NCT07350343

The Predictability of Directly Printed Versus Thermoformed Clear Aligners

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: University of Baghdad · Academic / Other
• Sex: All
• Age: 16 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

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°.

Conditions

• Class I Malocclusion
• Crowded Teeth
• Spacing of Anterior Teeth
• Rotation

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2026-02-15
• Primary completion: 2027-04-01
• Completion: 2027-06-01
• First posted: 2026-01-20
• Last updated: 2026-04-15

Locations

1 site across 1 country: Iraq