Clinical Performance of Direct-Printed Versus Thermoformed Aligners

NCT07637227 | Recruiting

• 1 other identifier: 1197426
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 3

Brief 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; Tooth Spacing; Dental Crowding

Keywords

In office aligners; 3D printed aligners; Thermoformed Aligners; Tooth movement; Photopolymer Resin; Pain

Outcome Measures

Primary Outcomes (2)

• Angular tooth movement tracking accuracy

  Digital models (Initial (T0), planned (Tp), and final (T1)) will be compared using trigonometry. Angular measurements of vestibulo-lingual tipping, mesio-distal tipping, and rotation, will be performed on the three digital casts that had been previously superimposed.

  The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.

• Linear tooth movement tracking accuracy

  Evaluation of the tracking accuracy of linear tooth movements (in millimeters) by superimposing three-dimensional digital dental models across three therapeutic stages: Initial (T0), Planned (Tp), and Final (T1). Trigonometric spatial analysis will be executed on the superimposed digital casts to quantify the absolute positional discrepancy between the virtually planned tooth position and the actual clinically achieved position.

  The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.

Secondary Outcomes (6)

• Clinical efficiency

  The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.

• Evaluate degree of conversion

  The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.

• Shape memory property

  3 months

• Color stability assessment

  The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.

• Manufacturing complexity and fabrication time

  The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.

Study Arms (2)

Direct-Printed Aligner

EXPERIMENTAL

Participants in this group will receive clear aligners manufactured using in-office 3D printing technology. This arm tests the effectiveness of additive manufacturing and the shape-memory properties of the resin in achieving programmed tooth movements.

Device: Direct-Printed Aligner

Thermoformed Aligner

ACTIVE COMPARATOR

Participants in this group will receive conventional clear aligners manufactured using the vacuum-forming (thermoforming) process. This arm serves as the gold standard to which the experimental 3D-printed aligners are compared.

Device: Thermoformed aligner

Interventions

Direct-Printed Aligner DEVICE

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).

Direct-Printed Aligner

Thermoformed aligner DEVICE

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.

Thermoformed Aligner

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adult patient with an age range of 15-30 with fully erupted all permanent dentitions excluding third molars, and a willingness to participate in the trial.
• Angle Class I non-extraction cases, presented with mild crowding or spacing (\<5 mm) and dental rotation \<30° .
• Good oral hygiene; no active caries/periodontal disease, no history of trauma or root resorption.

You may not qualify if:

• Pregnancy, smoking, and systemic conditions affecting bone remodeling.
• Subject with poor oral hygiene, using simplified oral hygiene index (OHI-S ≥ 3.1 ) (Greene \& Vermillion, 1963).
• Patient with malposed lower second molars (need orthodontic alignment).
• Allergy to materials used (resins, plastics, solvents).
• History of trauma, root resorption, and dilacerated roots.
• Previous extraction or history of previous orthodontic treatment.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (3)

Specialized Dental Center for Prosthodontics and Orthodontics

Baghdad, Bab Al-Muadham, 10047, Iraq

RECRUITING

Z Orchida Clinic

Baghdad, 10013, Iraq

RECRUITING

Orthodontic department, College of dentistry, university of Baghdad.

Baghdad, 10047, Iraq

RECRUITING

MeSH Terms

Conditions

Malocclusion, Angle Class I; Crowding; Pain

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases; Spatial Behavior; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Noor Muhammed Garma, Assistant Professor

  University of Baghdad, College of Dentistry, Department of Orthodontic.

  STUDY DIRECTOR

Central Study Contacts

Ali Rahman Issa, PhD student

CONTACT

009647801218939; ali.hassan1902@codental.uobaghdad.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer, PhD student

Study Record Dates

• First Submitted: May 23, 2026
• First Posted: June 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IR (3)