An official website of the United States government
Customized 3D Printed Oral Stents during Head and Neck Radiotherapy
Trial Status: active
This phase II 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.
Inclusion Criteria
Patient 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
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
The patient will receive either
* radiation alone OR
*radiation with concurrent chemotherapy of any kind(s)
Signed study-specific consent form
Exclusion Criteria
Prior head and neck radiotherapy
Patient 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
Patients younger than 18 years of age
Patients must not be pregnant
Cognitively impaired subjects
Additional locations may be listed on ClinicalTrials.gov for NCT04870762.
