A Randomized Study of Head and Neck Radiotherapy With or Without Customized 3D Printed Oral Stents

  • End date
    Nov 6, 2024
  • participants needed
  • sponsor
    M.D. Anderson Cancer Center
Updated on 23 October 2022


This clinical trial studies the effect of customized 3 dimensional (3D) printed oral tents on patients with head and neck cancer who are receiving radiotherapy. Oral stents are made from the impression of patients' mouth and cover patients' teeth and gums during radiation therapy. A customized, 3D-printed oral stent may help to reduce mouth blisters and/or sores that may develop in patients while receiving head and neck radiation therapy.



I. To evaluate the acute mucositis rates in non-target mucosa of patients who receive head and neck radiation with or without a customized 3D printed oral stent.


I. To record patient reported outcomes during radiotherapy. II. To evaluate patient narcotic use during radiotherapy. III. To evaluate the imaging and dosimetric differences in head and neck radiotherapy with and without a customized 3D printed oral stent.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients wear 3D printed oral stent during standard of care radiotherapy.

ARM II: Patients receive standard of care during treatment.

Condition Head and Neck Carcinoma, Malignant Parotid Gland Neoplasm, Maxillary Sinus Carcinoma, Nasal Cavity Carcinoma, Oral Cavity Carcinoma, Tongue Carcinoma, Tonsillar Carcinoma
Treatment Best Practice, Medical Device Usage and Evaluation
Clinical Study IdentifierNCT04870762
SponsorM.D. Anderson Cancer Center
Last Modified on23 October 2022


Yes No Not Sure

Inclusion Criteria

Patient is dispositioned to receive definitive or adjuvant radiotherapy for treatment of a diagnosed head and neck malignancy that includes
Well lateralized tonsil cancer with no soft palate involvement and qualifies for ipsilateral radiotherapy
Well lateralized buccal cancer that qualifies for ipsilateral radiotherapy
Well lateralized parotid cancer that qualifies for ipsilateral radiotherapy
A cancer that involves the nasal cavity and does not require coverage of the oral cavity or oropharynx
A cancer that involves the maxillary sinus and does not require coverage of the oral cavity or oropharynx
A cancer that involves the base of tongue
Age 18 or older
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
The patient will receive radiotherapy with either cisplatin, carboplatin, or cetuximab
Signed study-specific consent form

Exclusion Criteria

Prior head and neck radiotherapy
Patient 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
Patients younger than 18 years of age
Patients must not be pregnant
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note