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Clinical Performance of Direct-Printed Versus Thermoformed Aligners

5. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

34

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Irak
      • Baghdad, Irak, 10013
      • Baghdad, Irak, 10047
        • Rekrutierung
        • Orthodontic department, College of dentistry, university of Baghdad.
        • Kontakt:
    • Bab Al-Muadham
      • Baghdad, Bab Al-Muadham, Irak, 10047

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Gerät: 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).
Aktiver Komparator: 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.
Gerät: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Angular tooth movement tracking accuracy
Zeitfenster: 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
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Clinical efficiency
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Baghdad

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

1. September 2027

Studienabschluss (Geschätzt)

1. Oktober 2027

Studienanmeldedaten

Zuerst eingereicht

23. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. Juni 2026

Zuerst gepostet (Tatsächlich)

9. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 1197426

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Ja

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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