MedTrace Logo

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

NCT05126797 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2025-03-26

No results posted yet for this study

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.

Conditions

  • Malignant Head and Neck Neoplasm

Interventions

OTHER

Questionnaire Administration

Ancillary studies

DEVICE

Stent Device

Wear customized 3D printed oral stent

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Eugene J Koay · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-11
Primary Completion
2025-03-21
Completion
2025-03-21
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05126797 on ClinicalTrials.gov