Randomized Phase 2 Study of Head and Neck Radiotherapy With or Without Customized 3D Printed Oral Stents

What this Trial Is About

Researchers are evaluating the effect of customized three-dimensional 3D printed oral stents in patients with head and neck cancers who are undergoing radiotherapy. The study aims to compare rates of mouth sores, called mucositis, in areas not targeted by radiation between patients who use these oral stents and those who receive standard care. This phase 2 trial also looks at patient-reported experiences, narcotic pain medication use, and imaging and radiation dose differences during treatment. Participants are randomly assigned to one of two groups. One group wears a customized 3D printed oral stent that fits over their teeth and gums during standard radiotherapy, while the other group receives only the standard radiotherapy without the stent. The oral stent is created from a mold of each patients mouth and is designed to protect oral tissues during treatment. During the study, participants are monitored throughout their radiotherapy course, which lasts 5 to 7 weeks. Researchers collect data on mouth soreness, pain scores, narcotic use, and imaging studies to evaluate radiation effects. These outcomes are tracked for up to one year after treatment to assess the longer-term impact. Participants complete diaries and patient-reported outcome measures to provide detailed information on their symptoms and medication use.

Customized 3D Printed Oral Stents During Head and Neck Radiotherapy