Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency
10 mai 2026 mis à jour par: Celal Irgin, TC Erciyes University
Comparison of the Effectiveness of Different Clear Aligner Systems in Patients With Maxillary Transverse Deficiency During the Mixed Dentition Period: An In-Vivo Randomized Controlled Clinical Trial
he primary aim of this study is to compare the dentoalveolar and skeletal effects of arch expansion using an in-house clear aligner system, produced chairside with an indirect manufacturing technique, and commercially available clear aligner systems (Invisalign) in patients during the mixed dentition period.
Participants will be allocated into five groups: Group A-In-house aligners (5-day activation protocol), Group B-In-house aligners (2-day activation protocol), Group C-Invisalign First aligners, Group D-Invisalign Palatal Expander, and Group E-untreated control group.
Before treatment, demographic data, dental models, intraoral and extraoral photographs, radiographic images, and clinical measurements will be collected. Skeletal measurements, including maxillary and nasal widths, will be evaluated using posteroanterior cephalometric radiographs. Digital models of the maxilla and mandible will be obtained using an intraoral scanner and used for dental measurements before and after treatment.
Secondary outcomes include evaluation of facial soft tissue changes using stereophotogrammetry (3DMD), assessment of white spot lesions using quantitative light-induced fluorescence (QLF), and analysis of patient compliance using the Orthodontic Patient Cooperation Scale. In addition, changes in body mass index (BMI), maxillary-mandibular transverse discrepancies, and appliance wear time will be evaluated.
Aperçu de l'étude
Statut
Actif, ne recrute pas
Les conditions
Type d'étude
Interventionnel
Inscription (Réel)
75
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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-
Kayseri
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Talas, Kayseri, Turquie (Türkiye), 38039
- Erciyes University Faculty of Dentistry
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Patients in the early mixed dentition period;
- Maxillary intermolar width ≤ 31 mm;
- Presence of at least 5 mm transverse discrepancy between the maxillary and mandibular arches;
- Normal vertical growth pattern (Sn-GoGn: 32 ± 6°);
- Eruption of permanent first molars and central incisors;
- Presence of at least two primary posterior teeth in each quadrant;
- Posterior teeth with a clinical crown height of at least 4 mm;
- Patients aged between 7 and 10 years;
- Absence of any craniofacial anomalies;
- Good oral hygiene status; Healthy periodontal tissues.
Exclusion Criteria:
- Patients with the loss of more than one primary tooth
- Presence of stainless steel crowns on the maxillary permanent first molars, primary first molars, or primary second molars
- Patients with systemic or syndromic conditions
- Presence of palatal exostoses or morphological anomalies of the palatal surface
- Presence of active temporomandibular joint disorders
- Children with poor compliance
- History of allergy to any dental material
- Patients with multiple and/or advanced caries, tooth agenesis, or supernumerary teeth
- Patients with skeletal asymmetry
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: Groupe de contrôle
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|
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Expérimental: Invisalign Palatal Expander
|
In patients treated with the Invisalign Palatal Expander (IPE) (Align Technology, Santa Clara, CA), three-dimensional digital models were obtained using an intraoral scanner (iTero Lumina™, Align Technology).
Individualized maxillary expansion amounts were prescribed based on clinical objectives.
Unlike conventional aligner therapy, the IPE system does not involve full digital treatment simulation; expansion was defined by the planned transverse increase.
Following approval, customized IPE appliance sets were manufactured and delivered.
Patients were instructed to wear the appliance full-time, including during meals, removing it only for oral hygiene procedures.
The activation protocol consisted of appliance changes every 2 days, providing 0.25 mm transverse expansion per stage.
After completion of expansion, retention was achieved using Invisalign Palatal Holder appliances fabricated from new digital scans.
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Expérimental: In-House Aligner (2-Day Protocol)
|
In-house clear aligners were fabricated using a fully digital workflow.
Digital impressions were obtained with an intraoral scanner (3Shape TRIOS), and maxillary models were processed in CAD software for segmentation and attachment planning.
Buccal retention attachments were placed on primary canines, primary molars, and permanent first molars.
Maxillary models were digitally expanded in 0.2 mm increments per stage, generating sequential STL files.
Models were 3D-printed and thermoformed to fabricate aligners, which were then trimmed, polished, and labeled.
Patients received five aligners at each visit and were instructed to change them every 2 days.
Follow-up visits were scheduled at 10-day intervals.
At each visit, treatment progress was assessed, and the next series of aligners was provided.
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Expérimental: In-House Aligner (5-Day Protocol)
|
In-house clear aligners were fabricated using a fully digital workflow.
Digital impressions were obtained with an intraoral scanner (3Shape TRIOS), and maxillary models were processed in CAD software for segmentation and attachment planning.
Buccal retention attachments were placed on primary canines, primary molars, and permanent first molars to enhance retention and support transverse expansion.
Models were digitally expanded in 0.2 mm increments per stage and converted into sequential STL files.
These models were 3D-printed (Asiga MAX UV) and thermoformed (MINISTAR S) to produce aligners.
The appliances were trimmed, polished, and labeled with sequence numbers.
Patients received five aligners per visit and were instructed to change them every 5 days.
Follow-up visits were scheduled at 25-day intervals, during which treatment progress was evaluated and new aligners were delivered.
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Comparateur actif: Invisalign First Aligner
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In patients treated with Invisalign First (Align Technology, Santa Clara, CA), three-dimensional digital models were obtained using an intraoral scanner (3Shape TRIOS).
Intraoral, extraoral photographs and radiographs were collected and uploaded to the ClinCheck digital treatment planning platform.
Individualized treatment objectives were defined, and expansion was planned without concurrent tooth movement to isolate maxillary transverse effects.
After achieving the desired expansion, comprehensive orthodontic treatment was continued.
Virtual treatment plans were reviewed and revised when necessary before approval.
Attachments were placed on posterior teeth to enhance retention and support expansion.
Enamel surfaces were etched, bonded, and light-cured using standard orthodontic protocols.
Patients were instructed to wear aligners 20-22 hours daily,and aligners were replaced every 5 days.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Maxillary Transverse Dentoalveolar Dimension
Délai: 20 weeks
|
20 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
White spot lesion incidence
Délai: 20 weeks
|
20 weeks
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
26 mai 2025
Achèvement primaire (Estimé)
1 mai 2026
Achèvement de l'étude (Estimé)
1 juillet 2026
Dates d'inscription aux études
Première soumission
3 mai 2026
Première soumission répondant aux critères de contrôle qualité
10 mai 2026
Première publication (Réel)
14 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
10 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025/189
Plan pour les données individuelles des participants (IPD)
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INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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