Recruiting
Phase 2

Customized 3D Printed Stents

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT04870762

Conditions

Head and Neck Carcinoma

Malignant Parotid Gland Neoplasm

Maxillary Sinus Carcinoma

Nasal Cavity Carcinoma

Oral Cavity Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Best Practice

Medical Device Usage and Evaluation

Study Details

Brief summary:

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

Head and Neck Carcinoma

Malignant Parotid Gland Neoplasm

Maxillary Sinus Carcinoma

Nasal Cavity Carcinoma

Oral Cavity Carcinoma

Study ID

NCT04870762

Start date

May 26, 2021

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

119 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm I (3D printed oral stent)

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

active comparator: Arm II (standard of care)

Patients receive standard of care during treatment.

Interventions

Best Practice

Receive standard of care

Medical Device Usage and Evaluation

Wear 3D printed oral stent

Primary outcome measure

  • Mucositis toxicity rates [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Anna Lee, MD

932-750-1920alee13@mdanderson.org

Locations

Banner Health/Banner Research

Recruiting

Phoenix, Arizona, United States, 85234

Contacts

Gary V. Walker, MD

480-256-6444gary.walker@bannerhealth.com

Principal Investigator:

Gary V. Walker, MD

Baptist MD Anderson Cancer Center

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

Mark E. Augspurger, MD

904-202-7300mark.augspurger@bmcjax.com

Principal Investigator:

Mark E. Augspurger, MD

Community MD Anderson Cancer Center East

Recruiting

Indianapolis, Indiana, United States, 46219

Contacts

Aleander Augustyn, MD

aaugustyn@ecommunity.com

Principal Investigator:

Alexander Augustyn, MD

Community MD Anderson Cancer Center South

Recruiting

Indianapolis, Indiana, United States, 46227

Contacts

Alexander Augustyn, MD

aaugustyn@ecommunity.com

Principal Investigator:

Alexander Augustyn, MD

Community MD Anderson Cancer Center North

Recruiting

Indianapolis, Indiana, United States, 46250

Contacts

Alexander Augustyn, MD

aaugustyn@ecommunity.com

Principal Investigator:

Alexander Augustyn, MD

Cooper Hospital University Medical Center

Recruiting

Camden, New Jersey, United States, 08103

Contacts

Megan Mezera, MD

856-735-6109mezera-megan@cooperhealth.edu

Principal Investigator:

Megan Mezera, MD

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Ann Lee, MD

932-750-1920alee13@mdanderson.org

Principal Investigator:

Ann Lee, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-04-15.