Customized 3D Printed Oral Stents During Head and Neck Radiotherapy
NCT ID: NCT04870762
Last Updated: 2025-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
119 participants
INTERVENTIONAL
2021-05-26
2026-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I (3D printed oral stent)
Patients wear 3D printed oral stent during standard of care radiotherapy.
Best Practice
Receive standard of care
Medical Device Usage and Evaluation
Wear 3D printed oral stent
Arm II (standard of care)
Patients receive standard of care during treatment.
Best Practice
Receive standard of care
Medical Device Usage and Evaluation
Wear 3D printed oral stent
Interventions
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Best Practice
Receive standard of care
Medical Device Usage and Evaluation
Wear 3D printed oral stent
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Anna Lee
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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Banner Health/Banner Research
Phoenix, Arizona, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States
Community MD Anderson Cancer Center East
Indianapolis, Indiana, United States
Community MD Anderson Cancer Center South
Indianapolis, Indiana, United States
Community MD Anderson Cancer Center North
Indianapolis, Indiana, United States
Cooper Hospital University Medical Center
Camden, New Jersey, United States
M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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M D Anderson Cancer Center
Other Identifiers
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NCI-2021-03221
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-1153
Identifier Type: OTHER
Identifier Source: secondary_id
2020-1153
Identifier Type: -
Identifier Source: org_study_id
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