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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Customized 3D Printed Oral Stents During Head and Neck Radiotherapy
At a glance
Conditions
Where it's being run
7 sites across 5 statesStudy leadership
- Anna Lee · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- 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.