Medulloblastoma TumorNCT07715357
Evaluation of The Radioprotective Effect of 3D-Printed Intraoral Stents in Children With Brain Cancer.
A study testing 3D printed intraoral stents. in people with Medulloblastoma Tumor, run by Ain Shams University.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Medulloblastoma Tumor
- What is being tested?
- 3D printed intraoral stents.
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- 3D printed intraoral stents.
- Keywords
- 3D printing, Intraoral stents, Radiation protection, Pediatric Oncology, Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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."
| Study group | Role | What they receive |
|---|---|---|
| 3D printed intraoral stent group | Experimental | Patients will wear the 3D printed intraoral stent during radiotherapy sessions. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Assessments will be carried out weekly during radiotherapy and 3 months after radiotherapy.
Secondary outcomes (2)
Priodontal health status .
Will be assessed using (Löe \& Silness index),Scores range from 0 to 3, where 0 = no plaque and 3 = abundant plaque accumulation. Higher scores indicate poorer oral hygiene (worse outcome).
Measured: Assessment will be carried out weekly during radiotherapy and after 3,6 and 12 months.
Radiation-induced caries
Will be assessed using DMFT index. Scores range from 0 to the maximum number of teeth assessed (e.g., up to 28 permanent teeth excluding third molars, depending on the dentition). Higher scores indicate greater dental caries experience (worse outcome).
Measured: Assessment will be before radiotherapy and 3,6,12 months after radiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Medulloblastoma TumorStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Cancer Hospital Egypt 57357
- Responsible party
- Sponsor
- Investigators
- Nourhan Mahmoud Shahin, MSc, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715357
- Sponsor's protocol ID
- FWA00014377
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25136529Tanem 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.
PubMed 36307656
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07715357
- Acronym / sponsor ID
- FWA00014377
- Conditions
- Medulloblastoma Tumor
- Keywords
- 3D printing, Intraoral stents, Radiation protection, Pediatric Oncology, Radiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Children's Cancer Hospital Egypt 57357
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 3D printed intraoral stent group | Experimental | Device: 3D printed intraoral stents.Patients will wear the 3D printed intraoral stent during radiotherapy sessions. |
| Standard care control group | No intervention | –Patients receiving standard oral care instructions without the use of an intraoral stent (control group). |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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." | Device | 3D printed intraoral stent group |
Primary outcome
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.
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).
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Background: PubMed 25136529Aggarwal 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.
- Background: PubMed 36307656Tanem 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nourhan Mahmoud Shahin, MSc principal investigator
Ain Shams University
Questions about this trial
What is this clinical trial studying?
A study testing 3D printed intraoral stents. in people with Medulloblastoma Tumor, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nourhan Mahmoud Shahin, MSc (+201065717807, Nourhanshahin@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07715357, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.