An interventional study of Direct-Printed Aligner and Thermoformed aligner in Angle Class I Malocclusion, Dental Crowding and Tooth Spacing, sponsored by University of Baghdad. Recruiting at 3 sites in Iraq. Open to participants aged 15 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by University of Baghdad · Not applicable, Interventional, and Treatment
The goal of this study is to evaluate and compare the clinical effectiveness of in-office directly 3D-printed clear aligners versus conventional multilayered thermoformed aligners.
The main question it aims to answer is:
Does the use of in-office direct-printed shape-memory aligners result in superior clinical effectiveness, compared to established multilayer thermoformed aligner systems?
Researchers will compare a Direct-Printed Aligner (DPA) group using Senertek Clear-A V2 resin to a Thermoformed Aligner (TFA) group using Zendura FLX multilayer sheets to see if the additive manufacturing process improves clinical outcomes and patient satisfaction.
Participants will:
This is a prospective, parallel-arm randomized controlled multi-center clinical trial, to assess and compare the clinical effectiveness of in-office 3D-printed clear aligners with multilayered thermoformed aligners.
The subject population for this study will be male and female subjects aged 16-30 years who have fully erupted permanent dentition and mild dental crowding or spacing.
Methodology:
Patients requiring orthodontic treatment are randomly allocated into two groups.
Experimental Group (DPA): Aligners are fabricated using additive manufacturing (direct 3D printing) with Senertek Clear-A V2 shape-memory resin. This process eliminates the intermediate physical model, potentially reducing cumulative manufacturing errors.
Control Group (TFA): Aligners are fabricated by thermoforming multilayered thermoplastic sheets (Zendura FLX) over 3D-printed resin molds.
Assessment:
Digital models (STL files) will be obtained at the start (T0) and at the end of the treatment (T1). These will be compared to the digital treatment plan (Tp) using 3D superimposition and trigonometric analysis. Stable anatomical structures, such as the palatal rugae, will serve as reference points for superimposition. The primary outcome is the "Tracking Accuracy Percentage," which measures how closely the actual clinical tooth movement matches the digitally predicted movement. Secondary outcomes include clinical efficiency, patient-reported pain levels, and Manufacturing complexity, including total fabrication time.
35 studies on the registry are indexed under Malocclusion, Angle Class I; 10 are open to participants now.
This study's planned enrollment of 34 is close to 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:
Participants in this group will receive clear aligners manufactured using in-office 3D printing technology. This arm tests the effectiveness of additive manufacturing and the shape-memory properties of the resin in achieving programmed tooth movements.
Device: Direct-Printed Aligner
Participants in this group will receive conventional clear aligners manufactured using the vacuum-forming (thermoforming) process. This arm serves as the gold standard to which the experimental 3D-printed aligners are compared.
Device: Thermoformed aligner
Participants in this group will receive clear aligner therapy fabricated via direct-printing, utilizing a specialized light-curable resin (Clear-A V2, Senertek, İzmir, Turkey).
Participants in this group will treated with clear aligners fabricated via the conventional indirect method, involving the thermoforming of thermoplastic sheets (Zendura FLX, Zendura dental, Fremont, California) over 3D-printed dental molds.
Angular tooth movement tracking accuracy
Digital models (Initial (T0), planned (Tp), and final (T1)) will be compared using trigonometry. Angular measurements of vestibulo-lingual tipping, mesio-distal tipping, and rotation, will be performed on the three digital casts that had been previously superimposed.
Time frame: The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
Linear tooth movement tracking accuracy
Evaluation of the tracking accuracy of linear tooth movements (in millimeters) by superimposing three-dimensional digital dental models across three therapeutic stages: Initial (T0), Planned (Tp), and Final (T1). Trigonometric spatial analysis will be executed on the superimposed digital casts to quantify the absolute positional discrepancy between the virtually planned tooth position and the actual clinically achieved position.
Time frame: The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
Clinical efficiency
The additional treatment time necessitated by refinements will be calculated and compared statistically between the study groups.
Time frame: The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
Evaluate degree of conversion
The relative concentration of unreacted aliphatic carbon double bonds will be evaluated by measuring the peak areas of the aliphatic C=C stretching vibrations (at 1634 cm -1 and 1620 cm-1) and the stable internal standard (N-H bending absorption at 1523 cm-1) via the tangent baseline technique. These distinct spectral values will be mathematically aggregated using the standard normalized ratio equation: DC (%)=\[1-(R cured/R monomer)\]×100. Unit of Measure, percentage (%) of converted double bonds.
Time frame: The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
Shape memory property
The percentage of shape recovery over time and the total deformation angles exhibited by both the direct-printed resin (Senertek Clear-A V2) and the thermoformed aligner sheets.Quantitative measurements will be recorded using a standardized thermo-mechanical bending test layout under controlled temperature intervals.
Time frame: 3 months
Color stability assessment
Optical transmittance will be measured across the visible light spectrum to evaluate and compare the transparency degradation and color stability of direct-printed versus thermoformed aligners before and after in vivo aging.
Time frame: The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
Manufacturing complexity and fabrication time
For each workflow, the total production time, hands-on labor, and material expenses will be recorded and analyzed.
Time frame: The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
Patient-Reported Treatment Discomfort
Patient-reported pain or discomfort evaluated on a standard horizontal Visual Analogue Scale (VAS) ranging from 0 (no pain) to 100 (severe pain). Unit of Measure, millimeters (mm) on a 100 mm scale.
Time frame: The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
Plan to share: No
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Start is estimated for Jun 2026; primary completion for Sep 2027, 15 months later.
Of 23 interventional studies with no phase under Malocclusion, Angle Class I, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 24. This study's planned 15 months is below that.
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