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 : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Kyle VanKoevering, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Prosthetic Treatment Craniofacial Abnormalities Maxillofacial Abnormalities Device: 3D digital scanning for maxillofacial prosthetics Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pilot Study on High Resolution 3D Digital Scanning for Maxillofacial Prosthetics for Feasibility and Efficacy
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 3D digital scanning for maxillofacial prosthetics 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.




Primary Outcome Measures :
  1. Number or weeks to create the final prosthesis [ Time Frame: up to 6 months ]
  2. Time the participants spend in the clinic [ Time Frame: up to 6 months ]
    This includes time spent with participant to design the prosthetic

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04035928


Contacts
Layout table for location contacts
Contact: Kyle Vankoevering, MD 734-232-9408 kylevk@umich.edu

Locations
Layout table for location information
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48170
Contact: Kyle Vankoevering, MD    734-232-9408    kylevk@umich.edu   
Sponsors and Collaborators
University of Michigan
Investigators
Layout table for investigator information
Principal Investigator: Kyle Vankoevering, MD University of Michigan

Layout table for additonal information
Responsible Party: Kyle VanKoevering, Assistant Professor of Otorhinolaryngology, University of Michigan
ClinicalTrials.gov Identifier: NCT04035928     History of Changes
Other Study ID Numbers: HUM00155762
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kyle VanKoevering, University of Michigan:
prosthetic treatment
rhinectomy
Additional relevant MeSH terms:
Layout table for MeSH terms
Craniofacial Abnormalities
Maxillofacial Abnormalities
Congenital Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Stomatognathic System Abnormalities
Stomatognathic Diseases