Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency
10 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
75
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.
Ubicaciones de estudio
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Kayseri
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Talas, Kayseri, Turquía (Türkiye), 38039
- Erciyes University Faculty of Dentistry
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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
Acepta Voluntarios Saludables
No
Descripción
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 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: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Grupo de control
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Experimental: Invisalign Palatal Expander
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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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Experimental: In-House Aligner (2-Day Protocol)
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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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Experimental: In-House Aligner (5-Day Protocol)
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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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Maxillary Transverse Dentoalveolar Dimension
Periodo de tiempo: 20 weeks
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20 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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White spot lesion incidence
Periodo de tiempo: 20 weeks
|
20 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Actual)
26 de mayo de 2025
Finalización primaria (Estimado)
1 de mayo de 2026
Finalización del estudio (Estimado)
1 de julio de 2026
Fechas de registro del estudio
Enviado por primera vez
3 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
10 de mayo de 2026
Publicado por primera vez (Actual)
14 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025/189
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
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
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