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RECRUITING
NCT07637227
NA

Clinical Performance of Direct-Printed Versus Thermoformed Aligners

Sponsor: University of Baghdad

View on ClinicalTrials.gov

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

DEVICE

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).

DEVICE

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