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Clinical Performance of Direct-Printed Versus Thermoformed Aligners
Sponsor: University of Baghdad
Summary
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.
Official title: Clinical Performance of In-Office Directly Printed Versus Thermoformed Aligners: A Randomized Clinical Trial
Key Details
Gender
All
Age Range
15 Years - 30 Years
Study Type
INTERVENTIONAL
Enrollment
34
Start Date
2026-06
Completion Date
2027-10
Last Updated
2026-06-09
Healthy Volunteers
Yes
Interventions
Direct-Printed 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).
Thermoformed aligner
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.
Locations (3)
Specialized Dental Center for Prosthodontics and Orthodontics
Baghdad, Bab Al-Muadham, Iraq
Z Orchida Clinic
Baghdad, Iraq
Orthodontic department, College of dentistry, university of Baghdad.
Baghdad, Iraq