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

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.

Study Overview

• Status: Terminated
• Conditions: Malignant Head and Neck Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Device: Stent Device

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.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient is dispositioned to receive definitive or adjuvant radiotherapy for treatment of a diagnosed head and neck malignancy.
• Treating radiation oncologist has determined the necessity of an oral stent and a device has been fabricated by dentistry at MD Anderson Cancer Center (MDACC).
• Patient has received pre-treatment imaging which includes the mandibular and maxillary dentition.
• Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.
• Signed study-specific consent form.

Exclusion Criteria:

• No pre-treatment computed tomography (CT) imaging including the maxilla and mandible is available.
• Prior head and neck radiotherapy.
• Severe trismus with an incisal opening of < 10 mm.
• Inability to comply with the study procedures.
• Patients who have received dental stents fabricated outside of MDACC.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 3D printed stent+ MDASI-3D Oral Stents Questionnaire; 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. Ancillary Studies (MDASI-3D Oral Stents Questionnaire)

Other: Questionnaire Administration; Ancillary studies; Device: Stent Device; Wear customized 3D printed oral stent; Other Names: Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The patient will fill out a questionnaire that measures the form and fit of the 3D printed oral stent at specified time points, and this measurement will be compared with a standard stent. Score ranges(0-10) 0 None at all-10 As bad as you can imagine.	up to 2 months

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Eugene J Koay, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M.D. Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2017
• Primary Completion (Actual): March 21, 2025
• Study Completion (Actual): March 21, 2025

Study Registration Dates

• First Submitted: September 3, 2021
• First Submitted That Met QC Criteria: November 16, 2021
• First Posted (Actual): November 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: 2017-0269 (Other Identifier: M D Anderson Cancer Center); NCI-2019-02460 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No