Clinical Trials Directory

Trials / Recruiting

RecruitingNCT04870762

Customized 3D Printed Oral Stents During Head and Neck Radiotherapy

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

Status
Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
119 (estimated)
Sponsor
M.D. Anderson Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
OTHERBest PracticeReceive standard of care
OTHERMedical Device Usage and EvaluationWear 3D printed oral stent

Timeline

Start date
2021-05-26
Primary completion
2026-12-31
Completion
2026-12-31
First posted
2021-05-03
Last updated
2026-04-15

Locations

7 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04870762. Inclusion in this directory is not an endorsement.