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NCT04369638 Clinical Trial

Fabrication of Naso-alveolar Molding (NAM) Appliance in Cleft Lip and Palate (CLP) From Digital Magnetic Resonance Imaging (MRI) Face Scan

Cleft Lip and Palate Clinical Trial

Official title:
Fabrication of NAM Appliance in CLP From Digital MRI Face Scan

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04369638
Other study ID # HSC-DB-20-0268
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date January 27, 2021
Est. completion date April 1, 2021

Study information
Verified date March 2022
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 1
Est. completion date April 1, 2021
Est. primary completion date April 1, 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 1 Year
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• 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.
• Traditional NAM
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.

Locations
Country Name City State
United States The University of Texas Health Science Center at Houston Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fit as measured by number of adjustments to the device One month after MRI
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