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

NCT05126797 | Terminated FDA Device

• 2 other identifiers: 2017-0269NCI-2019-02460
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

3D printed stent+ MDASI-3D Oral Stents Questionnaire

OTHER

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; Device: Stent Device

Interventions

Questionnaire Administration OTHER

Ancillary studies

3D printed stent+ MDASI-3D Oral Stents Questionnaire

Stent Device DEVICE

Wear customized 3D printed oral stent

Also known as: Stent

3D printed stent+ MDASI-3D Oral Stents Questionnaire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M.D. Anderson Cancer Center

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Stents

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Eugene J Koay

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: November 19, 2021
• Study Start: October 11, 2017
• Primary Completion: March 21, 2025
• Study Completion: March 21, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

US (1)