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NCT Number: NCT07496892

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

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.

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Key information

Age range

11 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Oral and Dental Medicine

Cairo, Cairo Governorate, 12613, Egypt

Location contact

Farouk Khaled Ismail, Postgraduate

CONTACT

[email protected]

00201002487056

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3d printed aligner

Device

direct printed aligner will be used

Thermoformed aligner

Device

conventional thermoformed aligner will be the gold standard

Primary outcomes

  1. accuracy of tooth movement

    Time frame: 6 month

    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.

Secondary outcomes

  1. Patient reported Pain

    Time frame: 6 month

    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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Acronym: Aligner

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.