3D Printed Oral Stents for Head and Neck Radiotherapy

This study is looking at whether custom-made 3D printed oral stents can help reduce mouth sores and blisters for people with head and neck cancer who are receiving radiation therapy. These stents are made to fit your mouth and cover your teeth and gums during treatment. You might be eligible if you are 18 or older, have head and neck cancer, and are scheduled to receive 5-7 weeks of radiation therapy, with or without chemotherapy. The study aims to see if using these stents lowers the rate of mucositis (mouth sores) and to understand how they affect your comfort and pain medication use. About 119 people are expected to join this study, but its current status is unclear.

Study design
This interventional study plans to enroll 119 participants and will randomly assign them to either wear a 3D printed oral stent during radiotherapy or receive standard care without the stent.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, mucositis toxicity rates, will be measured through study completion, which is an average of 1 year.

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NCT04870762

Customized 3D Printed Oral Stents During Head and Neck Radiotherapy

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~119 participants
Updated 2026-04-15 on ClinicalTrials.gov
What's tested:Best PracticeMedical Device Usage and Evaluation

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mucositis toxicity rates
Measured over Through study completion, an average of 1 year
Head and Neck Carcinoma
Malignant Parotid Gland Neoplasm
Maxillary Sinus Carcinoma
Nasal Cavity Carcinoma
Oral Cavity Carcinoma
Tongue Carcinoma
Tonsillar Carcinoma
7 sites across 5 states
Indiana3
Arizona1
Florida1
New Jersey1
Texas1
  • Anna Lee · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

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Eligibility criteria

Inclusion

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

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
  • Mucositis toxicity ratesThrough 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.