Clinical trial · Interventional
Customized 3D Printed Oral Stents During Head and Neck Radiotherapy
A Randomized Study of Head and Neck Radiotherapy With or Without Customized 3D Printed Oral Stents
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Carcinoma | Head and Neck Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Malignant Parotid Gland Neoplasm | Malignant Parotid Gland Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Maxillary Sinus Carcinoma | Maxillary Sinus Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Nasal Cavity Carcinoma | Nasal Cavity Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Oral Cavity Carcinoma | Oral Cavity Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Tongue Carcinoma | Tongue Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Tonsillar Carcinoma | Tonsillar Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Practice | Other | — | UNRESOLVED |
| Medical Device Usage and Evaluation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (3D printed oral stent)
- description
- Patients wear 3D printed oral stent during standard of care radiotherapy.
- interventionNames
- Other: Best Practice
- Other: Medical Device Usage and Evaluation
- type
- ACTIVE_COMPARATOR
- label
- Arm II (standard of care)
- description
- Patients receive standard of care during treatment.
- interventionNames
- Other: Best Practice
- Other: Medical Device Usage and Evaluation
Primary outcomes (1)
- measure
- Mucositis toxicity rates
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participant is dispositioned to receive 5-7 weeks of definitive or adjuvant radiotherapy for treatment of a diagnosed head and neck malignancy * Age 18 or older * ECOG PS 0-2 * The participant will receive either (a) radiation alone or (b) radiation with concurrent chemotherapy of any kind(s) * Signed study-specific consent form Exclusion Criteria: * Prior head and neck radiotherapy * Participants is unable to fit a tongue-lateralizing or tongue-depressing stent * Severe trismus with an incisal opening of \<10 mm * Inability to comply with the study procedures * Participants younger than 18 years of age * Participants must not be pregnant * Cognitively impaired subjects
References
Publications (0)
Data not yet available