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The goal of this randomized clinical trial is to compare the accuracy of tooth movement achieved by 3D printed aligners versus thermoformed aligners in patients with lower anterior crowding. The study aims to evaluate whether directly printed aligners provide more accurate and predictable orthodontic tooth movement compared to conventional thermoformed aligners.
Recently, a new resin for 3D direct printed aligners (DPA) has been introduced. This resin, characterized by its viscoelastic properties, allows for precise control over material dimensions, structure, and properties. This enables the aligners to exert constant and gradual forces within the physiological limits of tooth movements .
Tera Harz Tc-58, a new direct-printed resin material introduced by Graphy Company, exhibits a significant shape memory effect. Approximately 90% of the deformation is recovered within 10 minutes, while 96% recovered after 60 minutes, whereas PETG maintains its deformed shape and shows no shape recovery.
DPA shows a significant enhancement in treating different moderate malocclusion cases by reducing the peer assessment rating (PAR) score by 86% and also reducing the need for attachment which simplifies treatment.
This study aims to determine the accuracy of DPA in facilitating tooth movement and to identify which types of tooth movements are more accurately achieved with DPA compared to conventional aligners.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D printed aligner | Experimental | Participants will receive orthodontic treatment using directly 3D printed aligners fabricated with shape memory resin. |
|
| thermoformed aligner | Active Comparator | Participants will receive orthodontic treatment using conventional thermoformed aligners fabricated using vacuum forming techniques. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3d printed aligner | Device | direct printed aligner will be used |
| |
| Measure | Description | Time Frame |
|---|---|---|
| accuracy of tooth movement | The accuracy of tooth movement will be assessed by comparing the predicted tooth position from the digital treatment plan (TP) with the actual post-treatment position (T1) using 3D superimposition techniques. Measurements will include linear and angular differences for each tooth using digital software analysis. | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported Pain | Pain levels will be evaluated using a Visual Analogue Scale questionnaire completed by participants during aligner therapy. its score from 1 to 10 in which score 10 is the worst pain level | 6 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Oral and Dental Medicine | Cairo | Cairo Governorate | 12613 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38800861 | Background | Migliorati M, Drago S, Castroflorio T, Pesce P, Battista G, Campobasso A, Gastaldi G, Valvecchi FF, Mari A. Accuracy of orthodontic movements with 3D printed aligners: A prospective observational pilot study. Korean J Orthod. 2024 May 25;54(3):160-170. doi: 10.4041/kjod23.268. Epub 2024 Apr 8. | |
| 25412265 | Background |
| Label | URL |
|---|---|
| Related Info | View source |
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The plan for sharing individual participant data is currently under consideration. Any data sharing will comply with institutional policies and participant confidentiality requirements.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Dec 30, 2025 | Mar 23, 2026 | Prot_SAP_ICF_000.pdf |
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| thermoformed aligner |
| Device |
conventional thermoformed aligner will be the gold standard |
|
| Rossini G, Parrini S, Castroflorio T, Deregibus A, Debernardi CL. Efficacy of clear aligners in controlling orthodontic tooth movement: a systematic review. Angle Orthod. 2015 Sep;85(5):881-9. doi: 10.2319/061614-436.1. Epub 2014 Nov 20. |
| Background | Kesling HD. The philosophy of tooth positioning appliance. Am J Orthod Oral Surg. 1945;31:297-304. |