Actively Recruiting
Customized 3D Printed Oral Stents During Head and Neck Radiotherapy
Led by M.D. Anderson Cancer Center · Updated on 2026-04-15
119
Participants Needed
7
Research Sites
292 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Customized 3D Printed Oral Stents During Head and Neck Radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants planned to receive 5 to 7 weeks of definitive or adjuvant radiotherapy for diagnosed head and neck malignancy
- Age 18 years or older
- Performance status ECOG 0 to 2
- Receiving radiation alone or radiation with concurrent chemotherapy
- Signed study-specific consent form
You will not qualify if you...
- Prior head and neck radiotherapy
- Unable to fit a tongue-lateralizing or tongue-depressing stent
- Severe trismus with incisal opening less than 10 mm
- Unable to comply with study procedures
- Under 18 years of age
- Pregnant participants
- Cognitively impaired subjects
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Banner Health/Banner Research
Phoenix, Arizona, United States, 85234
Actively Recruiting
2
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States, 32207
Actively Recruiting
3
Community MD Anderson Cancer Center East
Indianapolis, Indiana, United States, 46219
Actively Recruiting
4
Community MD Anderson Cancer Center South
Indianapolis, Indiana, United States, 46227
Actively Recruiting
5
Community MD Anderson Cancer Center North
Indianapolis, Indiana, United States, 46250
Actively Recruiting
6
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
Actively Recruiting
7
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Anna Lee, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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