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

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05126797

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

54.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Malignant Head and Neck Neoplasm	Other: Questionnaire Administration Device: Stent Device	N/A

Detailed Description

PRIMARY OBJECTIVES:

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:

To evaluate the performance of the 3D stent on imaging parameters (i.e. mandibular and soft tissue displacement) for degree of normal tissue sparing.
Evaluate the levels of patient reported outcomes after patients have developed side effects from radiation treatment.
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.

Study Design

Study Type:

Interventional

Actual Enrollment :

57 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 11, 2017

Anticipated Primary Completion Date :

Apr 30, 2022

Anticipated Study Completion Date :

Apr 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: 3D printed stent+ MDASI-3D Oral Stents Questionnaire 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)	Other: Questionnaire Administration Ancillary studies Device: Stent Device Wear customized 3D printed oral stent Other Names: Stent

Arm

Intervention/Treatment

Other: 3D printed stent+ MDASI-3D Oral Stents Questionnaire

Other: Questionnaire Administration

Ancillary studies

Device: Stent Device

Wear customized 3D printed oral stent

Other Names:

Stent

Outcome Measures

Primary Outcome Measures

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. [up to 2 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Investigators

Principal Investigator: Eugene J Koay, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

M.D. Anderson Cancer Center

Publications

None provided.

Responsible Party:

M.D. Anderson Cancer Center

ClinicalTrials.gov Identifier:

NCT05126797

Other Study ID Numbers:

2017-0269
NCI-2019-02460
2017-0269

First Posted:

Nov 19, 2021

Last Update Posted:

Nov 19, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Head and Neck Neoplasms

Study Results

No Results Posted as of Nov 19, 2021