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

Malignant Head and Neck Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05126797
• Other study ID #: 2017-0269
• Secondary ID: NCI-2019-0246020
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 11, 2017
• Est. completion date: October 30, 2024

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

PRIMARY OBJECTIVES:

I. 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.

SECONDARY OBJECTIVES:

I. To evaluate the performance of the 3D stent on imaging parameters (i.e. mandibular and soft tissue displacement) for degree of normal tissue sparing.

II. Evaluate the levels of patient reported outcomes after patients have developed side effects from radiation treatment.

III. To evaluate the commercially available TruGuard oral cavity positioning system.

OUTLINE:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 57
• Est. completion date: October 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Malignant Head and Neck Neoplasm

Intervention

Other:
• Questionnaire Administration
Ancillary studies

Device:
• Stent Device
Wear customized 3D printed oral stent

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   M.D. Anderson Cancer Center