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Search / Trial NCT06683560

Printed Aligners for Nasoalveolar Molding Treatment

Launched by AIN SHAMS UNIVERSITY · Nov 8, 2024

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

3 Dimensional Aligner Nam Segmentation Approximation

ClinConnect Summary

This clinical trial is focused on a special treatment called nasoalveolar molding (NAM) for infants born with a condition known as unilateral complete cleft lip and palate. The study is testing a new type of printed aligner that makes it easier to provide this treatment. The goal is to help shape the baby's gums and palate to prepare them for future surgery. The unique design of this appliance, combined with advanced technology, aims to improve the care given to these infants.

To be eligible for this trial, infants must be up to 45 days old and have a specific type of cleft that is more than 5mm wide. Unfortunately, infants with other congenital issues or certain types of clefts will not qualify. Participants in the study can expect to visit the clinic every two weeks for ongoing care and adjustments. This trial is currently looking for participants, and it welcomes infants of all genders. If you are considering this treatment for your child, it could be a valuable opportunity to receive specialized care in a supportive environment.

Gender

ALL

Eligibility 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.

About Ain Shams University

Ain Shams University, established in Cairo, Egypt, is a prestigious higher education institution renowned for its commitment to academic excellence and research innovation. As a clinical trial sponsor, the university leverages its extensive resources and expertise in various medical and scientific disciplines to advance healthcare through rigorous research initiatives. With a focus on ethical practices and adherence to regulatory standards, Ain Shams University aims to contribute to the development of new therapies and improve patient outcomes, fostering collaboration among researchers, healthcare professionals, and industry partners in the pursuit of medical advancements.

Locations

Cairo, Abbasya, Egypt

Cairo, , Egypt

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported