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Custom 3D-Printed stents could spare kids with brain cancer from painful mouth sores

NCT ID NCT07715357

Symptom relief Sponsor: Ain Shams University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 20, 2026 · Last updated Jul 22, 2026 · Updated 2 times

Summary

This trial tests whether custom 3D-printed intraoral stents can protect the mouth from radiation damage in children with medulloblastoma, a type of brain cancer. During radiotherapy, the stent is worn inside the mouth to physically move healthy tissue away from the radiation beam. The study aims to see if this reduces painful mouth sores, gum problems, and cavities, and improves the child's quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
custom-designed 3D-printed intraoral stent made of medical-grade resin
What this could lead to
If effective, this could become a standard way to prevent severe mouth sores in children receiving brain radiation, improving their quality of life during treatment.
What could go wrong
This is a relatively small, early-stage trial, and the benefit may vary depending on each child's anatomy and radiation plan. The stents must be comfortable enough for children to wear daily.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 72 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients who will receive 5-7 weeks of definitive radiotherapy for treatment of a diagnosed medulloblastoma tumor. 2. Age less than 18 years old. 3. No Evidence of oral mucositis at baseline (WHO grade 0) Exclusion Criteria: 1. Patients with prior exposure to head and neck radiotherapy. 2. Patients who are unable to wear oral stent. 3. Patients with known allergies or hypersensitivity to dental resin materials.

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Conditions

The condition(s) this trial relates to.

medulloblastoma mucositis radiation injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Medulloblastoma tumor Mucositis Radiation injuries

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  2. A doctor treating you

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