Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Digital Design for Maxillofacial Prosthetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04035928
Recruitment Status : Recruiting
First Posted : July 29, 2019
Last Update Posted : June 4, 2021
Sponsor:
Information provided by (Responsible Party):
David Zopf, University of Michigan

Tracking Information
First Submitted Date  ICMJE July 10, 2019
First Posted Date  ICMJE July 29, 2019
Last Update Posted Date June 4, 2021
Actual Study Start Date  ICMJE October 14, 2019
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2019)
  • Number or weeks to create the final prosthesis [ Time Frame: up to 6 months ]
  • Time the participants spend in the clinic [ Time Frame: up to 6 months ]
    This includes time spent with participant to design the prosthetic
  • Number of hours spent to create the prosthetic [ Time Frame: up to 6 months ]
    The number of hours will be calculated by using the design software, scanners, printing, and modifying the mold and prosthesis.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2019)
  • Satisfaction measured by modified Toronto Outcome Measure of Craniofacial Prosthetics (TOMCP) for intraoral prosthesis. [ Time Frame: up to 6 months after the prosthetic is completed and being used ]
    Survey questions are all created using a 7-point Likert scale for assessment. Questions 10-17 from the survey will be used to measure the patients prosthesis level of satisfaction (the higher the score the more satisfied). These will be completed pre-prosthesis and at 1 month and 6 months post prosthesis for patients with intraoral prosthesis.
  • Satisfaction measured by modified Toronto Outcome Measure of Craniofacial Prosthetics (TOMCP) for extraoral prosthesis. [ Time Frame: up to 6 months after the prosthetic is completed and being used ]
    Survey questions are all created using a 7-point Likert scale for assessment. Questions 8-19 from the survey will be used to measure the patients level of satisfaction (the higher the score the more satisfied). These will be completed pre-prosthesis and at 1 month and 6 months post prosthesis for patients with extraoral prosthesis.
  • Quality of life measures by modified Toronto Outcome Measure of Craniofacial Prosthetics (TOMCP) for intraoral prosthesis. [ Time Frame: up to 6 months after the prosthetic is completed and being used ]
    Survey questions are all created using a 7-point Likert scale for assessment. Questions 1-9 from the survey will be used to measure the patients level of quality of life (the higher score indicates better quality). These will be completed pre-prosthesis and at 1 month and 6 months post prosthesis for patients with intraoral prosthesis.
  • Quality of life measures by modified Toronto Outcome Measure of Craniofacial Prosthetics (TOMCP) for extraoral prosthesis. [ Time Frame: up to 6 months after the prosthetic is completed and being used ]
    Survey questions are all created using a 7-point Likert scale for assessment. Questions 1-7 from the survey will be used to measure the patients quality of life (the higher score indicates be better quality). These will be completed pre-prosthesis and at 1 month and 6 months post prosthesis for patients with extraoral prosthesis.
  • Number of adverse events related to the prosthetic [ Time Frame: up to 6 months after the prosthetic is completed and being used ]
    This study will collect and report adverse events (serious and non-serious) at least possibly related to the prosthetic.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Digital Design for Maxillofacial Prosthetics
Official Title  ICMJE Pilot Study on High Resolution 3D Digital Scanning for Maxillofacial Prosthetics for Feasibility and Efficacy
Brief Summary This study will use a 3D scanner to print a 3D model or mold for each patient's prosthesis. The goal of this study to provide patients with a new, faster method of imaging and creating prostheses that preserves the quality of the current method while reducing time spent by both the patient and providers. Patients that are eligible will have a non-invasive 3D scanner (Artec Space Spider) to image the indicated areas of their head and face to help create their new prosthesis. Patients will come in for visits as needed to fit and adjust their prosthetic. Additionally, patients will be asked to complete questionnaires and have follow-up visits at certain time -points pre and post prosthetic completion.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Prosthetic Treatment
  • Craniofacial Abnormalities
  • Maxillofacial Abnormalities
Intervention  ICMJE Device: 3D digital scanning for maxillofacial prosthetics
The non-invasive Artec Space Spider 3D scanner will be used to image the indicated areas of the patients head and face. In the case of an intraoral defect, the noninvasive TRIOS intraoral 3D scanner will be used. The study may also use nasometry or nasal endoscopy to measure the amount of airflow through the patient's fistula to help guide the design. The software that will be used will create a 3D image of the prosthesis during the patient's clinic appointment. Once a model of the prosthesis is fully designed and manufactured, the patient will return to clinic for a second appointment which may involve fitting and coloring. A subsequent appointment will involve delivery of a successfully fitted and colored prosthesis that the patient will take home.
Study Arms  ICMJE Experimental: 3D digital scanning for maxillofacial prosthetics
Intervention: Device: 3D digital scanning for maxillofacial prosthetics
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 24, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2023
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Maxillofacial anatomic defect or anomaly that limits function or cosmesis (including facial and/or intraoral)
  • Stable defect (no clinically active tumor or plans for major reconstructive surgery)
  • The patient (or family) have elected to pursue a prosthetic reconstruction of a craniofacial anomaly
  • The patient is amenable to 3D surface scanning rather than facial molding

Exclusion Criteria:

  • Known allergy to silicone
  • Poor candidate for prosthetic reconstruction
  • Developmental concerns regarding aspiration risk
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kyle Vankoevering, MD 734-232-9408 kylevk@umich.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04035928
Other Study ID Numbers  ICMJE HUM00155762
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Zopf, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kyle Vankoevering, MD University of Michigan
PRS Account University of Michigan
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP