Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-03-13 @ 3:29 AM
Study NCT ID:
NCT06649760
Status:
RECRUITING
Last Update Posted:
2024-10-21
First Post:
2024-10-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Health Education and Message Framing Effect on Oral Health Status of Refugees in Egypt
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003731', 'term': 'Dental Caries'}, {'id': 'D003773', 'term': 'Dental Plaque'}, {'id': 'D005891', 'term': 'Gingivitis'}, {'id': 'D010514', 'term': 'Periodontal Pocket'}, {'id': 'D058225', 'term': 'Plaque, Amyloid'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D003741', 'term': 'Dental Deposits'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 510}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-17', 'studyFirstSubmitDate': '2024-10-12', 'studyFirstSubmitQcDate': '2024-10-17', 'lastUpdatePostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oral health knowledge improvement', 'timeFrame': 'Immediately after structured oral health session, 6 months and 1 year after baseline', 'description': 'To assess change in level of oral health knowledge before and after program using a validated questionnaire'}, {'measure': 'Oral health practices improvement', 'timeFrame': '6 months and 1 year after baseline', 'description': 'Assess toothbrushing and flossing frequency before and after the education session and reminder mobile messages'}, {'measure': 'Oral hygiene status assesment', 'timeFrame': '6 months and 1 year after baseline', 'description': 'measure the change in plaque index scores among participants'}, {'measure': 'Gingival health assessment', 'timeFrame': '6 months and 1 year after baseline', 'description': 'measure the change in gingival index scores among participants'}, {'measure': 'Periodontal health status', 'timeFrame': '6 months and 1 year after baseline', 'description': 'measure the change in CPI index scores among participants'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dental caries', 'Plaque', 'KAP', 'Gingivitis'], 'conditions': ['Knowledge, Attitudes, Practice', 'Caries,Dental', 'Plaque, Dental', 'Gingivitis', 'Pocket, Periodontal']}, 'descriptionModule': {'briefSummary': 'Refugees, facing forced displacement and often exposed to traumatic experiences, represent a vulnerable population with unique healthcare needs. Oral health is considered a prominent factor that contributes to quality of life.\n\nTherefore, this study aim at assessing the effect of message framing on enhancing oral health practices in a group of refugees in Alexandria, Egypt. A three-arm cluster randomized controlled clinical trial will compare a gain-framed mobile text messages group, a loss-framed mobile text messages group, and a control group. The primary outcome is the improvement in oral health practices measured by changes in dental plaque and secondary outcome is to assess change in oral health-related quality of life. In addition, oral health knowledge, attitudes, and practices of refugees will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Refugees older than 18 years old.\n* From Arabic speaking countries.\n* Has been resident in Alexandria, Egypt for at least 6 months.\n* Having mobile phones to receive text messages.\n* Agrees to participate in the study.\n\nExclusion Criteria:\n\n* Planning to move away during 1 year study period.\n* Participating in any kind of oral health education and promotion programs.'}, 'identificationModule': {'nctId': 'NCT06649760', 'briefTitle': 'Oral Health Education and Message Framing Effect on Oral Health Status of Refugees in Egypt', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Effect of Message Framing Through M-Health on Oral Health Conditions and Oral Health Related Quality of Life Among Refugees in Alexandria, Egypt: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'Refugees oral health education'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gain-framed messages', 'description': 'The participants will receive every 2 weeks a boosting reminder mobile text message in a gain-framed way. For example, "Great breath, healthy gums only a toothbrush away" "flossing your teeth daily removes particles of food in the mouth, avoiding bacteria, which promotes great breath."', 'interventionNames': ['Behavioral: Gain and loss framed mobile text messages']}, {'type': 'EXPERIMENTAL', 'label': 'Loss-framed message', 'description': 'he participants will receive every 2 weeks a boosting reminder mobile text message in a loss-framed way. For example, "Brush now and avoid bad breath and gum disease", "If you don\'t floss your teeth daily, particles of food remain in the mouth, collecting bacteria, which causes bad breath."', 'interventionNames': ['Behavioral: Gain and loss framed mobile text messages']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Participants allocated to this group will not receive mobile text messages. They will only receive the oral health education session given to all participants at the beginning.'}], 'interventions': [{'name': 'Gain and loss framed mobile text messages', 'type': 'BEHAVIORAL', 'description': 'To assess the effect of message framing on enhancing oral health practices in a group of refugees', 'armGroupLabels': ['Gain-framed messages', 'Loss-framed message']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21523', 'city': 'Alexandria', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Caritas', 'role': 'CONTACT', 'phone': '+20 2 24 31 02 01'}], 'facility': 'Caritas', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'centralContacts': [{'name': 'Dina Attia, PhD student', 'role': 'CONTACT', 'email': 'dina.ali@alexu.edu.eg', 'phone': '+20 12 80914529'}], 'overallOfficials': [{'name': 'Mona El Kashlan, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alexandria University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Study protocol and assessment forms.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer, Dr.', 'investigatorFullName': 'Dina Youssef Attia', 'investigatorAffiliation': 'Alexandria University'}}}}