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Clinical Trials in Egypt / NCT06683560
Recruiting Not applicable

Printed Aligners for Nasoalveolar Molding Treatment

NCT06683560 · tracked via the Priya Life Science Egypt tracker
Sponsor
Ain Shams University
Phase
Not applicable
Started
2024-10-21
Last updated
2025-10-02

Condition(s) studied

Unilateral Complete Cleft Lip and Palate

Investigational drug(s) / intervention(s)

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

: 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

Study 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

Sex
ALL
Min age
—
Max age
45 Days
Healthy volunteers
No
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.

Primary outcome measure(s)

  • approximation of segments of maxillary arch — 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

Trial sites (2)

FacilityCityRegionStatus
Ain shams univerisity Cairo Abbasya Recruiting
Maha sabry Sayed Cairo Egypt Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06683560 on ClinicalTrials.gov ↗ ← All trials in Egypt