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

March 23, 2026 updated by: Farouk Khaled, Cairo University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 12613

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3D printed aligner
Participants will receive orthodontic treatment using directly 3D printed aligners fabricated with shape memory resin.
Device: 3d printed aligner
direct printed aligner will be used
Active Comparator: thermoformed aligner
Participants will receive orthodontic treatment using conventional thermoformed aligners fabricated using vacuum forming techniques.
Device: thermoformed aligner
conventional thermoformed aligner will be the gold standard

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Migliorati M et al. Accuracy of orthodontic movements with 3D printed aligners: A prospective observational pilot study. Korean J Orthod. 2024;54(3):160-170.
  • 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;85(5):881-889.
  • Kesling HD. The philosophy of tooth positioning appliance. Am J Orthod Oral Surg. 1945;31:297-304.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 20, 2026

Study Registration Dates

First Submitted

March 17, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 30-12-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The plan for sharing individual participant data is currently under consideration. Any data sharing will comply with institutional policies and participant confidentiality requirements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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