RecruitingNot ApplicableNCT06683560

Printed Aligners for Nasoalveolar Molding Treatment

Evaluation of 3D Printed Aligners for Nasoalveolar Molding in Infants Born With Unilateral Complete Cleft Lip and Palate


Sponsor

Ain Shams University

Enrollment

20 participants

Start Date

Oct 21, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Max Age: 45 Days

Plain Language Summary

Simplified for easier understanding

This study tests whether 3D-printed dental aligners can be used to reshape the nose and gums in newborns born with a cleft lip and palate, as an alternative to traditional hand-made devices. **You may be eligible if...** - Your baby has a complete cleft lip, gum, and palate on one side only (unilateral, non-syndromic) - Your baby is 45 days old or younger - The gap in the cleft is more than 5 mm wide **You may NOT be eligible if...** - Your baby has other birth defects or conditions - You are not willing to use the dental molding (NAM) treatment - You cannot attend clinic visits every 2 weeks - Your baby has a different type of cleft (such as a facial or midline cleft) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICE: photopolymer resin material "graphy" Tera Harz 85 will be used to print 3D printed aligners for NAM treatment

3d printed NAM aligner is made from novel photopolymer resin as a novel device


Locations(2)

Ain shams univerisity

Cairo, Abbasya, Egypt

Maha sabry Sayed

Cairo, Egypt

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NCT06683560