Printed Aligners for Nasoalveolar Molding Treatment
NAM
Evaluation of 3D Printed Aligners for Nasoalveolar Molding in Infants Born With Unilateral Complete Cleft Lip and Palate
1 other identifier
interventional
20
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2024
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 21, 2024
CompletedFirst Submitted
Initial submission to the registry
November 7, 2024
CompletedFirst Posted
Study publicly available on registry
November 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
October 2, 2025
September 1, 2025
1.7 years
November 7, 2024
September 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
approximation of segments of maxillary arch
measuring the alveolar cleft size before and after the treatment to assess the amount of cleft reduction on the scanned models in millimeter
almost 1.5 month
Study Arms (1)
infants born with complete unilateral cleft lip and palate
EXPERIMENTALphotopolymer resin material "graphy" Tera Harz 85 will be used to print 3D printed aligners for nasoalveolar molding treatment
Interventions
3d printed NAM aligner is made from novel photopolymer resin as a novel device
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Ain shams univerisity
Cairo, Abbasya, 11658, Egypt
Maha sabry Sayed
Cairo, 11658, Egypt
Related Publications (1)
Batra P, Raghavan S, Gribel BF. Nasoalveolar molding appliances. Am J Orthod Dentofacial Orthop. 2021 Feb;159(2):e85. doi: 10.1016/j.ajodo.2020.11.017. No abstract available.
PMID: 33546838BACKGROUND
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant lecturer
Study Record Dates
First Submitted
November 7, 2024
First Posted
November 12, 2024
Study Start
October 21, 2024
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
October 2, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 11/2024 12/2025
- Access Criteria
- Noha Ibrahim google drive 11/2024
patients age, severity of malocclusion, photos