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

NCT07715357 | Not Yet Recruiting DMC

• 1 other identifier: FWA00014377
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

3D printing; Intraoral stents; Radiation protection; Pediatric Oncology; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Assessment of the oral mucositis severity in children below 18 years old diagnosed with medulloblastoma tumor.

  Will be assessed using WHO "World Health Organization" Oral Mucositis Scale, Scores range from 0 to 4, where 0 = no mucositis and 4 = severe mucositis preventing oral alimentation. Higher scores indicate more severe oral mucositis (worse outcome).

  Assessments will be carried out weekly during radiotherapy and 3 months after radiotherapy.

Secondary Outcomes (2)

• Priodontal health status .

  Assessment will be carried out weekly during radiotherapy and after 3,6 and 12 months.

• Radiation-induced caries

  Assessment will be before radiotherapy and 3,6,12 months after radiotherapy.

Study Arms (2)

3D printed intraoral stent group

EXPERIMENTAL

Patients will wear the 3D printed intraoral stent during radiotherapy sessions.

Device: 3D printed intraoral stents.

Standard care control group

NO INTERVENTION

Patients receiving standard oral care instructions without the use of an intraoral stent (control group).

Interventions

3D printed intraoral stents. DEVICE

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."

3D printed intraoral stent group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead
• Children's Cancer Hospital Egypt 57357: collaborator

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

Study Officials

• Nourhan Mahmoud Shahin, MSc

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nourhan Mahmoud Shahin, MSc

CONTACT

+201065717807; Nourhanshahin@dent.asu.edu.eg

Clinical Research Center

CONTACT

+20225351500; irb@57357.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Children will be equally allocated into two groups (36/group) according to the use of the stent as follows: Group I (Control group): Patients with the standard oral care instructions. (Without using intraoral stent) "Using intraoral stent is not established as a standard of care for patients receiving radiotherapy until now, so control group will receive only the accepted standard oral care " Group II (Intervention group): Patients who will wear the 3D printed intraoral stent.

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share