Evaluation of The Radioprotective Effect of 3D-Printed Intraoral Stents in Children With Brain Cancer.

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. Although 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.

NCT Number	NCT07715357
Lead Sponsor	Ain Shams University Collaborators: Children's Cancer Hospital Egypt 57357
Conditions	Medulloblastoma Tumor
Enrollment	72 participants
Start Date	2026-09-01
Primary Completion	2028-08-01 (estimated)
Study Completion	2028-08-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-21