Clinical Performance of Direct-Printed Versus Thermoformed Aligners
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-30
SponsorUniversity of Baghdad
About this trial
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:
* Undergo initial records including intraoral digital scans, photos, and a panoramic radiograph for treatment planning. * Wear their assigned clear aligners (either direct-printed or thermoformed) for at least 22 hours per day, changing them every 7 days. * Attend follow-up appointments every 5 weeks.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adult patient with an age range of 15-30 with fully erupted all permanent dentitions excluding third molars, and a willingness to participate in the trial.
Angle Class I non-extraction cases, presented with mild crowding or spacing (<5 mm) and dental rotation <30° .
Good oral hygiene; no active caries/periodontal disease, no history of trauma or root resorption.
Disqualifiers
Pregnancy, smoking, and systemic conditions affecting bone remodeling.
Subject with poor oral hygiene, using simplified oral hygiene index (OHI-S ≥ 3.1 ) (Greene & Vermillion, 1963).
Patient with malposed lower second molars (need orthodontic alignment).
Allergy to materials used (resins, plastics, solvents).
Trial design
Design model
Parallel
Treatments tested in this trial
Direct-Printed Aligner
DeviceParticipants in this group will receive clear aligner therapy fabricated via direct-printing, utilizing a specialized light-curable resin (Clear-A V2, Senertek, İzmir, Turkey).
Thermoformed aligner
DeviceParticipants 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.
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: Direct-Printed AlignerExperimental treatment 1 intervention
Group B: Thermoformed AlignerActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.2
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.Secondary outcomes
1
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.2
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.3
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 months4
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.Sponsors and contacts
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Source ClinicalTrials.gov