Unilateral Complete Cleft Lip and PalateNAMNCT06683560
Printed Aligners for Nasoalveolar Molding Treatment
A study testing : photopolymer resin material "graphy" Tera Harz 85 will be used to print 3D printed aligners for NAM treatment in people with Unilateral Complete Cleft Lip and Palate, run by Ain Shams University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 45 days
- Conditions the study is for
- Unilateral Complete Cleft Lip and Palate
- What is being tested?
- : photopolymer resin material "graphy" Tera Harz 85 will be used to print 3D printed aligners for NAM treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Dec 2024to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 45 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Ain shams univerisity
Cairo, Abbasya, 11658
Maha sabry Sayed
Cairo, 11658
About this study
Official title: 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.
Read the 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:
- Digital model preparation.
- Model segmentation and modification.
- Virtual treatment simulation.
- Virtual appliance construction.
- 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
- Pre-operative T1 and postoperative T2 models will be digitally measured, assessed and compared.
- Pre-operative T1 and postoperative T2 soft tissue scans will be digitally measured, assessed and compared.
- Final virtual models and final infant models will be digitally compared.
- Total treatment duration will be calculated. Finally, data will be tabulated and statistically analyzed
- Conditions
- Unilateral Complete Cleft Lip and Palate
- Being tested
- : photopolymer resin material "graphy" Tera Harz 85 will be used to print 3D printed aligners for NAM treatment
- Keywords
- 3-dimensional, aligner, NAM, segmentation, Approximation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
: photopolymer resin material "graphy" Tera Harz 85 will be used to print 3D printed aligners for NAM treatmentDevice
Also called NAM device, NAM aligner
3d printed NAM aligner is made from novel photopolymer resin as a novel device
| Study group | Role | What they receive |
|---|---|---|
| infants born with complete unilateral cleft lip and palate | Experimental | photopolymer resin material "graphy" Tera Harz 85 will be used to print 3D printed aligners for nasoalveolar molding treatment Receives: Device: : photopolymer resin material "graphy" Tera Harz 85 will be used to print 3D printed aligners for NAM treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: almost 1.5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Dec 2024
- Primary completion5 Mar 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unilateral Complete Cleft Lip and PalateStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Sabry Sayed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683560
- Sponsor's protocol ID
- Nasoalveolar molding
- Acronym
- NAM
- Status last verified
- Sep 2024
- First submitted
- 7 Nov 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: patients age, severity of malocclusion, photos
Publications
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.
PubMed 33546838
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 3D Printed Aligners for Nasoalveolar Molding in Infants Born With Unilateral Complete Cleft Lip and Palate
- ClinicalTrials.gov ID
- NCT06683560
- Acronym / sponsor ID
- NAM / Nasoalveolar molding
- Conditions
- Unilateral Complete Cleft Lip and Palate
- Keywords
- 3-dimensional, aligner, NAM, segmentation, Approximation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 5 Mar 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Digital model preparation.
- Model segmentation and modification.
- Virtual treatment simulation.
- Virtual appliance construction.
- 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
- Pre-operative T1 and postoperative T2 models will be digitally measured, assessed and compared.
- Pre-operative T1 and postoperative T2 soft tissue scans will be digitally measured, assessed and compared.
- Final virtual models and final infant models will be digitally compared.
- Total treatment duration will be calculated. Finally, data will be tabulated and statistically analyzed
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| infants born with complete unilateral cleft lip and palate | Experimental | Device: : photopolymer resin material "graphy" Tera Harz 85 will be used to print 3D printed aligners for NAM treatmentphotopolymer resin material "graphy" Tera Harz 85 will be used to print 3D printed aligners for nasoalveolar molding treatment |
Who may qualify
- Ages
- Up to 45 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| : photopolymer resin material "graphy" Tera Harz 85 will be used to print 3D printed aligners for NAM treatmentAlso: NAM device, NAM aligner3d printed NAM aligner is made from novel photopolymer resin as a novel device | Device | infants born with complete unilateral cleft lip and palate |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Results publication: PubMed 33546838Batra 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.
- Individual participant dataSharing planned: Yes. patients age, severity of malocclusion, photos
Related trials for Unilateral Complete Cleft Lip and Palate
Not yet recruiting
MRI Assessment of Velopharyngeal Anatomy After Modified Furlow-Buccinator Flap in Late Primary Palate Repair
Cleft Palate, Cleft Palate, Unilateral, Complete
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing : photopolymer resin material "graphy" Tera Harz 85 will be used to print 3D printed aligners for NAM treatment in people with Unilateral Complete Cleft Lip and Palate, run by Ain Shams University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
approximation of segments of maxillary arch (time frame: almost 1.5 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06683560, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.