NCT04870762 · M.D. Anderson Cancer Center
Customized 3D Printed Oral Stents During Head and Neck Radiotherapy
What this study is about
This clinical trial studies the effect of customized 3 dimensional (3D) printed taken by mouth tents on patients with head and neck cancer who are receiving radiotherapy. taken by mouth stents are made from the impression of patients' mouth and cover patients' teeth and gums during radiation therapy.
View original scientific description
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.
Interventions
OTHER
Best Practice
Receive standard of care
OTHER
Medical Device Usage and Evaluation
Wear 3D printed oral stent
Primary outcome measures
Mucositis toxicity rates
Time frame: Through study completion, an average of 1 year
Rate of non-target mucose will be estimated along with the corresponding 95% confidence interval. Cochran-Mantel-Haenszel (CHM) test will be applied to compare mucositis rates between the two treatment arms. Logistic regression will be used to compare occurrence of mucositis between two arms, adjusting for the effects of stratification factors as well as other covariates. T test or Wilcoxon rank sum test will be used to compare three Olerud-Molander Ankle Score between two arms: a mean mucositis score, an extent of mucositis score, and a worst site score.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Phoenix, Arizona
- Jacksonville, Florida
- Indianapolis, Indiana
- Camden, New Jersey
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 15, 2026 · Source of record for eligibility and locations