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

NCT04369638 | Terminated FDA Device

• 1 other identifier: HSC-DB-20-0268
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Cleft Lip and Palate

Keywords

nasoalveloar molding; 3D printing; MRI

Outcome Measures

Primary Outcomes (1)

• Fit as measured by number of adjustments to the device

  One month after MRI

Study Arms (2)

3D NAM

EXPERIMENTAL

Device: 3D NAM; Device: Traditional NAM

Traditional NAM

ACTIVE COMPARATOR

Device: 3D NAM; Device: Traditional NAM

Interventions

3D NAM DEVICE

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.

3D NAM; Traditional NAM

Traditional NAM DEVICE

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.

3D NAM; Traditional NAM

Eligibility Criteria

• Age: 0 Days - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• new born babies with cleft lip and/or palate
• will undergo treatment with UT Pediatric Dental Clinic with a NAM appliance

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Cleft Lip

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Chelsea Wehr, DDS

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 30, 2020
• Study Start: January 27, 2021
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: April 11, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)