Evaluation of Accuracy of 3D Printed Aligners in Comparison to Thermoformed Aligners in Orthodontic Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 3d printed aligner, thermoformed aligner.
- Who it may be relevant to
- Registry conditions: Lower Anterior Crowding. Basic parameters: 11 years — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Assessment of the Accuracy of Tooth Movement of 3D Printed Versus Thermoformed Aligners in Patients With Lower Anterior Crowding: A Randomized Clinical Trial
Overview
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.
Detailed description
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.
Interventions
- Device 3d printed aligner
direct printed aligner will be used - Device thermoformed aligner
conventional thermoformed aligner will be the gold standard
Primary outcome measures
- accuracy of tooth movement [Time frame: 6 month]
Secondary outcome measures (1)
- Patient reported Pain [Time frame: 6 month]
Eligibility criteria
Inclusion criteria
- Non-extraction orthodontic treatment cases
- Mild to moderate lower anterior crowding (<5 mm)
- Age between 12 and 25 years
- Dental rotation less than 30 degrees
- Relapse cases with crowding less than 5 mm
Exclusion criteria
- Active or history of periodontal disease
- Presence of systemic disease
- Temporomandibular joint disorders (TMJ)
- Missing teeth
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Oral and Dental Medicine — Cairo
Publications
- 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. PMID 38800861
- 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. PMID 25412265
- Kesling HD. The philosophy of tooth positioning appliance. Am J Orthod Oral Surg. 1945;31:297-304.
Identifiers
NCT: NCT07496892 · 30-12-2025