Clinical Trial

Clinical Performance of Direct-Printed Versus Thermoformed Aligners

Recruiting
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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.
Trial Details
NCT Number NCT07637227
Lead Sponsor University of Baghdad
Conditions Angle Class I Malocclusion, Dental Crowding, Tooth Spacing
Enrollment 34 participants
Start Date 2026-06
Primary Completion 2027-09 (estimated)
Study Completion 2027-10 (estimated)
Updated on ClinicalTrials.gov 2026-06-09