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

Not Applicable

Terminated

• Conditions: Cleft Lip and Palate
• Interventions: Device: 3D NAM; Device: Traditional NAM

• Registration Number: NCT04369638
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-30
• Study Start: 2021-01-27
• Primary Completion: 2021-04-01
• Study Completion: 2021-04-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-31
• Last Update Posted: 2022-04-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3D NAM	Traditional NAM	-
Traditional NAM	3D NAM	-
3D NAM	3D NAM	-
Traditional NAM	Traditional NAM	-

Primary Outcome Measures

Name	Time	Method
Fit as measured by number of adjustments to the device	One month after MRI

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States