[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637716":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":29,"studyPopulation":18,"armGroups":30,"interventions":43,"overallOfficials":18,"centralContacts":52,"locations":18,"responsibleParty":58,"collaborators":18,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":18,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":18,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":85,"whyStopped":18,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":18},{"fullName":5,"class":6},"Cairo University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Oral Hygiene","Oral Hygiene Index-Simplified (OHI-S)\n\nMinimum value: 0\n\nMaximum value: 6\n\nInterpretation of scores:\n\nHigher scores indicate worse oral hygiene (greater debris and calculus accumulation).\n\nLower scores indicate better oral hygiene.","Baseline Measurement and After 1,3 and 6 months",[14],{"measure":15,"description":16,"timeFrame":17},"Oral Health Related Quality Of Life (OHRQoL)","Measured using Child Perception Questionnaire (children aged 8-10 years) Child Perceptions Questionnaire for children aged 8-10 years (CPQ8-10)\n\nMinimum value: 0\n\nMaximum value: 100\n\nInterpretation of scores:\n\nHigher scores indicate a worse oral health-related quality of life (greater negative impact on the child's well-being).\n\nLower scores indicate a better oral health-related quality of life.","Baseline and after 1,3 and 6 months",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":22,"primaryPurpose":23,"observationalModel":18,"timePerspective":18,"maskingInfo":24},"RANDOMIZED","PARALLEL","Participants will be allocated into two groups: an immediate intervention group and a waitlist control group. Both groups will undergo baseline assessment. The intervention group will receive the structured oral health educational program, while the waitlist group will receive routine care. After 3 months, both groups will be reassessed. Subsequently, the educational program will be provided to the waitlist group to ensure ethical equity.","PREVENTION",{"masking":25,"maskingDescription":18,"whoMasked":26},"DOUBLE",[27,28],"INVESTIGATOR","OUTCOMES_ASSESSOR","Benefits to the patient\n\n* The clinical examination and OHRQoL assessments provide a well-established foundation to plan the oral-dental treatment for each individual.\n* Improved awareness among β-thalassemia patients and caregivers regarding oral hygiene practices and the importance of regular dental visits may contribute to better oral health outcomes and enhanced overall quality of life.\n\nBenefits to the community\n\n* Provide valuable epidemiological data on the oral health status and oral health-related quality of life in children with β-thalassemia.\n* Assist dental professionals, healthcare providers, and policymakers in planning targeted preventive strategies and integrating oral health care into the comprehensive management of thalassemia.",[31,37],{"label":32,"type":33,"description":34,"interventionNames":35},"an Immediate Intervention Group","EXPERIMENTAL","oral health educational program will be given to this group of patients",[36],"Other: oral health educational program for Immediate Intervention Group",{"label":38,"type":39,"description":40,"interventionNames":41},"Waitlist Control Group","PLACEBO_COMPARATOR","routine oral hygiene instructions will be given to this group of children",[42],"Other: routine oral hygiene instructions",[44,48],{"type":6,"name":45,"description":46,"armGroupLabels":47,"otherNames":18},"oral health educational program for Immediate Intervention Group","Oral Health Educational Program\n\nEducational Content (Oral health educational session) including:\n\n* Interactive lectures with visual aids and video demonstration\n* Correct Tooth brushing technique\n* Frequency \\& time of brushing\n* How to use mouth rinse and toothpaste\n* How to properly use the dental floss\n\nTeaching Methods\n\n* Demonstration on dental models\n* Hands-on supervised brushing\n* Use of disclosing agents\n\nMotivational Interviewing\n\n* Caregiver's guide booklet\n* Dietary counseling\n* Importance of mouth rinse and fluoridated tooth pastes\n\nMaterials Used\n\n* Ultra soft Toothbrushes\n* Alcohol-free mouth rinse\n* Use of fluoridated toothpaste\n* Interdental floss\n* Oral health promotion leaflet",[32],{"type":6,"name":49,"description":50,"armGroupLabels":51,"otherNames":18},"routine oral hygiene instructions","Use toothbrush and toothpaste for oral hygiene Brush twice daily Regular dental checkups Keep toothbrush clean",[38],[53],{"name":54,"role":55,"phone":56,"phoneExt":18,"email":57},"Mariam MohamedDia Shafie, Bachelor of Dental Surgery","CONTACT","+01226602585","mariam.diaaeldin@dentistry.cu.edu.eg",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Mariam Mohamed Mohamed Diaa eldin Shafie","Principal Investigator","100637716","oral-health-status-in-children-with--thalassemia-major-100637716",false,"NCT07614217","Oral Health Status in Children With β-Thalassemia Major","Effectiveness of a Structured Oral Health Educational Program on Oral Hygiene and Oral Health Related Quality of Life in Children With β-Thalassemia Major: Randomized Clinical Trial.","Inclusion Criteria:\n\n* Children having medical records confirmed of β-thalassemia diagnosis.\n* Age range between 8-10 years old.\n* Have acceptable cooperation\n\nExclusion Criteria:\n\n* Children with Cognitive impairment.\n* Participants in another oral health education program or clinical study within the past 6 months will be excluded.\n* Unstable clinical condition as judged by the treating physician","ALL","8 Years","10 Years",{"count":73,"type":74},46,"ESTIMATED","INTERVENTIONAL",[77],"NA","To evaluate the effectiveness of a structured oral health educational program on oral hygiene status and oral health-related quality of life (OHRQoL) among children diagnosed with β-thalassemia.",[80],"B Thalassemia Major",[82,83,84],"oral health related quality of life","oral health status","Beta Thalassemia Major children","NOT_YET_RECRUITING","2026-10-03",{"date":88,"type":89},"2026-10-07","ACTUAL",{"date":91,"type":74},"2026-11-01",{"date":93,"type":74},"2027-12",{"name":5,"class":6}]