Clinical Performance of Direct-Printed Versus Thermoformed Aligners
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ali Rahman Issa, PhD student
- Numéro de téléphone: 009647801218939
- E-mail: ali.hassan1902@codental.uobaghdad.edu.iq
Lieux d'étude
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Baghdad, Irak, 10013
- Recrutement
- Z Orchida Clinic
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Contact:
- Ali Rahman isaa
- Numéro de téléphone: 009647801218939
- E-mail: ali.abdolrahman@gmail.com
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Baghdad, Irak, 10047
- Recrutement
- Orthodontic department, College of dentistry, university of Baghdad.
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Contact:
- Ali Rahman Issa, PhD. student
- Numéro de téléphone: 009647801218939
- E-mail: ali.hassan1902@codental.uobaghdad.edu.iq
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Bab Al-Muadham
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Baghdad, Bab Al-Muadham, Irak, 10047
- Recrutement
- Specialized Dental Center for Prosthodontics and Orthodontics
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Contact:
- Ali Rahman Issa
- Numéro de téléphone: 009647801218939
- E-mail: ali.hassan1902@codental.uobaghdad.edu.iq
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
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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).
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Comparateur actif: 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.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Angular tooth movement tracking accuracy
Délai: The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
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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.
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The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
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Linear tooth movement tracking accuracy
Délai: The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
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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.
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The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Clinical efficiency
Délai: The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
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The additional treatment time necessitated by refinements will be calculated and compared statistically between the study groups.
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The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
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Evaluate degree of conversion
Délai: The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
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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.
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The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
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Shape memory property
Délai: 3 months
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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.
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3 months
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Color stability assessment
Délai: The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
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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.
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The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
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Manufacturing complexity and fabrication time
Délai: The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
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For each workflow, the total production time, hands-on labor, and material expenses will be recorded and analyzed.
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The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
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Patient-Reported Treatment Discomfort
Délai: The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
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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.
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The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Noor Muhammed Garma, Assistant Professor, University of Baghdad, College of Dentistry, Department of Orthodontic.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1197426
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Informations sur les médicaments et les dispositifs, documents d'étude
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