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Device

3D digital scanning for maxillofacial prosthetics for Maxillofacial Abnormalities

N/A

Recruiting

Led By Kyle Vankoevering, MD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

Study Summary

This trial will use a 3D scanner to print a model of a prosthesis for each patient. The goal is to provide a new, faster method that preserves quality while reducing time for patients and providers.

Eligible Conditions

Maxillofacial Abnormalities
Craniofacial Dysmorphism
Prosthetic Treatment

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of hours spent to create the prosthetic

Number or weeks to create the final prosthesis

Time the participants spend in the clinic

Secondary outcome measures

Number of adverse events related to the prosthetic

Quality of life measures by modified Toronto Outcome Measure of Craniofacial Prosthetics (TOMCP) for extraoral prosthesis.

Prosthesis

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: 3D digital scanning for maxillofacial prostheticsExperimental Treatment1 Intervention

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Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,794 Previous Clinical Trials

6,373,886 Total Patients Enrolled

Kyle Vankoevering, MDPrincipal InvestigatorUniversity of Michigan

David Zopf, MDPrincipal Investigator - University of Michigan

University of Michigan Hospital, Von Voigtlander Women's Hospital

1 Previous Clinical Trials

40 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the breadth of participation for this clinical trial?

"Verified, according to clinicaltrials.gov this medical study is presently recruiting. It was initially posted on October 14th 2019 and the last update took place on May 31st 2022. 30 patients are required from a single centre for participation in the trial."

Answered by AI

Are there opportunities for enrolment in this clinical trial at present?

"According to the official clinicaltrials.gov page, recruitment for this research trial is ongoing. This project was initially publicised on October 14th 2019 and last edited on May 31st 2022."

Answered by AI

What objectives is this experiment aiming to accomplish?

"This trial's primary objective, to be measured over a six month period, is the amount of time it takes for the prosthesis to be created. Secondary outcomes include Quality of Life measurements through modified Toronto Outcome Measure of Craniofacial Prosthetics (TOMCP) surveys - with an intra-oral and extra-oral iteration respectively – which are rated on a 7 point Likert scale. Additionally, any adverse events related to the prosthetic will also be collected and reported."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Digital Design for Maxillofacial Prosthetics

David Zopf 2019. "Digital Design for Maxillofacial Prosthetics". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04035928.