About this trial
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 criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Best Practice
- Medical Device Usage and Evaluation