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

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.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the acute mucositis rates in non-target mucosa of patients who receive head and neck radiation with or without a customized 3D printed oral stent. SECONDARY OBJECTIVES: I. To record patient reported outcomes during radiotherapy. II. To evaluate patient narcotic use during radiotherapy. III. To evaluate the imaging and dosimetric differences in head and neck radiotherapy with and without a customized 3D printed oral stent. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients wear 3D printed oral stent during standard of care radiotherapy. ARM II: Patients receive standard of care during treatment.

Arms & interventions

• OtherBest Practice

  Receive standard of care

• OtherMedical Device Usage and Evaluation

  Wear 3D printed oral stent

Outcome measures

Eligibility criteria