RecruitingNot ApplicableNCT07637227

Clinical Performance of Direct-Printed Versus Thermoformed Aligners

Clinical Performance of In-Office Directly Printed Versus Thermoformed Aligners: A Randomized Clinical Trial


Sponsor

University of Baghdad

Enrollment

34 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 15 YearsMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Direct-Printed Aligner and a medical device called Thermoformed aligner for people with angle class i malocclusion, dental crowding, and other related conditions. The study is currently recruiting participants at 3 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEDirect-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).

DEVICEThermoformed 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

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NCT07637227


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