Printed Aligners for Nasoalveolar Molding Treatment (NAM)

September 29, 2025 updated by: Maha Sabry Sayed, Ain Shams University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A sample of 10 infants born with unilateral cleft lip and palate (UCLP) ranging in age from seven to 45 days who meet the inclusion criteria will be recruited and subjected to the following study procedures: maxillary impression, extraoral scanning for nasolabial area and facial photos.

For digital workflow; the following steps will be done:

  1. Digital model preparation.
  2. Model segmentation and modification.
  3. Virtual treatment simulation.
  4. Virtual appliance construction.
  5. Three-dimensional aligner printing.

After aligners printing, each infant will be delivered his own set of aligners. The nasal stent will be fixed to the aligner then delivered with a meticulous demonstration for parents regarding adhesive placement, insertion, and removal. Parents will be instructed to remove the aligner once per day for proper cleaning.

Infants will be followed up every two weeks till maxillary arch segments approximation and improvement of nasolabial tissue morphology. Finally, post-treatment records will be taken.

• Study Setting: The study will be performed in the clinic of the Orthodontic Department, Faculty of Dentistry, Ain-Shams University.

• Study procedure: Infants who meet the inclusion criteria and approve participation in the study will be included. An informed consent will be signed by the infant's parents before their enrollment in the study in which the aim of the study, the methodology, and possible complications will be clearly described. This research will be reviewed by the Research Ethics Committee, Faculty of Dentistry, Ain Shams University.

IX. Statistical Analysis Methods of assessment

  1. Pre-operative T1 and postoperative T2 models will be digitally measured, assessed and compared.
  2. Pre-operative T1 and postoperative T2 soft tissue scans will be digitally measured, assessed and compared.
  3. Final virtual models and final infant models will be digitally compared.
  4. Total treatment duration will be calculated. Finally, data will be tabulated and statistically analyzed

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: infants born with complete unilateral cleft lip and palate
photopolymer resin material "graphy" Tera Harz 85 will be used to print 3D printed aligners for nasoalveolar molding treatment
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
Other Names:
  • NAM device
  • NAM aligner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
approximation of segments of maxillary arch
Time Frame: 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
almost 1.5 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

November 7, 2024

First Submitted That Met QC Criteria

November 8, 2024

First Posted (Actual)

November 12, 2024

Study Record Updates

Last Update Posted (Estimated)

October 2, 2025

Last Update Submitted That Met QC Criteria

September 29, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nasoalveolar molding

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

patients age, severity of malocclusion, photos

IPD Sharing Time Frame

11/2024 12/2025

IPD Sharing Access Criteria

Noha Ibrahim google drive 11/2024

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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