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

Trial Summary

What is the purpose of this trial?

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. Oral stents are made from the impression of patients' mouth and cover patients' teeth and gums during radiation therapy. A customized, 3D-printed oral stent may help to reduce mouth blisters and/or sores that may develop in patients while receiving head and neck radiation therapy.

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 data supports the effectiveness of the treatment Customized 3D Printed Oral Stents for head and neck cancers?

Research shows that 3D printed oral stents can protect healthy tissues during radiotherapy for head and neck cancers, reducing radiation exposure to sensitive areas by significant percentages. This suggests they are effective in minimizing side effects and improving treatment precision. ^{1 2 3 4 5}

Is the 3D printed oral stent safe for use in humans?

Research shows that 3D printed oral stents have been used safely in patients undergoing radiotherapy for head and neck cancers, with studies indicating they help protect normal tissues and reduce side effects. ^{1 2 3 4 6}

How is the 3D printed oral stent treatment for head and neck cancers different from other treatments?

The 3D printed oral stent is unique because it is custom-made for each patient using 3D scanning and printing technology, which helps protect healthy tissues during radiotherapy by precisely positioning the mouth and tongue. This approach is different from traditional methods that use wax stents, as it offers a more personalized fit and potentially reduces side effects by minimizing radiation exposure to non-target areas. ^{1 2 3 4 5}

Research Team

Anna Lee

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Creating customized oral stents for head and neck radiotherapy using 3D scanning and printing. [2021]

2. England 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. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Dosimetric evaluation of a patient-specific 3D-printed oral positioning stent for head-and-neck radiotherapy. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Wearing individualized 3D printed oral stent to protect normal tissues in patients with nasopharyngeal carcinoma during radiotherapy. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Digital Workflow for Producing Oral Positioning Radiotherapy Stents for Head and Neck Cancer. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Development of a customisable 3D-printed intra-oral stent for head-and-neck radiotherapy. [2022]