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3D-Printed mouth guards could ease radiation side effects for cancer patients

NCT ID NCT04870762

Symptom relief Sponsor: M.D. Anderson Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether custom 3D-printed oral stents can reduce mouth sores in head and neck cancer patients receiving radiation therapy. The stents are made from a mold of the patient's mouth and cover teeth and gums during treatment. Researchers will compare sore rates and patient-reported symptoms between those who use the stent and those who receive standard care alone.

What this could mean

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

Active substance
customized 3D-printed oral stent
What this could lead to
If it works, this could provide a simple, non-drug way to reduce painful mouth sores during radiation therapy for head and neck cancer.
What could go wrong
This is a mid-stage trial with only 119 participants, so results may not apply to everyone. The stent may not fit all patients or significantly reduce sores compared to standard care.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 119 people

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

Started

May 2021

Expected to finish

Dec 2026

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

18 years and older

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: * Participant is dispositioned to receive 5-7 weeks of definitive or adjuvant radiotherapy for treatment of a diagnosed head and neck malignancy * Age 18 or older * ECOG PS 0-2 * The participant will receive either (a) radiation alone or (b) radiation with concurrent chemotherapy of any kind(s) * Signed study-specific consent form Exclusion Criteria: * Prior head and neck radiotherapy * Participants is unable to fit a tongue-lateralizing or tongue-depressing stent * Severe trismus with an incisal opening of \<10 mm * Inability to comply with the study procedures * Participants younger than 18 years of age * Participants must not be pregnant * Cognitively impaired subjects

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Conditions

The condition(s) this trial relates to.

head and neck carcinoma maxillary sinus carcinoma maxillary sinus neoplasm Mouth Neoplasms nasal cavity carcinoma oral cavity carcinoma parotid gland cancer tongue cancer tongue carcinoma tonsil cancer tonsil carcinoma

As listed by the trial registrant

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

Head and neck carcinoma Malignant parotid gland neoplasm Maxillary sinus carcinoma Nasal cavity carcinoma Oral cavity carcinoma Tongue carcinoma Tonsillar carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

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

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Banner Health/Banner Research

    RECRUITING

    Phoenix, Arizona, 85234, United States

  • Baptist MD Anderson Cancer Center

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • Community MD Anderson Cancer Center East

    RECRUITING

    Indianapolis, Indiana, 46219, United States

  • Community MD Anderson Cancer Center North

    RECRUITING

    Indianapolis, Indiana, 46250, United States

  • Community MD Anderson Cancer Center South

    RECRUITING

    Indianapolis, Indiana, 46227, United States

  • Cooper Hospital University Medical Center

    RECRUITING

    Camden, New Jersey, 08103, United States

  • M D Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

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