Customized 3D Printed Oral Stents During Head and Neck Radiotherapy

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT04870762
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Head and Neck Carcinoma
  • Malignant Parotid Gland Neoplasm
  • Maxillary Sinus Carcinoma
  • Nasal Cavity Carcinoma
  • Oral Cavity Carcinoma
  • Tongue Carcinoma
  • Tonsillar Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Best Practice — OTHER
    Receive standard of care
  • Medical Device Usage and Evaluation — OTHER
    Wear 3D printed oral stent

Study Details

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.

Key Dates

Start date
May 26, 2021
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
119 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Banner Health/Banner ResearchPhoenixArizona85234
Gary V. Walker, MD
[email protected]
480-256-6444
Gary V. Walker, MD (PRINCIPAL_INVESTIGATOR)
Baptist MD Anderson Cancer CenterJacksonvilleFlorida32207
Mark E. Augspurger, MD
[email protected]
904-202-7300
Mark E. Augspurger, MD (PRINCIPAL_INVESTIGATOR)
Community MD Anderson Cancer Center EastIndianapolisIndiana46219
Aleander Augustyn, MD
[email protected]
Alexander Augustyn, MD (PRINCIPAL_INVESTIGATOR)
Community MD Anderson Cancer Center NorthIndianapolisIndiana46250
Alexander Augustyn, MD
[email protected]
Alexander Augustyn, MD (PRINCIPAL_INVESTIGATOR)
Community MD Anderson Cancer Center SouthIndianapolisIndiana46227
Alexander Augustyn, MD
[email protected]
Alexander Augustyn, MD (PRINCIPAL_INVESTIGATOR)
Cooper Hospital University Medical CenterCamdenNew Jersey08103
Megan Mezera, MD
[email protected]
856-735-6109
Megan Mezera, MD (PRINCIPAL_INVESTIGATOR)
M D Anderson Cancer CenterHoustonTexas77030
Ann Lee, MD
[email protected]
932-750-1920
Ann Lee, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Banner Health/Banner Research· Phoenix, AZBaptist MD Anderson Cancer Center· Jacksonville, FLCommunity MD Anderson Cancer Center East· Indianapolis, INCommunity MD Anderson Cancer Center North· Indianapolis, INCommunity MD Anderson Cancer Center South· Indianapolis, INCooper Hospital University Medical Center· Camden, NJ

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