodontally healthy pregnant. These measurements were performed at the end of each trimester.\n\nParameters such as number of pregnancies, previous low birth weight, prenatal care, genital tract infection, use of antibiotics, smoking, tooth brushing habit were evaluated.\n\nInitial Periodontal Therapy is completed (calculus elimination, root planning, polishing etc.) This treatment is considered to be the safest time for pregnant mothers was performed in 2 trimester.\n\nBirth weight was recorded at the end of pregnancy. Intervation: Collection of periodontal records and pregnancy parameters.', 'interventionNames': ['Other: collection of periodontal records', 'Other: pregnancy parameters', 'Other: Initial Periodontal Therapy']}], 'interventions': [{'name': 'collection of periodontal records', 'type': 'OTHER', 'description': '1. Clinic attachment level\n2. Probing depth\n3. Gingival index\n4. Plaque index\n5. Bleeding on probing were performed in all groups. These measurements were performed at the end of each trimester.', 'armGroupLabels': ['Periodontally diseased, treated', 'Periodontally diseased, untreated', 'Periodontally healthy']}, {'name': 'pregnancy parameters', 'type': 'OTHER', 'description': 'Parameters such as number of pregnancies, previous low birth weight, prenatal care, genital tract infection, use of antibiotics, smoking, tooth brushing habit and birth weight were evaluated.', 'armGroupLabels': ['Periodontally diseased, treated', 'Periodontally diseased, untreated', 'Periodontally healthy']}, {'name': 'Initial Periodontal Therapy', 'type': 'OTHER', 'description': 'Initial Periodontal Therapy is completed ( Supragingival and subgingival calculus elimination, root planning, polishing etc.) This treatment is considered to be the safest time for pregnant mothers was performed in 2 trimester.', 'armGroupLabels': ['Periodontally diseased, treated']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ondokuz Mayıs University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'İnci Devrim', 'investigatorAffiliation': 'Ondokuz Mayıs University'}}}}