3D Printed Oral Stents for Head and Neck Cancers

Recruiting at 6 trial locations

Overseen By Anna Lee, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

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)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

119 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of customized 3D-printed oral stents for individuals with head and neck cancer undergoing radiation therapy. These stents, tailored to fit each person's mouth, aim to protect teeth and gums, potentially reducing painful mouth blisters or sores during treatment. The trial includes two groups: one will use the 3D-printed stent during radiation therapy, while the other will receive standard care without the stent. Suitable participants have been diagnosed with head and neck cancer and are scheduled for 5-7 weeks of radiation therapy. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves radiation therapy, it's best to discuss your current medications with the study team to ensure there are no interactions.

What prior data suggests that these 3D printed oral stents are safe for patients with head and neck cancer?

Research has shown that custom-made 3D printed mouthpieces are generally well-accepted by patients. In earlier studies, researchers compared these mouthpieces to traditional options like TruGuard and standard mouthpieces. The results indicated that 3D printed mouthpieces performed equally well, with users reporting no more problems or discomfort than those using other types.

Another study found that these mouthpieces provide stable support during treatment and integrate well into the usual care process, suggesting they are easy and safe to use. Patients did not report any major side effects, indicating no serious issues commonly linked to their use.

Overall, the evidence suggests that 3D printed mouthpieces are safe for use during head and neck cancer treatments, with no major safety concerns reported in the available studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about customized 3D printed oral stents for head and neck cancer treatment because they offer a new way to enhance the effectiveness of radiotherapy. Unlike traditional treatments, which often involve standard care without personalized support, these stents are designed to fit each patient's unique anatomy. This precise fit helps protect healthy tissue during radiation, potentially reducing side effects and improving outcomes. The innovation lies in the stent's ability to deliver targeted support, which could make cancer treatment more comfortable and effective for patients.

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

In this trial, participants in one arm will use 3D-printed oral stents during their standard radiotherapy. Studies have shown that 3D-printed mouthpieces can benefit individuals undergoing radiation therapy for head and neck cancer. Research indicates that these mouthpieces protect the mouth by covering the teeth and gums, reducing the risk of blisters and sores. One study found that 3D-printed mouthpieces were as effective as traditional ones, with patients reporting similar positive experiences. Another study noted that these custom-made 3D-printed mouthpieces fit well and integrate smoothly with standard treatment procedures. The aim is to make radiation therapy more comfortable and potentially improve treatment outcomes by reducing side effects in the mouth. ^{1 2 3 5 6}

Who Is on the Research Team?

Anna Lee

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with specific head and neck cancers, including those affecting the tongue, nasal cavity, maxillary sinus, tonsils, buccal region or parotid gland. Participants must be receiving radiotherapy with cisplatin, carboplatin or cetuximab and have a performance status that allows daily activities. Those who've had prior head and neck radiation or can't use oral stents due to severe mouth opening limitations are excluded.

Inclusion Criteria

I will be treated with radiotherapy and either cisplatin, carboplatin, or cetuximab.

- Signed study-specific consent form

My cancer is in the maxillary sinus and doesn't affect my mouth or throat.

Exclusion Criteria

Patient is unable to fit a tongue-lateralizing or tongue-depressing stent

Inability to comply with the study procedures

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

Radiotherapy

Participants receive head and neck radiotherapy with or without a customized 3D printed oral stent

Approximately 6-8 weeks

Weekly visits for radiotherapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including mucositis rates and pain scores

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Customized 3D Printed Oral Stents

Trial Overview The study evaluates customized 3D-printed oral stents in patients undergoing radiotherapy for head and neck cancer. These personalized devices aim to protect teeth and gums during treatment potentially reducing mouth sores caused by radiation.

How Is the Trial Designed?

Group I: Arm I (3D printed oral stent) Experimental Treatment 2 Interventions

Patients wear 3D printed oral stent during standard of care radiotherapy.

