Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04870762

Customized 3D Printed Oral Stents During Head and Neck Radiotherapy

Led by M.D. Anderson Cancer Center · Updated on 2026-04-15

119

Participants Needed

7

Research Sites

292 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Customized 3D Printed Oral Stents During Head and Neck Radiotherapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants planned to receive 5 to 7 weeks of definitive or adjuvant radiotherapy for diagnosed head and neck malignancy
  • Age 18 years or older
  • Performance status ECOG 0 to 2
  • Receiving radiation alone or radiation with concurrent chemotherapy
  • Signed study-specific consent form
Not Eligible

You will not qualify if you...

  • Prior head and neck radiotherapy
  • Unable to fit a tongue-lateralizing or tongue-depressing stent
  • Severe trismus with incisal opening less than 10 mm
  • Unable to comply with study procedures
  • Under 18 years of age
  • Pregnant participants
  • Cognitively impaired subjects

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

Banner Health/Banner Research

Phoenix, Arizona, United States, 85234

Actively Recruiting

2

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States, 32207

Actively Recruiting

3

Community MD Anderson Cancer Center East

Indianapolis, Indiana, United States, 46219

Actively Recruiting

4

Community MD Anderson Cancer Center South

Indianapolis, Indiana, United States, 46227

Actively Recruiting

5

Community MD Anderson Cancer Center North

Indianapolis, Indiana, United States, 46250

Actively Recruiting

6

Cooper Hospital University Medical Center

Camden, New Jersey, United States, 08103

Actively Recruiting

7

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

A

Anna Lee, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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