Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT07184320
Status:
RECRUITING
Last Update Posted:
2025-09-19
First Post:
2025-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of AI-Based Video Education on Denture Care and Oral Health-Related Quality of Life Among Older Adults: A Nursing-Prosthodontic Collaborative Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-13', 'studyFirstSubmitDate': '2025-09-13', 'studyFirstSubmitQcDate': '2025-09-13', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Oral Health-Related Quality of Life (OHIP-14 Score)', 'timeFrame': 'Baseline, immediately post-intervention, 1 month, 2 months, and 3 months', 'description': 'The primary outcome is the mean change in OHIP-14 total score from baseline to follow-up assessments.'}], 'secondaryOutcomes': [{'measure': 'Change in Denture Care Knowledge Retention Score', 'timeFrame': 'Baseline, immediately post-intervention, 1 month, 2 months, and 3 months', 'description': 'Measured using a structured denture care knowledge quiz assessing correct cleaning frequency, storage methods, avoidance of harmful practices, recognition of poor fit, and oral hygiene procedures.'}, {'measure': 'Patient Satisfaction with Educational Method', 'timeFrame': 'Immediately post-intervention, 1 month, 2 months, and 3 months', 'description': 'Measured using a 5-point Likert scale questionnaire evaluating clarity, usefulness, acceptability, and confidence in applying denture care practices after receiving the assigned intervention (AI-based video or conventional oral instruction).'}, {'measure': 'Compliance with Denture Hygiene Practices', 'timeFrame': '1 month, 2 months, and 3 months post-intervention', 'description': 'Assessed with a structured self-reported checklist of daily denture care practices, including cleaning frequency, storage behaviour, and oral mucosal care.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Digital Health Education', 'Denture Care', 'Patient Education', 'Interdisciplinary Care', 'Prosthodontics'], 'conditions': ['Complete Edentulism', 'Partial Denture', 'Partial Edentulism in the Maxilla or in the Mandible']}, 'descriptionModule': {'briefSummary': 'To assess the effectiveness of AI-based educational videos in improving patient-reported oral health outcomes.', 'detailedDescription': 'This study adopts a two-arm, parallel-group randomised controlled trial (RCT) design to compare the effectiveness of AI-based video education versus conventional oral health instruction in improving denture care knowledge, patient satisfaction, and oral health-related quality of life among older adults wearing removable prostheses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 50 years old.\n* Patients are removable denture users.\n* Patients can consent.\n* Patients who completed follow-up.\n\nExclusion Criteria:\n\n* Patients with cognitive impairment.\n* Participants are currently rehabilitated with fixed prostheses.\n* Patients received prior structured education in the last 6 months.'}, 'identificationModule': {'nctId': 'NCT07184320', 'briefTitle': 'The Impact of AI-Based Video Education on Denture Care and Oral Health-Related Quality of Life Among Older Adults: A Nursing-Prosthodontic Collaborative Study', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'The Impact of AI-Based Video Education on Denture Care and Oral Health-Related Quality of Life Among Older Adults: A Nursing-Prosthodontic Collaborative Study', 'orgStudyIdInfo': {'id': 'IRB-COD-FAC-06-Aug-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AI-Based Video Education', 'description': 'Participants will receive structured AI-based video education on denture care', 'interventionNames': ['Behavioral: AI-Based Video Education on Denture Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Oral Health Instruction', 'description': 'Participants will receive conventional chairside verbal oral health instruction from the prosthodontic team on denture care', 'interventionNames': ['Behavioral: Conventional Oral Health Instruction']}], 'interventions': [{'name': 'AI-Based Video Education on Denture Care', 'type': 'BEHAVIORAL', 'description': 'The intervention consists of an AI-based educational video module, approximately 8 minutes in duration, designed to improve denture care practices. It uses step-by-step, visually engaging demonstrations with AI-guided narration to enhance understanding, recall, and adherence.', 'armGroupLabels': ['AI-Based Video Education']}, {'name': 'Conventional Oral Health Instruction', 'type': 'BEHAVIORAL', 'description': 'Participants in the control group will receive conventional oral health education delivered verbally and chairside by the prosthodontic team. The standardized instruction includes information on denture hygiene techniques, appropriate storage of dentures overnight, mucosal care', 'armGroupLabels': ['Conventional Oral Health Instruction']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ajman', 'state': 'Ajman Emirate', 'status': 'RECRUITING', 'country': 'United Arab Emirates', 'contacts': [{'name': 'SHERIF A S SADEK', 'role': 'CONTACT', 'email': 'sherifalysadek@gmail.com', 'phone': '+971564252210'}, {'role': 'CONTACT', 'email': 'sherifalysadek@gmail.com'}, {'name': 'SHERIF A S SADEK', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sienna Marie J Gonzalez', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Gulf Medical University', 'geoPoint': {'lat': 25.40177, 'lon': 55.47878}}], 'centralContacts': [{'name': 'Sherif A S Sadek', 'role': 'CONTACT', 'email': 'sherifalysadek@gmail.com', 'phone': '+971564252210'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Only de-identified, aggregate outcome data (summary of OHIP-14 scores, knowledge quiz results, and satisfaction ratings) will be shared. Individual-level raw data will not be shared. Data will be made available in summary tables upon reasonable request for academic purposes, subject to approval by the principal investigator and the Institutional Review Board.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sherif Aly Sadek', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gulf Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sherif Aly Sadek', 'investigatorAffiliation': 'Cairo University'}}}}