Evidence map›Paper›PMID 32298994›Full record

ArticleOral oncology2020

A prospective parallel design study testing non-inferiority of customized oral stents made using 3D printing or manually fabricated methods.

Mohamed Zaid, Eugene J Koay, Nimit Bajaj, Ryan Mathew, Lianchun Xiao, Anshuman Agrawal, Pearl Fernandes, Hannah Burrows, Millicent A Roach, Christopher T Wilke and 11 more

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Oral oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.8field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 14 citations in OpenAlex.

  1. Observational
  2. Review
  3. ACR-ARS Practice Parameter for the Performance of Proton Beam Therapy.International journal of particle therapy · 2024
    Article
  4. Article
  5. Protective and positioning devices in maxillofacial prosthodontics and radiotherapy: Overview.Technical innovations & patient support in radiation oncology · 2022
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors at 2 institutions in 1 country.

Mohamed ZaidDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, United States.
Eugene J KoayDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, United States. Electronic address: EKoay@mdanderson.org.
Nimit BajajDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, United States.
Ryan MathewDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, United States.
Lianchun XiaoDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, United States.
Anshuman AgrawalDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, United States.
Pearl FernandesDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, United States.
Hannah BurrowsDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, United States.
Millicent A RoachDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, United States.
Christopher T WilkeDepartment of Radiation Oncology, University of Minnesota Medical School, 516 Delaware St SE, Minneapolis, MN 55455, United States.
Caroline ChungDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, United States.
Clifton D FullerDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, United States.
Jack PhanDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, United States.
G Brandon GunnDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, United States.
William H MorrisonDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, United States.
Adam S GardenDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, United States.
Steven J FrankDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, United States.
David I RosenthalDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, United States.
Michael AndersenDepartment of Head and Neck Surgery, Division of Surgery, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, United States.
Adegbenga OtunDepartment of Head and Neck Surgery, Division of Surgery, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, United States.
Mark S ChambersDepartment of Head and Neck Surgery, Division of Surgery, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, United States.
The University of Texas MD Anderson Cancer Center · USUniversity of Minnesota Medical Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
Targeting the p53 pathway for reversal of oral premalignancyP50CA097007 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI MILLS, GORDON B. · 2002 to 2012
$26.1M
TRANS-NETWORK PROJECTSU54CA143837 · NCI · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI CRISTINI, VITTORIO · 2009 to 2014
$10.8M
Transport Oncophysics CoreU54CA210181 · NCI · METHODIST HOSPITAL RESEARCH INSTITUTE · PI CHANG, JENNY C-N, SHEN, HAIFA · 2016 to 2020
$9.3M
Imaging and Molecular Correlates of Progression in Cystic Neoplasms of the PancreasU01CA196403 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI MAITRA, ANIRBAN · 2015 to 2020
$5.8M
Using Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) to Establish Objective Clinical Outcome Measures for Mandibular OsteoradionecrosisR01DE025248 · NIDCR · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI LAI, STEPHEN Y · 2016 to 2020
$2.9M
SMART-ACT: Spatial Methodologic Approaches for Risk Assessment and Therapeutic Adaptation in Cancer TreatmentR01CA214825 · NCI · UNIVERSITY OF ILLINOIS AT CHICAGO · PI CANAHUATE, GUADALUPE, FULLER, CLIFTON DAVID · 2017 to 2019
$1.1M
imaging Radiation-Associated Dysphagia (iRAD)R01CA218148 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI FULLER, CLIFTON DAVID, HUTCHESON, KATHERINE ARNOLD · 2017 to 2019
$810k
Using Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) to Establish Objective Clinical Outcome Measures for Mandibular OsteoradionecrosisR56DE025248 · NIDCR · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI LAI, STEPHEN Y · 2015 to 2015
$470k
NCI NIH HHS P30 CA016672NCI NIH HHS P50 CA097007NCI NIH HHS R01 CA214825NCI NIH HHS R01 CA218148NCI NIH HHS U01 CA196403NCI NIH HHS U54 CA143837NCI NIH HHS U54 CA210181NIDCR NIH HHS R01 DE025248NIDCR NIH HHS R56 DE025248
6 · The paper itself

Abstract

background and purposeCustomized mouth-opening-tongue-depressing-stents (MOTDs) may reduce toxicity in patients with head and neck cancers (HNC) receiving radiotherapy (RT). However, making MOTDs requires substantial resources, which limits their utilization. Previously, we described a workflow for fabricating customized 3D-printed MOTDs. This study reports the results of a prospective trial testing the non-inferiority of 3D-printed to standard and commercially-available (TruGuard) MOTDs as measured by patient reported outcomes (PROs). MATERIALS AND

methodsPROs were collected at 3 time points: (t1) simulation, (t2) prior to RT, (t3) between fractions 15-25 of RT. Study participants received a 3D-printed MOTDs (t1, t2, t3), a wax-pattern (t1), an acrylic-MOTDs (t2, t3) and an optional TruGuard (t1, t2, t3). Patients inserted the stents for 5-10 min and completed a PRO-questionnaire covering ease-of-insertion and removal, gagging, jaw-pain, roughness and stability. Inter-incisal opening and tongue-displacement were recorded. With 39 patients, we estimated 90% power to detect a non-inferiority margin of 2 at a significance level of 0.025. Matched pairs and t-test were used for statistics.

results41 patients were evaluable. The 3D-printed MOTDs achieved a significantly better overall PRO score compared to the wax-stent (p = 0.0007) and standard-stent (p = 0.0002), but was not significantly different from the TruGuard (p = 0.41). There was no difference between 3D-printed and standard MOTDs in terms of inter-incisal opening (p = 0.4) and position reproducibility (p = 0.98). The average 3D-printed MOTDs turn-around time was 8 vs 48 h for the standard-stent.

conclusions3D-printed stents demonstrated non-inferior PROs compared to TruGuard and standard-stents. Our 3D-printing process may expand utilization of MOTDs.

Indexed as

AdultAgedFemaleHead and Neck NeoplasmsHumansMaleMiddle AgedPrinting, Three-DimensionalProspective StudiesStents3D printingHead and neck cancerOral stentRadiation therapy

Identifiers

PMID32298994
PMCPMC7350149
OpenAlexW3016523608

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.