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Clinical Performance of Direct-Printed Versus Thermoformed Aligners

5 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

34

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Iraq
      • Baghdad, Iraq, 10013
        • Reclutamento
        • Z Orchida Clinic
        • Contatto:
      • Baghdad, Iraq, 10047
        • Reclutamento
        • Orthodontic department, College of dentistry, university of Baghdad.
        • Contatto:
    • Bab Al-Muadham
      • Baghdad, Bab Al-Muadham, Iraq, 10047

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

Sì

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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).
Comparatore attivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Angular tooth movement tracking accuracy
Lasso di tempo: 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
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Clinical efficiency
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Baghdad

Investigatori

  • Direttore dello studio: Noor Muhammed Garma, Assistant Professor, University of Baghdad, College of Dentistry, Department of Orthodontic.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 settembre 2027

Completamento dello studio (Stimato)

1 ottobre 2027

Date di iscrizione allo studio

Primo inviato

23 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 giugno 2026

Primo Inserito (Effettivo)

9 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 1197426

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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