Prosthetic TreatmentNCT04035928
Digital Design for Maxillofacial Prosthetics
A study testing 3D digital scanning for maxillofacial prosthetics in people with Prosthetic Treatment and Craniofacial Abnormalities, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Prosthetic Treatment, Craniofacial Abnormalities, Maxillofacial Abnormalities
- What is being tested?
- 3D digital scanning for maxillofacial prosthetics
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2019to Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Known allergy to silicone
- Poor candidate for prosthetic reconstruction
- Developmental concerns regarding aspiration risk
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study on High Resolution 3D Digital Scanning for Maxillofacial Prosthetics for Feasibility and Efficacy
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.
- Being tested
- 3D digital scanning for maxillofacial prosthetics
- Keywords
- prosthetic treatment, rhinectomy
- Medical subject headings
- Craniofacial Abnormalities, Maxillofacial Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D digital scanning for maxillofacial prostheticsDevice
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 group | Role | What they receive |
|---|---|---|
| 3D digital scanning for maxillofacial prosthetics | Experimental | Not described Receives: Device: 3D digital scanning for maxillofacial prosthetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number or weeks to create the final prosthesis
Measured: up to 6 months
Time the participants spend in the clinic
This includes time spent with participant to design the prosthetic
Measured: up to 6 months
Number of hours spent to create the prosthetic
The number of hours will be calculated by using the design software, scanners, printing, and modifying the mold and prosthesis.
Measured: up to 6 months
Secondary outcomes (5)
Satisfaction measured by modified Toronto Outcome Measure of Craniofacial Prosthetics (TOMCP) for intraoral prosthesis.
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.
Measured: up to 6 months after the prosthetic is completed and being used
Satisfaction measured by modified Toronto Outcome Measure of Craniofacial Prosthetics (TOMCP) for extraoral prosthesis.
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.
Measured: up to 6 months after the prosthetic is completed and being used
Quality of life measures by modified Toronto Outcome Measure of Craniofacial Prosthetics (TOMCP) for intraoral prosthesis.
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.
Measured: up to 6 months after the prosthetic is completed and being used
Quality of life measures by modified Toronto Outcome Measure of Craniofacial Prosthetics (TOMCP) for extraoral prosthesis.
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.
Measured: up to 6 months after the prosthetic is completed and being used
Number of adverse events related to the prosthetic
This study will collect and report adverse events (serious and non-serious) at least possibly related to the prosthetic.
Measured: up to 6 months after the prosthetic is completed and being used
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start14 Oct 2019
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Why it stopped: Recruitment never initiated, change of staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic TreatmentStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Zopf, University of Michigan
- Investigators
- David Zopf, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035928
- Sponsor's protocol ID
- HUM00155762
- Status last verified
- Jun 2024
- First submitted
- 10 Jul 2019
- Last updated
- 24 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on High Resolution 3D Digital Scanning for Maxillofacial Prosthetics for Feasibility and Efficacy
- ClinicalTrials.gov ID
- NCT04035928
- Acronym / sponsor ID
- HUM00155762
- Keywords
- prosthetic treatment, rhinectomy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment never initiated, change of staff
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 29 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D digital scanning for maxillofacial prosthetics | Experimental | Device: 3D digital scanning for maxillofacial prosthetics |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Known allergy to silicone
- Poor candidate for prosthetic reconstruction
- Developmental concerns regarding aspiration risk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D digital scanning for maxillofacial prostheticsThe 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. | Device | 3D digital scanning for maxillofacial prosthetics |
Primary outcome
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.
5 secondary outcomes
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
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
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
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
Number of adverse events related to the prosthetic
Time frame: up to 6 months after the prosthetic is completed and being used
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Zopf, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D digital scanning for maxillofacial prosthetics in people with Prosthetic Treatment and Craniofacial Abnormalities, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number or weeks to create the final prosthesis (time frame: up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.