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

NCT07715357 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-07-21

No results posted yet for this study

Summary

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.

Conditions

  • Medulloblastoma Tumor

Interventions

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."

Sponsors & Collaborators

  • Children's Cancer Hospital Egypt 57357

    collaborator OTHER

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Nourhan Mahmoud Shahin, MSc · Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-08-01
Completion
2028-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07715357 on ClinicalTrials.gov