Customized 3D Printed Oral Stents During Head and Neck Radiotherapy

Description

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.

Conditions

Head and Neck Carcinoma, Malignant Parotid Gland Neoplasm, Maxillary Sinus Carcinoma, Nasal Cavity Carcinoma, Oral Cavity Carcinoma, Tongue Carcinoma, Tonsillar Carcinoma

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Study Overview

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Study Details

Study overview

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.

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

Customized 3D Printed Oral Stents During Head and Neck Radiotherapy

Condition
Head and Neck Carcinoma
Intervention / Treatment

-

Contacts and Locations

Phoenix

Banner Health/Banner Research, Phoenix, Arizona, United States, 85234

Jacksonville

Baptist MD Anderson Cancer Center, Jacksonville, Florida, United States, 32207

Camden

Cooper Hospital University Medical Center, Camden, New Jersey, United States, 08103

Houston

M D Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

M.D. Anderson Cancer Center,

Anna Lee, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

2026-12-31