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NCT04870762 · ClinicalTrials.gov registry record · Phase 2
Customized 3D Printed Oral Stents During Head and Neck Radiotherapy
A Phase 2 study of Head and Neck Carcinoma and Oral Cavity Carcinoma, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 119
- Enrollment target
- 7
- Study locations
NCT04870762: Recruiting Phase 2 study of Head and Neck Carcinoma and Oral Cavity Carcinoma, sponsored by M.D. Anderson Cancer Center.
NCT04870762 is a Phase 2 study of Head and Neck Carcinoma and Oral Cavity Carcinoma that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 119 participants, below the 409-participant average among 30 other Head and Neck Carcinoma trials with a reported enrollment target (71% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04870762, a Phase 2 study of Head and Neck Carcinoma and Oral Cavity Carcinoma, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 119 participants
- Enrollment target
- 7
- Study locations
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.
Primary Outcome
Rate of non-target mucose will be estimated along with the corresponding 95% confidence interval. Cochran-Mantel-Haenszel (CHM) test will be applied to compare mucositis rates between the two treatment arms. Logistic regression will be used to compare occurrence of mucositis between two arms, adjusting for the effects of stratification factors as well as other covariates. T test or Wilcoxon rank sum test will be used to compare three Olerud-Molander Ankle Score between two arms: a mean mucositis
Conditions Studied
Interventions
- OTHER Medical Device Usage and Evaluation
- OTHER Best Practice
Study Locations (7)
Indiana
- Community MD Anderson Cancer Center East - Indianapolis
- Community MD Anderson Cancer Center South - Indianapolis
- Community MD Anderson Cancer Center North - Indianapolis
Arizona
- Banner Health/Banner Research - Phoenix
Florida
- Baptist MD Anderson Cancer Center - Jacksonville
New Jersey
- Cooper Hospital University Medical Center - Camden
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2021-05-26 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What NCT04870762 shows while recruiting
NCT04870762 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 409-participant average among 30 other Head and Neck Carcinoma trials with a reported enrollment target (71% lower).
The record links to 7 conditions, with Head and Neck Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Medical Device Usage and Evaluation is the first listed.
NCT04870762 lists 7 locations in 5 states (Indiana, Arizona, Florida).
Frequently Asked Questions
What is clinical trial NCT04870762 about?
NCT04870762 is a clinical study titled "Customized 3D Printed Oral Stents During Head and Neck Radiotherapy". 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-p...
What is the current status of trial NCT04870762?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 119 participants. The study started on 2021-05-26. Estimated completion is 2026-12-31.
What conditions does trial NCT04870762 study?
This clinical trial studies the following conditions: Head and Neck Carcinoma, Oral Cavity Carcinoma, Nasal Cavity Carcinoma, Maxillary Sinus Carcinoma, Tongue Carcinoma.
What interventions are being tested in trial NCT04870762?
The interventions under investigation include: Medical Device Usage and Evaluation (OTHER), Best Practice (OTHER).
Who is sponsoring clinical trial NCT04870762?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04870762 being conducted?
This trial has 7 study locations across Arizona, Florida, Indiana, New Jersey, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Head and Neck Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04870762's enrollment target sits among peer trials
119 11th of 30 higher than 20 of 30 other Head and Neck Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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