An interventional study of Direct-printed aligner (Graphy) and Thermoformed aligner in Class I Malocclusion, Crowded Teeth and Spacing of Anterior Teeth, sponsored by University of Baghdad. Enrolling by invitation at 1 site in Iraq. Open to participants aged 16 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by University of Baghdad · Not applicable, Interventional, and Treatment
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.
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°.
35 studies on the registry are indexed under Malocclusion, Angle Class I; 10 are open to participants now.
This study's planned enrollment of 36 is above the median of 32 across 31 interventional studies indexed under Malocclusion, Angle Class I.
Browse Malocclusion, Angle Class I studies →University of Baghdad is the lead sponsor of 170 studies on the registry; 69 are open to participants now.
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Exclusion Criteria:
Patients will be treated with direct-printed Graphy aligners until dental levelling alignment; space closure is finished.
Device: Direct-printed aligner (Graphy)
Patients will be treated with thermoformed aligners until dental alignment, levelling, space closure is finished.
Device: Thermoformed aligner
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.
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.
predictability of tooth movement
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 (%).
Time frame: 12 months
predictability within different types
1\. The secondary outcome will be assessed by comparing the predictability within different types of tooth movement of the same group.
Time frame: 12 months
Colour change of clear aligners
UV-Visible spectrophotometer for samples from both groups before and after intraoral aging.
Time frame: 12 months
Degree of Conversion
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.
Time frame: 12 months
shape memory effect
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.
Time frame: 12 months
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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