Trials / Terminated
TerminatedNCT04369638
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- The University of Texas Health Science Center, Houston · Academic / Other
- Sex
- All
- Age
- 0 Days – 1 Year
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-01-27
- Primary completion
- 2021-04-01
- Completion
- 2021-04-01
- First posted
- 2020-04-30
- Last updated
- 2022-04-11
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04369638. Inclusion in this directory is not an endorsement.