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Evaluation of Accuracy of 3D Printed Aligners in Comparison to Thermoformed Aligners in Orthodontic Patients

Assessment of the Accuracy of Tooth Movement of 3D Printed Versus Thermoformed Aligners in Patients With Lower Anterior Crowding: A Randomized Clinical Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07496892
Acronym
Aligner
Enrollment
28
Registered
2026-03-27
Start date
2026-04-01
Completion date
2026-09-20
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Anterior Crowding

Brief summary

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

DEVICE3d printed aligner

direct printed aligner will be used

conventional thermoformed aligner will be the gold standard

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
11 Years to 25 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
accuracy of tooth movement6 monthThe 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.

Secondary

MeasureTime frameDescription
Patient reported Pain6 monthPain 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026