Evaluation of 3D Printed Aligners for Nasoalveolar Molding in Infants Born With Unilateral Complete Cleft Lip and Palate
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Ain Shams University
- Enrollment
- 20
- Locations
- 4
- Primary Endpoint
- approximation of segments of maxillary arch
Study Overview
Brief Summary
study will provide nasoalveolar molding (NAM) treatment, special care for infants born with cleft lip and palate. This novel appliance will help to provide the care in accurate and easy form by help of both digital work flow and new material which provide a unique properties.
Detailed Description
A sample of 10 infants born with unilateral cleft lip and palate (UCLP) ranging in age from seven to 45 days who meet the inclusion criteria will be recruited and subjected to the following study procedures: maxillary impression, extraoral scanning for nasolabial area and facial photos.
For digital workflow; the following steps will be done:
- Digital model preparation.
- Model segmentation and modification.
- Virtual treatment simulation.
- Virtual appliance construction.
- Three-dimensional aligner printing.
After aligners printing, each infant will be delivered his own set of aligners. The nasal stent will be fixed to the aligner then delivered with a meticulous demonstration for parents regarding adhesive placement, insertion, and removal. Parents will be instructed to remove the aligner once per day for proper cleaning.
Infants will be followed up every two weeks till maxillary arch segments approximation and improvement of nasolabial tissue morphology. Finally, post-treatment records will be taken.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- — to 45 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Non-syndromic complete unilateral cleft lip, alveolus, and palate.
- •Age is up to 45 days.
- •Cleft size more than 5mm between anterior margins of cleft segments.
Exclusion Criteria
- •Infants are diagnosed with other congenital malformations.
- •Parents refusing NAM treatment.
- •Parents are unable to attend the clinic every 2 weeks.
- •Infants are born with another form of clefts like facial and median clefts.
Arms & Interventions
infants born with complete unilateral cleft lip and palate
photopolymer resin material "graphy" Tera Harz 85 will be used to print 3D printed aligners for nasoalveolar molding treatment
Intervention: : photopolymer resin material "graphy" Tera Harz 85 will be used to print 3D printed aligners for NAM treatment (Device)
Outcomes
Primary Outcomes
approximation of segments of maxillary arch
Time Frame: almost 1.5 month
measuring the alveolar cleft size before and after the treatment to assess the amount of cleft reduction on the scanned models in millimeter
Secondary Outcomes
No secondary outcomes reported
Investigators
Maha Sabry Sayed
assistant lecturer
Ain Shams University