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

Fabrication of NAM Appliance in CLP From Digital MRI Face Scan

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04369638

Enrollment

Registered

2020-04-30

Start date

2021-01-27

Completion date

2021-04-01

Last updated

2022-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Lip and Palate

Keywords

nasoalveloar molding, 3D printing, MRI

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.

Interventions

DEVICE3D 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.

DEVICETraditional 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

0 Days to 1 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Fit as measured by number of adjustments to the device	One month after MRI

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026