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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a 3D-printed oral stent can perform as well as a traditional dentist-made stent for individuals with head and neck cancer undergoing radiation therapy. The researchers aim to determine if the 3D-printed stent can prevent radiation side effects and be prepared more quickly than the conventional method. Individuals with head and neck cancer scheduled for radiation therapy and already possessing a dentist-made stent might be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to explore innovative solutions that could enhance patient care and convenience.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this 3D printed oral stent is safe for use in patients with head and neck cancer?

Research has shown that 3D-printed mouthpieces are generally well-tolerated by patients with head and neck cancer. Studies have found that these mouthpieces can perform as effectively as those made by dentists. Importantly, the reviewed studies did not identify any major side effects associated with 3D-printed mouthpieces.

Previous research has examined their use during radiation therapy. The findings suggest that they fit well and do not cause discomfort or unexpected side effects. These mouthpieces are designed to help reduce the side effects of radiation, providing a significant benefit for patients undergoing treatment.

In summary, the evidence supports the safety of 3D-printed mouthpieces. They offer a comfortable and effective way to manage radiation therapy in head and neck cancer without causing additional health issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 3D printed oral stents for head and neck cancer because they offer a personalized approach to treatment. Unlike traditional stents, which are one-size-fits-all, these stents are custom-made to fit each patient's unique anatomy using 3D printing technology. This precise fit can potentially reduce discomfort and improve the effectiveness of radiation therapy by better protecting healthy tissues from radiation exposure. Additionally, the stents are used at strategic points during radiation therapy, which may enhance the precision of treatment delivery.

What evidence suggests that 3D printed oral stents are effective for head and neck cancer?

Studies have shown that 3D-printed mouthpieces work as well as traditional ones made by dentists for patients with head and neck cancer undergoing radiation therapy. In this trial, participants will use customized 3D-printed oral stents and may also choose to use the commercially-made stent called TruGuard. A recent trial found that these 3D-printed mouthpieces performed similarly to standard ones, like TruGuard, based on patient reports. One advantage of 3D-printed mouthpieces is their faster production, reducing patient wait times. Research also shows they accurately direct radiation to the right areas while protecting healthy tissues, making them a promising option for reducing side effects from radiation treatment. ^{2 3 4 5 6}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12202590/

Comparison of custom-designed oral stents in radiotherapy for ... To compare the 3D-printed oral stents (3D-OS) and personalised hand-made stents in dentistry (DentStent) for head and neck malignancies.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1368837524002628

Development and clinical implementation of a digital ... A prospective trial demonstrated that 3D-printed stents were not inferior to TruGuard and standard stents in terms of patient-reported outcomes (PROs) and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04870762

Customized 3D Printed Oral Stents During Head and Neck ... This clinical trial studies the effect of customized 3 dimensional (3D) printed oral tents on patients with head and neck cancer who are receiving radiotherapy.

4. trial.medpath.com trial.medpath.com/clinical-trial/29d0c45b06d03236/nct04870762-randomized-study-head-neck-radiotherapy-customized-3d-printed-oral-stents

Customized 3D Printed Oral Stents During Head and Neck ... This clinical trial studies the effect of customized 3 dimensional (3D) printed oral tents on patients with head and neck cancer who are receiving ...

5. eurjmedres.biomedcentral.com eurjmedres.biomedcentral.com/articles/10.1186/s40001-023-01333-x

The application of 3D-printed oral stents in intensity ... This study investigates the accuracy of 3D-printed dental stents in intensity-modulated radiotherapy (IMRT) for oropharyngeal cancer (OPC) and their dosimetric ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37909799/

3D printing technology to produce intraoral stents for head ... This study aimed to present a scoping review of studies published on 3D printing of oral stents and their clinical applicability.