Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-10-21
2026-08-01
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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
: 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
Interventions
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: 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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age is up to 45 days.
3. Cleft size more than 5mm between anterior margins of cleft segments.
Exclusion Criteria
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.
45 Days
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Maha Sabry Sayed
assistant lecturer
Locations
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Ain shams univerisity
Cairo, Abbasya, Egypt
Maha sabry Sayed
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Role: backup
References
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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.
Other Identifiers
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Nasoalveolar molding
Identifier Type: -
Identifier Source: org_study_id
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