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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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ClinicalTrials.gov Identifier: NCT04369638
Recruitment Status : Not yet recruiting
First Posted : April 30, 2020
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Chelsea Wehr, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Cleft Lip and Palate Device: 3D NAM Device: Traditional NAM Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Fabrication of NAM Appliance in CLP From Digital MRI Face Scan
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 3D NAM 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.

Device: 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.

Active Comparator: Traditional NAM 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.

Device: 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.




Primary Outcome Measures :
  1. Fit as measured by number of adjustments to the device [ Time Frame: One month after MRI ]


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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369638


Contacts
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Contact: Chelsea Wehr, DDS (713) 500-8220 Chelsea.L.Hermes@uth.tmc.edu
Contact: Audrena Hankins (713) 486-2576 Audrena.Hankins@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Contact: Chelsea Wehr, DDS    713-500-8220    Chelsea.L.Hermes@uth.tmc.edu   
Contact: Audrena Hankins    (713) 486-2576    Audrena.Hankins@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Chelsea Wehr, DDS The University of Texas Health Science Center, Houston
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Responsible Party: Chelsea Wehr, Resident, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT04369638    
Other Study ID Numbers: HSC-DB-20-0268
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Chelsea Wehr, The University of Texas Health Science Center, Houston:
nasoalveloar molding
3D printing
MRI
Additional relevant MeSH terms:
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Cleft Lip
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities