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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cleft Lip and Palate

Intervention / Treatment
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* Device: 3D NAM
* Device: Traditional NAM


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D NAM<br> | Device: 3D NAM<br>* 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.<br>Device: Traditional NAM<br>* 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.<br>|
| Active Comparator: Traditional NAM<br> | Device: 3D NAM<br>* 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.<br>Device: Traditional NAM<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fit as measured by number of adjustments to the device |  | One month after MRI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, nasoalveloar molding, 3D printing