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Clinical Performance of Direct-Printed Versus Thermoformed Aligners

NCT07637227 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-06-09

No results posted yet for this study

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.

Conditions

  • Angle Class I Malocclusion
  • Dental Crowding
  • Tooth Spacing

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.

Sponsors & Collaborators

  • University of Baghdad

    lead OTHER

Principal Investigators

  • Noor Muhammed Garma, Assistant Professor · University of Baghdad, College of Dentistry, Department of Orthodontic.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-09-30
Completion
2027-10-31

Countries

  • Iraq

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07637227 on ClinicalTrials.gov