NCT07715357Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 21 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- First submitted
- 15 Jul 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 1 Aug 2028
- Lead sponsor
- Ain Shams University
- Diseases
- Childhood cancers
- NCT number
- NCT07715357
What you commit to
- Study type: Interventional
- Planned participants: 72
- From 1 Sept 2026 to the primary completion date, 1 Aug 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with prior exposure to head and neck radiotherapy.
Other illness
- Patients with known allergies or hypersensitivity to dental resin materials.
Other
- Patients who are unable to wear oral stent.
Who the study is looking for
- 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)
Age in the registry: 6 years to 18 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.