Customized 3D Printed Oral Stents During Head and Neck Radiotherapy

Recruiting now · Phase 2

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

In brief

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.

Key facts

Study ID

NCT04870762

Run by

M.D. Anderson Cancer Center

People needed

119

Starts

2021-05-26

Expected to finish

2026-12-31

Last updated by the study team

2026-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Banner Health/Banner Research — Phoenix, Arizona, United States (enrolling)
• Baptist MD Anderson Cancer Center — Jacksonville, Florida, United States (enrolling)
• Community MD Anderson Cancer Center East — Indianapolis, Indiana, United States (enrolling)
• Community MD Anderson Cancer Center South — Indianapolis, Indiana, United States (enrolling)
• Community MD Anderson Cancer Center North — Indianapolis, Indiana, United States (enrolling)
• Cooper Hospital University Medical Center — Camden, New Jersey, United States (enrolling)
• M D Anderson Cancer Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.