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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-11

Study Completion Date

2025-03-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Malignant Head and Neck Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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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)

Group Type OTHER

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Stent Device

Intervention Type DEVICE

Wear customized 3D printed oral stent

Interventions

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Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Stent Device

Wear customized 3D printed oral stent

Intervention Type DEVICE

Other Intervention Names

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Stent

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No