- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04369638
Fabrication of Naso-alveolar Molding (NAM) Appliance in Cleft Lip and Palate (CLP) From Digital Magnetic Resonance Imaging (MRI) Face Scan
March 31, 2022 updated by: Brett Thomas Chiquet, The University of Texas Health Science Center, Houston
Fabrication of NAM Appliance in CLP From Digital MRI Face Scan
The purpose of this study is to fabricate a nasoalveolar molding (NAM) appliance that is digitally fabricated and 3 dimensionally printed utilizing an MRI face scan and to assess the fit of the NAM in new borns with cleft lip and palate.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- The University of Texas Health Science Center at Houston
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second to 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- new born babies with cleft lip and/or palate
- will undergo treatment with UT Pediatric Dental Clinic with a NAM appliance
Exclusion Criteria:
- Patients without cleft lip and/or palate
- patients that cannot tolerate an intraoral appliance
- patients that are not able to be discharged from the hospital 2-3 days after birth.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 3D NAM
|
After consent and birth of the child, a face MRI will be taken of the newborn before discharge from the hospital utilizing the "feed and swaddle" technique.
The MRI will be sent to the dental team to convert into a format compatible with 3D software.
With the image, a NAM appliance will be digitally fabricated and 3D printed.
The 3D printed model will be tested for fit on stone model made from traditional impression.
Both traditional NAM and 3D printed NAM will be inserted at delivery appointment.
Fit will be assessed of both appliances by applying a try-in paste to the intaglio surface and counting the number of spots needing adjustment.
The patient will be seen for visit at the clinic for traditional intraoral impression and a dental stone model will be poured.
An acrylic NAM will be fabricated on the stone model.
The 3D printed model will be tested for fit on stone model made from traditional impression.
Both traditional NAM and 3D printed NAM will be inserted at delivery appointment.
Fit will be assessed of both appliances by applying a try-in paste to the intaglio surface and counting the number of spots needing adjustment.
|
Active Comparator: Traditional NAM
|
After consent and birth of the child, a face MRI will be taken of the newborn before discharge from the hospital utilizing the "feed and swaddle" technique.
The MRI will be sent to the dental team to convert into a format compatible with 3D software.
With the image, a NAM appliance will be digitally fabricated and 3D printed.
The 3D printed model will be tested for fit on stone model made from traditional impression.
Both traditional NAM and 3D printed NAM will be inserted at delivery appointment.
Fit will be assessed of both appliances by applying a try-in paste to the intaglio surface and counting the number of spots needing adjustment.
The patient will be seen for visit at the clinic for traditional intraoral impression and a dental stone model will be poured.
An acrylic NAM will be fabricated on the stone model.
The 3D printed model will be tested for fit on stone model made from traditional impression.
Both traditional NAM and 3D printed NAM will be inserted at delivery appointment.
Fit will be assessed of both appliances by applying a try-in paste to the intaglio surface and counting the number of spots needing adjustment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fit as measured by number of adjustments to the device
Time Frame: One month after MRI
|
One month after MRI
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Chelsea Wehr, DDS, The University of Texas Health Science Center, Houston
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 27, 2021
Primary Completion (Actual)
April 1, 2021
Study Completion (Actual)
April 1, 2021
Study Registration Dates
First Submitted
April 27, 2020
First Submitted That Met QC Criteria
April 27, 2020
First Posted (Actual)
April 30, 2020
Study Record Updates
Last Update Posted (Actual)
April 11, 2022
Last Update Submitted That Met QC Criteria
March 31, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-DB-20-0268
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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