Fabrication of Naso-alveolar Molding (NAM) Appliance in Cleft Lip and Palate (CLP) From Digital Magnetic Resonance Imaging (MRI) Face Scan
Status
Terminated
Conditions
Cleft Lip and Palate
Treatments
Device: Traditional NAM
Device: 3D NAM
Details and patient eligibility
About
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.
Enrollment
1 patient
Sex
All
Ages
Under 1 year old
Volunteers
No 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.
Trial design
Primary purpose
Device Feasibility
Allocation
Non-Randomized
Interventional model
Single Group Assignment
Masking
None (Open label)
1 participants in 2 patient groups
3D NAM
Experimental group
Treatment:
Device: Traditional NAM
Device: 3D NAM
Traditional NAM
Active Comparator group
Treatment:
Device: Traditional NAM
Device: 3D NAM
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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