Back to resultsFabrication of Naso-alveolar Molding (NAM) Appliance in Cleft Lip and Palate (CLP) From Digital Magnetic Resonance Imaging (MRI) Face Scan
Primary Purpose
Cleft Lip and Palate
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3D NAM
Traditional NAM
Sponsored by
About this trial
This is an interventional device feasibility trial for Cleft Lip and Palate focused on measuring nasoalveloar molding, 3D printing, MRI
Eligibility Criteria
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.
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
3D NAM
Traditional NAM
Arm Description
Outcomes
Primary Outcome Measures
Fit as measured by number of adjustments to the device
Secondary Outcome Measures
Full Information
NCT ID
NCT04369638
First Posted
April 27, 2020
Last Updated
March 31, 2022
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT04369638
Brief Title
Fabrication of Naso-alveolar Molding (NAM) Appliance in Cleft Lip and Palate (CLP) From Digital Magnetic Resonance Imaging (MRI) Face Scan
Official Title
Fabrication of NAM Appliance in CLP From Digital MRI Face Scan
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
PI left institution
Study Start Date
January 27, 2021 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
April 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Lip and Palate
Keywords
nasoalveloar molding, 3D printing, MRI
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3D NAM
Arm Type
Experimental
Arm Title
Traditional NAM
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
3D NAM
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Traditional NAM
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fit as measured by number of adjustments to the device
Time Frame
One month after MRI
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chelsea Wehr, DDS
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Fabrication of Naso-alveolar Molding (NAM) Appliance in Cleft Lip and Palate (CLP) From Digital Magnetic Resonance Imaging (MRI) Face Scan
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