The Predictability of Directly Printed Versus Thermoformed Clear Aligners

April 11, 2026 updated by: Hussin Anwar, University of Baghdad

The Predictability of Directly Printed Shape Memory (Graphy) Versus Thermoformed Clear Aligners: A Randomized Clinical Trial

The study is randomized controlled trial ...The null hypothesis suggests that there is no significant difference between actual and predicted dental movement in patients treated using direct printed aligners produced with Graphy™ Tera Harz TA-28 resin as compared to those treated with thermoformed clear aligners.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

the patients will be randomly assigned to one of two study groups which either direct printed or thermoformed clear aligner. All patients would be given the same instructions: aligners had to be worn for at least 22 hours per day, except during meals and oral hygiene activities, and should be changed every 10 days.Teeth positions would be planned according to esthetic and functional principles, starting with the 3D T0 digital model and aligning and leveling dental arches following orthodontic aligner biomechanical principles. Each aligner had a planned movement speed of 0.2 mm linear displacement, 2° long-axis rotation, and a vestibulo-lingual inclination of 2.5°.

Study Type

Interventional

Enrollment (Estimated)

36

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

  • Iraq
      • Karbala, Iraq
        • The sample will be recruited from multicentre clinics (Private dental clinic, Orthodontic Department at Karbala Governmental Specialized Dental Centre, Orthodontic Department, College of Dentistry University of Baghdad).

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:

  • Patients with mild to moderate malocclusion that can be treated by less than 40 steps of aligner treatment, including those with dental rotation of < 30°, diastema or crowding of < 8 mm.
  • Patients aged ≥ 16 years with fully erupted permanent teeth (regardless of the third molar).
  • No supernumerary teeth, no enamel malformation.
  • No tooth shape anomalies

Exclusion Criteria:

  • Systemic pathologies such as uncontrolled diabetes or heart diseases
  • active or past periodontal disease
  • previous orthodontic treatment
  • temporomandibular joint disorders
  • ongoing pharmacological treatment could influence orthodontic treatment.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Direct-printed aligner (Graphy)
Patients will be treated with direct-printed Graphy aligners until dental levelling alignment; space closure is finished.
Device: Direct-printed aligner (Graphy)
intraoral scanner would be used to scan patient teeth then aligner fabrication by direct printing then the patient will be treated with direct-printed aligners(graphy) until dental levelling alignment; space closure is finished. All patients would be given the same instructions: aligners had to be worn for at least 22 hours per day, except during meals and oral hygiene activities, and should be changed every 10 days.
Active Comparator: Thermoformed aligner
Patients will be treated with thermoformed aligners until dental alignment, levelling, space closure is finished.
Device: Thermoformed aligner
An intraoral scanner would be used to scan patient teeth then aligner fabrication by thermoforming then the Patients will be treated with thermoformed aligners until dental alignment, levelling, space closure is finished. All patients would be given the same instructions: aligners had to be worn for at least 22 hours per day, except during meals and oral hygiene activities, and should be changed every 10 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
predictability of tooth movement
Time Frame: 12 months
The primary outcome will be calculated as the percentage difference between the final and initial positions for each individual tooth movement assessed and will be expressed as a continuous numerical variable representing tooth movement predictability (%).
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
predictability within different types
Time Frame: 12 months
1. The secondary outcome will be assessed by comparing the predictability within different types of tooth movement of the same group.
12 months
Colour change of clear aligners
Time Frame: 12 months
UV-Visible spectrophotometer for samples from both groups before and after intraoral aging.
12 months
Degree of Conversion
Time Frame: 12 months
Assessment of the Degree of Conversion of direct printed Tera Harz TA-28 resin using Fourier-transform infrared (FTIR) spectroscopy for the liquid resin before curing and for samples after curing and post-processing.
12 months
shape memory effect
Time Frame: 12 months
Assessment of the shape memory effect of direct printed Tera Harz TA-28 aligners, the bending test would be used to investigate and directly visualize the shape recovery property.
12 months

Collaborators and Investigators

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

Sponsor

University of Baghdad

Investigators

  • Principal Investigator: hussin anwar, University of Baghdad

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 (Actual)

February 15, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

January 13, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 11, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1154425

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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