Customized 3D Printed Oral Stents During Head and Neck Radiotherapy

StatusActive, Not Recruiting
PhasePhase 2
Started

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Record History

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  1. Enrollment closed, study ongoing Show 4 more changesShow less
    • Final enrollment: 88 participants (planned 119)
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 4 of 6 entries
    • Site details revised at 7 of 7 sites
  2. 2 versions Re-verified since Oct 7, 2025, no change to tracked fieldsv15-v16
  3. Study sites: 4 to 7v14
  4. Re-verified, no change to tracked fieldsv13
  5. Primary and study completion dates: Nov 6, 2024 to Dec 31, 2026
    • Enrollment target: 93 to 119
    • Eligibility criteria shortened, about 73 words
    • Site contacts updated at 1 of 4 sites
    v12
Show 10 earlier versionsHide 10 earlier versions
  1. Re-verified, no change to tracked fieldsv11
  2. Site details revised at 2 of 4 sitesv10
  3. Site details revised at 1 of 4 sitesv9
  4. Phase: Not applicable to Phase 2v8
  5. Site details revised at 2 of 4 sitesv7
  6. Site contacts updated at 1 of 4 sitesv6
  7. Re-verified, no change to tracked fieldsv5
  8. Study sites: 1 to 4
    • Interventions: Best Practice (Other), Medical Device Usage and Evaluation (Device) to Best Practice (Other), Medical Device Usage and Evaluation (Other)
    • Secondary endpoints: details revised at 6 of 6 entries
    v4
  9. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 1, 2021 to May 26, 2021
    • Site details revised
    v3
  10. Interventions: Best Practice (Other), Medical Device Usage and Evaluation (Other) to Best Practice (Other), Medical Device Usage and Evaluation (Device)
    • Secondary endpoints: details revised at 2 of 6 entries
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04870762
Lead Sponsor M.D. Anderson Cancer Center
Conditions
(from sponsor)		 Head and Neck Carcinoma, Malignant Parotid Gland Neoplasm, Maxillary Sinus Carcinoma, Nasal Cavity Carcinoma, Oral Cavity Carcinoma, Tongue Carcinoma, Tonsillar Carcinoma
Related terms Maxillary Sinus Neoplasms, Mouth Neoplasms, Parotid Neoplasms, Tongue Neoplasms, Tonsillar Neoplasms
Enrollment 88 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov