RecruitingPhase 2NCT04870762

Customized 3D Printed Oral Stents During Head and Neck Radiotherapy

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


Sponsor

M.D. Anderson Cancer Center

Enrollment

119 participants

Start Date

May 26, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether 3D-printed custom mouth pieces (oral stents) can better protect the tongue and surrounding tissues from radiation damage during head and neck cancer treatment. These custom stents are designed to hold the tongue in a safer position during radiation therapy. **You may be eligible if...** - You are 18 or older and have been diagnosed with a head or neck cancer - You are scheduled to receive 5 to 7 weeks of radiation therapy (with or without chemotherapy) - Your overall health status is acceptable (ECOG score 0–2) - You have signed informed consent **You may NOT be eligible if...** - You have previously received radiation therapy to the head or neck - You cannot physically fit the stent in your mouth (e.g., your mouth opening is less than 10 mm) - You are pregnant - You have significant cognitive impairment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBest Practice

Receive standard of care

OTHERMedical Device Usage and Evaluation

Wear 3D printed oral stent


Locations(7)

Banner Health/Banner Research

Phoenix, Arizona, United States

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

Community MD Anderson Cancer Center East

Indianapolis, Indiana, United States

Community MD Anderson Cancer Center South

Indianapolis, Indiana, United States

Community MD Anderson Cancer Center North

Indianapolis, Indiana, United States

Cooper Hospital University Medical Center

Camden, New Jersey, United States

M D Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT04870762


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