Customized 3D Printed Oral Stents During Head and Neck Radiotherapy

April 10, 2026 updated by: M.D. Anderson Cancer Center

A Randomized Study of Head and Neck Radiotherapy With or Without Customized 3D Printed Oral Stents

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate the acute mucositis rates in non-target mucosa of patients who receive head and neck radiation with or without a customized 3D printed oral stent.

SECONDARY OBJECTIVES:

I. To record patient reported outcomes during radiotherapy. II. To evaluate patient narcotic use during radiotherapy. III. To evaluate the imaging and dosimetric differences in head and neck radiotherapy with and without a customized 3D printed oral stent.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients wear 3D printed oral stent during standard of care radiotherapy.

ARM II: Patients receive standard of care during treatment.

Study Type

Interventional

Enrollment (Estimated)

119

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85234
        • Recruiting
        • Banner Health/Banner Research
        • Contact:
        • Principal Investigator:
          • Gary V. Walker, MD
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist MD Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Mark E. Augspurger, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46219
        • Recruiting
        • Community MD Anderson Cancer Center East
        • Contact:
        • Principal Investigator:
          • Alexander Augustyn, MD
      • Indianapolis, Indiana, United States, 46227
        • Recruiting
        • Community MD Anderson Cancer Center South
        • Principal Investigator:
          • Alexander Augustyn, MD
        • Contact:
      • Indianapolis, Indiana, United States, 46250
        • Recruiting
        • Community MD Anderson Cancer Center North
        • Principal Investigator:
          • Alexander Augustyn, MD
        • Contact:
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Recruiting
        • Cooper Hospital University Medical Center
        • Contact:
        • Principal Investigator:
          • Megan Mezera, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Ann Lee, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (3D printed oral stent)
Patients wear 3D printed oral stent during standard of care radiotherapy.
Other: Best Practice
Receive standard of care
Other Names:
  • standard of care
  • standard therapy
Other: Medical Device Usage and Evaluation
Wear 3D printed oral stent
Active Comparator: Arm II (standard of care)
Patients receive standard of care during treatment.
Other: Best Practice
Receive standard of care
Other Names:
  • standard of care
  • standard therapy
Other: Medical Device Usage and Evaluation
Wear 3D printed oral stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient reported outcomes
Time Frame: Through study completion, an average of 1 year
Will be assessed using the MD Anderson Symptom Inventory Head and Neck questionnaire. T test or Wilcoxon rank sum test will be used to compare scores of each item per time point or sums of scores across all items at each time point or sums across three time point per item between the two arms. Multivariate analyses such as linear regression model adjusting for the effects of covariates might be performed to compare patients reported outcomes. Appropriate data transformation will be performed if necessary for assumption of normality.
Through study completion, an average of 1 year
Patients narcotics diaries
Time Frame: Through study completion, an average of 1 year
Will record the worst, the least, the average pain score and pain score at present for each day. Will calculate the average of these 4 scores as a composite daily pain score.
Through study completion, an average of 1 year
Imaging difference
Time Frame: Through study completion, an average of 1 year
The set up error during radiation will be measured in each treatment arm.
Through study completion, an average of 1 year
Dosimetric difference
Time Frame: Through study completion, an average of 1 year
The radiation dose to healthy tissue will be measured in each treatment arm.
Through study completion, an average of 1 year
Composite pain scores
Time Frame: Through study completion, an average of 1 year
An area under curve of pain scores over two weeks (AUC2wks) will be calculated for each patient, and the t test or Wilcoxon rank sum test will be used to compare the AUC2wks of pain scores between the two arms, and between patients with and without occurrence of mucositis in their non-target mucosa. Will also fit linear mixed models including patients as random effects to compare the composite pain scores over two weeks between treatment arms. The linear mixed models will also be fitted to evaluate the association of composite pain scores with occurrence of their non-target mucosa.
Through study completion, an average of 1 year
Number of narcotic pills used
Time Frame: Through study completion, an average of 1 year
An AUC2wks will be calculated for each patient, and the t test or Wilcoxon rank sum test will be used to compare the AUC2wks of pain scores between the two arms, and between patients with and without occurrence of mucositis in their non-target mucosa. Will also fit linear mixed models including patients as random effects to compare the composite pain scores over two weeks between treatment arms.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Anna Lee, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 23, 2021

First Submitted That Met QC Criteria

April 30, 2021

First Posted (Actual)

May 3, 2021

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-1153 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2021-03221 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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