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Customized 3D Printed Oral Stents During Head and Neck Radiotherapy

NCT04870762 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2026-04-15

No results posted yet for this study

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
  • Tongue Carcinoma
  • Tonsillar Carcinoma

Interventions

OTHER

Best Practice

Receive standard of care

OTHER

Medical Device Usage and Evaluation

Wear 3D printed oral stent

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Anna Lee · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-26
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04870762 on ClinicalTrials.gov