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

Official title

Evaluation of The Radioprotective Effect of 3D-Printed Intraoral Stents in Children With Brain Cancer: A Randomized Clinical Trial and An In-Vitro Study

Overview

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.

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."

Primary outcome measures

• Assessment of the oral mucositis severity in children below 18 years old diagnosed with medulloblastoma tumor. [Time frame: Assessments will be carried out weekly during radiotherapy and 3 months after radiotherapy.]

Secondary outcome measures (2)

• Priodontal health status . [Time frame: Assessment will be carried out weekly during radiotherapy and after 3,6 and 12 months.]
• Radiation-induced caries [Time frame: Assessment will be before radiotherapy and 3,6,12 months after radiotherapy.]

Eligibility criteria

Inclusion criteria

• Patients who will receive 5-7 weeks of definitive radiotherapy for treatment of a diagnosed medulloblastoma tumor.
• Age less than 18 years old.
• No Evidence of oral mucositis at baseline (WHO grade 0)

Exclusion criteria

• Patients with prior exposure to head and neck radiotherapy.
• Patients who are unable to wear oral stent.
• Patients with known allergies or hypersensitivity to dental resin materials.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Aggarwal H, Kumar P. Radiation stents: Minimizing radiation-induced complications. South Asian J Cancer. 2014 Jul;3(3):185. doi: 10.4103/2278-330X.136812. No abstract available. PMID 25136529
• Tanem KE, Stensvold E, Wilberg P, Skaare AB, Brandal P, Herlofson BB. Oral and dental late effects in long-term survivors of childhood embryonal brain tumors. Support Care Cancer. 2022 Dec;30(12):10233-10241. doi: 10.1007/s00520-022-07405-8. Epub 2022 Oct 29. PMID 36307656

Identifiers

NCT: NCT07715357 · FWA00014377

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