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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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Best Practice (other)
- Medical Device Usage and Evaluation (other)
Sponsor: M.D. Anderson Cancer Center · Participants: 119 · Started: May 26, 2021
Contact the study team
- Anna Lee, MD · Phone: 932-750-1920
Official record on ClinicalTrials.gov — NCT04870762
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.