Crown Movement in Cases Treated With Direct Printed Aligners
NCT ID: NCT07273435
Last Updated: 2025-12-09
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
23 participants
INTERVENTIONAL
2025-06-01
2026-07-01
Brief Summary
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Detailed Description
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The inclusion criteria are: patients aged 18-45 years, with full permanent dentition (excluding third molars), generalized spacing or spacing between anterior teeth, normal skeletal relationships, and Angle Class I or mild Class II malocclusions. Patients with the following criteria will be excluded: patients with missing or extracted permanent teeth (excluding third molars), periodontally compromised teeth, who need any form of hybrid orthodontic treatment (a fixed appliance with aligners), any signs or symptoms of temporomandibular disorders, severe Angle Class II or Class III malocclusions, crowding, and Class II or Class III skeletal discrepancy.
Methods:
1. Intraoral scans will be obtained for the upper and lower arches followed by a 3D simulation before treatment to check the biomechanics and movements of the treatment.
2. After setting up the 3D digital design for treatment, we will begin the fabrication of 3D printed aligners.
3. The patient will be instructed to use the aligner, and instructions will be given to the patient to put aligners in warm water before wearing them. This activates their shape memory allowing them to fit more easily and comfortably, thus reducing stress on the aligners.
4. The Patient will change the aligners every week according to the manufacturer's instructions and at the end of treatment, a new 3D scanning for the patient's dental arches will be taken to obtain the actual model after treatment.
5. The virtual pre-treatment model obtained before, and the actual post-treatment model will be exported as STL files and imported into digital software as virtual pre-treatment and actual post-treatment models.
6. The virtual pre-treatment, virtual and achieved post-treatment models will be superimposed digitally.
7. After superimposition, a 3D coordinate system will be generated for tooth movement measurements. After determining the reference points on the pre-treatment model, they will be transferred onto actual and virtual post-treatment models through tooth crown surface superimposition. The achieved and predicted changes in crown movement of the upper and lower incisors will be calculated.
All numerical data will be collected for statistical analysis.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patients with spacing
Patients will receive direct printed aligners to treat the spacing
Direct printed aligners
Direct printed aligners After intraoral scanning, patients will receive Direct printed aligners, each set will be changed after 10 days, till the patients finish their treatment, then a post intraoral scan will be taken from each patient.
Interventions
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Direct printed aligners
Direct printed aligners After intraoral scanning, patients will receive Direct printed aligners, each set will be changed after 10 days, till the patients finish their treatment, then a post intraoral scan will be taken from each patient.
Eligibility Criteria
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Inclusion Criteria
* Non- extraction treatment.
* Angle Class I or Class II dental malocclusion with generalized or localized anterior spacing.
* Normal probing depth.
Exclusion Criteria
* Crowding cases.
* Systemic diseases or medications that alter bone metabolism or tooth movement.
18 Years
45 Years
ALL
No
Sponsors
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Beni-Suef University
OTHER
British University In Egypt
OTHER
Suez Canal University
OTHER
Responsible Party
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rim fathalla
Rim Mohamed Fathalla Eissa
Principal Investigators
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Rim M Fathalla, PhD of Orthodontics
Role: PRINCIPAL_INVESTIGATOR
Suez Canal University
Locations
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Beni-Suef University
Banī Suwayf, , Egypt
British University in Egypt
Cairo, , Egypt
Suez Canal University
Ismailia, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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Hertan E, McCray J, Bankhead B, Kim KB. Force profile assessment of direct-printed aligners versus thermoformed aligners and the effects of non-engaged surface patterns. Prog Orthod. 2022 Nov 29;23(1):49. doi: 10.1186/s40510-022-00443-2.
Lee SY, Kim H, Kim HJ, Chung CJ, Choi YJ, Kim SJ, Cha JY. Thermo-mechanical properties of 3D printed photocurable shape memory resin for clear aligners. Sci Rep. 2022 Apr 15;12(1):6246. doi: 10.1038/s41598-022-09831-4.
McKay A, McCray J, Bankhead B, Lee MM, Miranda G, Adel SM, Kim KB. Forces and moments generated during extrusion of a maxillary central incisor with clear aligners: an in vitro study. BMC Oral Health. 2023 Jul 17;23(1):495. doi: 10.1186/s12903-023-03136-2.
Kravitz ND, Kusnoto B, Agran B, Viana G. Influence of attachments and interproximal reduction on the accuracy of canine rotation with Invisalign. A prospective clinical study. Angle Orthod. 2008 Jul;78(4):682-7. doi: 10.2319/0003-3219(2008)078[0682:IOAAIR]2.0.CO;2.
Weir T. Clear aligners in orthodontic treatment. Aust Dent J. 2017 Mar;62 Suppl 1:58-62. doi: 10.1111/adj.12480.
Other Identifiers
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#REC-FDBSU/06032025-02/AR
Identifier Type: -
Identifier Source: org_study_id
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