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Clinical Performance of Direct-Printed Versus Thermoformed Aligners

5 de junio de 2026 actualizado por: Ali Rahman Issa, University of Baghdad

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

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

This is a prospective, parallel-arm randomized controlled multi-center clinical trial, to assess and compare the clinical effectiveness of in-office 3D-printed clear aligners with multilayered thermoformed aligners.

The subject population for this study will be male and female subjects aged 16-30 years who have fully erupted permanent dentition and mild dental crowding or spacing.

Methodology:

Patients requiring orthodontic treatment are randomly allocated into two groups.

Experimental Group (DPA): Aligners are fabricated using additive manufacturing (direct 3D printing) with Senertek Clear-A V2 shape-memory resin. This process eliminates the intermediate physical model, potentially reducing cumulative manufacturing errors.

Control Group (TFA): Aligners are fabricated by thermoforming multilayered thermoplastic sheets (Zendura FLX) over 3D-printed resin molds.

Assessment:

Digital models (STL files) will be obtained at the start (T0) and at the end of the treatment (T1). These will be compared to the digital treatment plan (Tp) using 3D superimposition and trigonometric analysis. Stable anatomical structures, such as the palatal rugae, will serve as reference points for superimposition. The primary outcome is the "Tracking Accuracy Percentage," which measures how closely the actual clinical tooth movement matches the digitally predicted movement. Secondary outcomes include clinical efficiency, patient-reported pain levels, and Manufacturing complexity, including total fabrication time.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

34

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Irak
      • Baghdad, Irak, 10013
        • Reclutamiento
        • Z Orchida Clinic
        • Contacto:
      • Baghdad, Irak, 10047
        • Reclutamiento
        • Orthodontic department, College of dentistry, university of Baghdad.
        • Contacto:
    • Bab Al-Muadham
      • Baghdad, Bab Al-Muadham, Irak, 10047
        • Reclutamiento
        • Specialized Dental Center for Prosthodontics and Orthodontics
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto

Acepta Voluntarios Saludables

Sí

Descripción

Inclusion Criteria:

  1. 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.
  2. Angle Class I non-extraction cases, presented with mild crowding or spacing (<5 mm) and dental rotation <30° .
  3. Good oral hygiene; no active caries/periodontal disease, no history of trauma or root resorption.

Exclusion Criteria:

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Direct-Printed Aligner
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.
Dispositivo: 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).
Comparador activo: Thermoformed Aligner
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.
Dispositivo: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Angular tooth movement tracking accuracy
Periodo de tiempo: The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
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
Periodo de tiempo: The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Clinical efficiency
Periodo de tiempo: The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
The additional treatment time necessitated by refinements will be calculated and compared statistically between the study groups.
The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
Evaluate degree of conversion
Periodo de tiempo: The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
The relative concentration of unreacted aliphatic carbon double bonds will be evaluated by measuring the peak areas of the aliphatic C=C stretching vibrations (at 1634 cm -1 and 1620 cm-1) and the stable internal standard (N-H bending absorption at 1523 cm-1) via the tangent baseline technique. These distinct spectral values will be mathematically aggregated using the standard normalized ratio equation: DC (%)=[1-(R cured/R monomer)]×100. Unit of Measure, percentage (%) of converted double bonds.
The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
Shape memory property
Periodo de tiempo: 3 months
The percentage of shape recovery over time and the total deformation angles exhibited by both the direct-printed resin (Senertek Clear-A V2) and the thermoformed aligner sheets.Quantitative measurements will be recorded using a standardized thermo-mechanical bending test layout under controlled temperature intervals.
3 months
Color stability assessment
Periodo de tiempo: The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
Optical transmittance will be measured across the visible light spectrum to evaluate and compare the transparency degradation and color stability of direct-printed versus thermoformed aligners before and after in vivo aging.
The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
Manufacturing complexity and fabrication time
Periodo de tiempo: The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
For each workflow, the total production time, hands-on labor, and material expenses will be recorded and analyzed.
The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
Patient-Reported Treatment Discomfort
Periodo de tiempo: The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
Patient-reported pain or discomfort evaluated on a standard horizontal Visual Analogue Scale (VAS) ranging from 0 (no pain) to 100 (severe pain). Unit of Measure, millimeters (mm) on a 100 mm scale.
The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Baghdad

Investigadores

  • Director de estudio: Noor Muhammed Garma, Assistant Professor, University of Baghdad, College of Dentistry, Department of Orthodontic.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de junio de 2026

Finalización primaria (Estimado)

1 de septiembre de 2027

Finalización del estudio (Estimado)

1 de octubre de 2027

Fechas de registro del estudio

Enviado por primera vez

23 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

5 de junio de 2026

Publicado por primera vez (Actual)

9 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

5 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 1197426

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

Sí

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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