3D Printed Aligners for Treating Cleft Lip and Palate in Infants
Evaluation of 3D Printed Aligners for Nasoalveolar Molding in Infants Born With Unilateral Complete Cleft Lip and Palate
NA · Ain Shams University · NCT06683560
This study is testing a new 3D printed aligner to see if it can help infants with cleft lip and palate get better treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | N/A to 45 Days |
| Sex | All |
| Sponsor | Ain Shams University (other) |
| Locations | 2 sites (Cairo, Abbasya and 1 other locations) |
| Trial ID | NCT06683560 on ClinicalTrials.gov |
What this trial studies
This study aims to provide nasoalveolar molding (NAM) treatment for infants with unilateral cleft lip and palate using a novel 3D printed aligner. A sample of 10 infants aged 7 to 45 days will undergo a series of procedures including maxillary impression and extraoral scanning. The digital workflow involves creating a digital model, simulating treatment, and constructing a customized aligner. Parents will be instructed on the use and maintenance of the aligners, with follow-up visits every two weeks to monitor progress.
Who should consider this trial
Good fit: Ideal candidates are infants up to 45 days old with non-syndromic complete unilateral cleft lip and palate.
Not a fit: Patients with other congenital malformations or different types of clefts may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this approach could enhance the effectiveness and ease of NAM treatment for infants with cleft lip and palate.
How similar studies have performed: While this approach is innovative, similar studies using digital workflows and 3D printing in orthodontics have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 1. Non-syndromic complete unilateral cleft lip, alveolus, and palate. 2. Age is up to 45 days. 3. Cleft size more than 5mm between anterior margins of cleft segments. Exclusion Criteria 1. Infants are diagnosed with other congenital malformations. 2. Parents refusing NAM treatment. 3. Parents are unable to attend the clinic every 2 weeks. 4. Infants are born with another form of clefts like facial and median clefts.
Where this trial is running
Cairo, Abbasya and 1 other locations
- Ain shams univerisity — Cairo, Abbasya, Egypt (RECRUITING)
- Maha sabry Sayed — Cairo, Egypt (RECRUITING)
Study contacts
- Study coordinator: Maha S Sayed, as. lecturer
- Email: mahasabry@asfd.asu.edu.eg
- Phone: 01021231617
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Unilateral Complete Cleft Lip and Palate, 3-dimensional, aligner, NAM, segmentation, Approximation