Clinical trial · Interventional
3D Printed Oral Stents for Patients With Head and Neck Cancer Receiving Radiation Therapy
3D Printed Oral Stents for Patients Receiving Head and Neck Radiation Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Administrativley Complete, \<75% Participants
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Head and Neck Neoplasm | Malignant Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaire Administration | Other | — | UNRESOLVED |
| Stent Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- 3D printed stent+ MDASI-3D Oral Stents Questionnaire
- description
- 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)
- interventionNames
- Other: Questionnaire Administration
- Device: Stent Device
Primary outcomes (1)
- measure
- 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.
- timeFrame
- up to 2 months
- description
- 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
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available