Group II: Arm II (standard of care) Active Control 2 Interventions

Patients receive standard of care during treatment.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

The study successfully demonstrated that 3D printed oral positioning stents made from food-safe polylactic acid (PLA+) can effectively replace traditional wax stents in head-and-neck radiotherapy, ensuring proper positioning of intra-oral anatomy during treatment.

Both the 3D printed and wax stents were effective in displacing sensitive oral tissues away from radiation targets, with dosimetric tests confirming the accuracy of dose calculations, suggesting that 3D printing could be a viable and innovative alternative for creating these stents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric evaluation of a patient-specific 3D-printed oral positioning stent for head-and-neck radiotherapy. Cleland, S., Chan, P., Chua, B., et al.[2021]

The study demonstrates that a 3D-printed oral positioning radiotherapy stent can effectively protect healthy tissues during head and neck radiotherapy, significantly reducing radiation exposure to critical areas such as the hard palate and parotid glands.

Using the stent resulted in a reduction of radiation doses by 42% to the planning target volume, 21% to the right parotid gland, and 8.5% to the left parotid gland, indicating its efficacy in minimizing side effects for patients undergoing treatment for squamous cell carcinoma of the tongue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Workflow for Producing Oral Positioning Radiotherapy Stents for Head and Neck Cancer. Bruno, JS., Miranda-Silva, W., Guedes, VDS., et al.[2022]

The use of an individualized 3D printed oral stent in radiotherapy for nasopharyngeal carcinoma (NPC) patients significantly reduced radiation exposure to oral tissues, with notable decreases in maximum and mean doses to the tongue and periglottis, which can help minimize adverse reactions.

This study involved 30 NPC patients and demonstrated that the stent not only protects sensitive oral structures during treatment but also has the potential to improve patient compliance and quality of life during radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearing individualized 3D printed oral stent to protect normal tissues in patients with nasopharyngeal carcinoma during radiotherapy. Yang, W., Yang, Z., Pan, W., et al.[2023]

In a study involving 41 patients with head and neck cancers, 3D-printed mouth-opening-tongue-depressing stents (MOTDs) showed significantly better patient-reported outcomes compared to traditional wax and standard stents, indicating improved comfort and usability.

The 3D-printed MOTDs were found to be non-inferior to the commercially available TruGuard stents, with a much faster production time of 8 hours compared to 48 hours for standard stents, suggesting a more efficient option for patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective parallel design study testing non-inferiority of customized oral stents made using 3D printing or manually fabricated methods. Zaid, M., Koay, EJ., Bajaj, N., et al.[2021]

The study established a digital workflow for creating custom 3D-printed mouth opening tongue-depressing (MOTD) stents for head and neck cancer patients undergoing radiotherapy, showing a significant time efficiency improvement of over 60% compared to traditional CT scanning methods.

The 3D scanning method not only reduced time but also provided higher accuracy and reproducibility in stent design, making it a superior option for creating these devices, which can help expand their use in radiation oncology practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creating customized oral stents for head and neck radiotherapy using 3D scanning and printing. Zaid, M., Bajaj, N., Burrows, H., et al.[2021]

A custom 3D printed intra-oral stent was developed to help protect non-involved oral tissues during radiotherapy for head-and-neck cancer, showing potential to reduce radiation side effects.

An MRI study on a healthy participant indicated that the stent effectively displaces oral tissues and is comfortable, suggesting its practical application in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a customisable 3D-printed intra-oral stent for head-and-neck radiotherapy. Cleland, S., Crowe, SB., Chan, P., et al.[2022]

Citations

1. 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9260300/

Development of a customisable 3D-printed intra-oral stent for ... New modular 3D printed stents provide stable displacement. Modular stents achieve positive outcomes within standard treatment workflow.

3. 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 ...

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. frontiersin.org frontiersin.org/journals/bioengineering-and-biotechnology/articles/10.3389/fbioe.2025.1544105/full

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

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.