NCT05126797

3D Printed Oral Stents for Patients With Head and Neck Cancer Receiving Radiation Therapy

3D Printed Oral Stents for Patients Receiving Head and Neck Radiation Therapy

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial studies how a customized 3D-printed oral stent compares to a standard stent made by a dentist for use in imaging scans in patients with head and neck cancer receiving radiation therapy. Oral stents are designed to help prevent radiation-related side effects while receiving radiation therapy. Traditional oral stents are created by dentists, require at least 2 separate appointments, and may not be as cost-effective. A customized, 3D-printed oral stent may perform as well as a standard stent made by a dentist and have a significantly shorter turnaround to device delivery.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate whether a customized 3 dimensional (3D) printed oral stent achieves non-inferior levels of patient reported outcomes as the standard dental-fabricated oral stents at the time prior to starting treatment. SECONDARY OBJECTIVES: I. To evaluate the performance of the 3D stent on imaging parameters (i.e. mandibular and soft tissue displacement) for degree of normal tissue sparing. II. Evaluate the levels of patient reported outcomes after patients have developed side effects from radiation treatment. III. To evaluate the commercially available TruGuard oral cavity positioning system. OUTLINE: Patients wear a customized 3D printed oral stent over 5-10 minutes in the supine position at the time of radiation simulation, before starting radiation therapy, and in the 3rd to 5th week of radiation therapy. Patients may also optionally wear the commercially-made stent called TruGuard at these timepoints.

Conditions

• Malignant Head and Neck Neoplasm

Interventions

Type	Name	Description
OTHER	Questionnaire Administration	Ancillary studies
DEVICE	Stent Device	Wear customized 3D printed oral stent

Timeline

• Start date: 2017-10-11
• Primary completion: 2025-03-21
• Completion: 2025-03-21
• First posted: 2021-11-19
• Last updated: 2025-03-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study