3D Printed Stents for Head and Neck Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Prior head and neck radiotherapy, severe trismus, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

57 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Eugene J. Koay

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with head and neck cancer who need an oral stent as part of their radiation therapy. They must be treated at MD Anderson Cancer Center, have a performance status score of 0-2, consent to the study, and have pre-treatment imaging that includes their teeth. Patients with prior head and neck radiotherapy or severe trismus are excluded.

Inclusion Criteria

Signed study-specific consent form

I am able to get out of my bed or chair and move around.

I am set to receive radiotherapy for my head or neck cancer.

Exclusion Criteria

Patients who have received dental stents fabricated outside of MDACC

I can barely open my mouth (less than 10mm).

I have had radiotherapy for head or neck cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Simulation

Participants wear a customized 3D printed oral stent during radiation simulation

1 day

1 visit (in-person)

Radiation Therapy

Participants receive radiation therapy while wearing the 3D printed oral stent

3-5 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 2 months

What Are the Treatments Tested in This Trial?

Interventions

• 3D Printed Oral Stents

Trial Overview The trial is testing a customized 3D-printed oral stent against traditional dentist-made stents in patients receiving radiation therapy for head and neck cancer. The focus is on comparing effectiveness in preventing side effects and efficiency in turnaround time for device delivery.

How Is the Trial Designed?

Group I: 3D printed stent+ MDASI-3D Oral Stents Questionnaire Experimental Treatment 2 Interventions

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)

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+