[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647800":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":18,"responsibleParty":39,"collaborators":41,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":18,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":18,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":69,"whyStopped":18,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":18},{"fullName":5,"class":6},"Ain Shams University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"3D printed intraoral stent group","EXPERIMENTAL","Patients will wear the 3D printed intraoral stent during radiotherapy sessions.",[13],"Device: 3D printed intraoral stents.",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard care control group","NO_INTERVENTION","Patients receiving standard oral care instructions without the use of an intraoral stent (control group).",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","3D printed intraoral stents.","Custom-designed, biocompatible 3D-printed intraoral stent tailored to the patient's oral anatomy. The device will be manufactured using intraoral scanning data , then will be printed using medical-grade resin. During each radiotherapy session for medulloblastoma, the patient will wear the stent inside the mouth to physically displace and shield healthy oral mucosa away from the high-dose radiation target volume, minimizing radiation-induced mucositis.\"",[9],[26],{"name":27,"affiliation":5,"role":28},"Nourhan Mahmoud Shahin, MSc","PRINCIPAL_INVESTIGATOR",[30,34],{"name":27,"role":31,"phone":32,"phoneExt":18,"email":33},"CONTACT","+201065717807","Nourhanshahin@dent.asu.edu.eg",{"name":35,"role":31,"phone":36,"phoneExt":37,"email":38},"Clinical Research Center","+20225351500","7209","irb@57357.org",{"type":40,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[42],{"name":43,"class":6},"Children's Cancer Hospital Egypt 57357","100647800","evaluation-of-the-radioprotective-effect-of-3d-printed-intraoral-stents-in-children-with-brain-cancer-100647800",false,"NCT07715357","Evaluation of The Radioprotective Effect of 3D-Printed Intraoral Stents in Children With Brain Cancer.","Evaluation of The Radioprotective Effect of 3D-Printed Intraoral Stents in Children With Brain Cancer: A Randomized Clinical Trial and An In-Vitro Study","Inclusion Criteria:\n\n1. Patients who will receive 5-7 weeks of definitive radiotherapy for treatment of a diagnosed medulloblastoma tumor.\n2. Age less than 18 years old.\n3. No Evidence of oral mucositis at baseline (WHO grade 0)\n\nExclusion Criteria:\n\n1. Patients with prior exposure to head and neck radiotherapy.\n2. Patients who are unable to wear oral stent.\n3. Patients with known allergies or hypersensitivity to dental resin materials.","ALL","6 Years","18 Years",{"count":55,"type":56},72,"ESTIMATED","INTERVENTIONAL",[59],"NA","Brain cancer patients undergoing radiotherapy may experience oral complications such as oral mucositis, gingival inflammation, plaque accumulation, radiation-induced caries, and reduced oral-health-related quality of life due to scatter radiation affecting oral tissues.\n\nAlthough intraoral stents are used to protect and reposition oral structures during radiotherapy, conventional stents lack standardization in material properties and thickness, leading to variable radioprotective effectiveness. Advances in 3D printing allow fabrication of customized resin intraoral stents with controlled thickness. However, there is not a lot of research in the literature about the materials that are employed as intraoral radiation stents to reduce the radiation dosage received by healthy tissue. Since these devices can lower radiation exposure to healthy tissues, the current study seeks to evaluate the degree of attenuation of therapeutic radiation with four different thicknesses for the intraoral stents and then assess the clinical effectiveness of the optimized thickness of the 3D-printed resin intraoral stent in reducing oral mucositis, periodontal health status, radiation induced caries, and in improving patient-reported outcomes in brain cancer patients undergoing radiotherapy.",[62],"Medulloblastoma Tumor",[64,65,66,67,68],"3D printing","Intraoral stents","Radiation protection","Pediatric Oncology","Radiotherapy","NOT_YET_RECRUITING","2026-07-18",{"date":72,"type":73},"2026-07-21","ACTUAL",{"date":75,"type":56},"2026-09-01",{"date":77,"type":56},"2028-08-01",{"name":5,"class":6}]