Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-28 @ 3:00 AM
Study NCT ID:
NCT06868550
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-11
First Post:
2025-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Health Promotion Vs. Standard Care in Egyptian Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-07', 'studyFirstSubmitDate': '2025-02-26', 'studyFirstSubmitQcDate': '2025-03-07', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Caries assessment', 'timeFrame': 'Baseline, 38 weeks', 'description': 'Participants will undergo a caries assessment test using the Decayed, Missing, and Filled Teeth (DMFT) index. The DMFT index ranges from 0 to 28 (or 32, depending on the number of teeth present). Higher scores indicate worse oral health, as they reflect more decayed, missing, or filled teeth.'}], 'secondaryOutcomes': [{'measure': 'Oral Hygiene Assessment', 'timeFrame': 'Baseline, Week 12, and week 38', 'description': "Participants' oral hygiene status will be assessed using the Simplified Oral Hygiene Index (OHI-S). The OHI-S score ranges from 0 To 6, where higher scores indicate worse oral hygiene due to increased plaque and debris accumlation."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Maternal and Child Health Outcomes']}, 'descriptionModule': {'briefSummary': 'The research question: In pregnant women, does participation in a comprehensive oral health promotion program, compared to standard care, improve maternal oral health, knowledge, attitudes, and practices? This study aims to evaluate the impact of a comprehensive oral health promotion program, compared to standard care, on improving maternal oral health, knowledge, attitudes, and practices among pregnant women. Null hypothesis: There is no significant difference in maternal oral health, knowledge, attitudes, and practices between the group of Egyptian pregnant women who receive the comprehensive oral health promotion program and those who receive standard care. The study population will be pregnant women aged 20 to 45 years. The participants will be categorized into two groups: Intervention will be offered Comprehensive Program and will Include educational workshops, Videos, pamphlets, and support sessions and group chat; and Comparator group will receive Standard care (Limited to oral health sessions only). The study will evaluate three outcomes. Primary outcome The participants will undergo a caries assessment test using The DMFT Index. Secondary outcome The Oral Hygiene Assessment will include the participants using the Simplified Oral Hygiene Index (OHI-S).\n\nTertiary outcome\n\n1. The knowledge, attitude, and practice (KAP) assessment for pregnant women regarding the Comprehensive Oral Health Promotion Program will be carried out through a prestructured questionnaire. The response data will be collected as frequency and percentage.\n2. The nutritional assessment for all participants will be performed using a prestructured questionnaire. The response data will be recorded as frequency and percentage.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '21 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mothers willing to participate.\n* Pregnant women from 20 to 45 years\n* Participants can understand and communicate\n\nExclusion Criteria:\n\n* Pre-existing systemic conditions such as diabetes or cardiovascular diseases.\n* Participants with a high risk of non-compliance with study requirements'}, 'identificationModule': {'nctId': 'NCT06868550', 'briefTitle': 'Oral Health Promotion Vs. Standard Care in Egyptian Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Impact of a Comprehensive Oral Health Promotion Program on Maternal Oral Health, Knowledge, Attitudes, and Practices Versus Standard Care in a Group of Egyptian Pregnant Women: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CU 26.2.2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Behavioral: Comprehensive oral health program: participants will receive structured oral health education through workshops, videos, pamphlets, and interactive support sessions', 'interventionNames': ['Behavioral: Comprehensive Oral Health Promotion Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator', 'description': 'Behavioral: Standard oral health care: participants will receive routine oral health education in standard care sessions without additional educational materials or interactive support', 'interventionNames': ['Behavioral: Comprehensive Oral Health Promotion Program']}], 'interventions': [{'name': 'Comprehensive Oral Health Promotion Program', 'type': 'BEHAVIORAL', 'description': 'The principal investigator will carry out all treatment procedures, and the patients will be randomly assigned to any of them.', 'armGroupLabels': ['Comparator', 'Intervention']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The collected data will not be shared publicly due to confidentiality policies and ethical restrictions.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sara Mohamed Zaki', 'investigatorAffiliation': 'Cairo University'}}}}