Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency
10 maggio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Attivo, non reclutante
Condizioni
Tipo di studio
Interventistico
Iscrizione (Effettivo)
75
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.
Luoghi di studio
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Kayseri
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Talas, Kayseri, Turchia (Türkiye), 38039
- Erciyes University Faculty of Dentistry
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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
Accetta volontari sani
No
Descrizione
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
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: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Nessun intervento: Gruppo di controllo
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Sperimentale: 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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Sperimentale: 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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Sperimentale: 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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Maxillary Transverse Dentoalveolar Dimension
Lasso di tempo: 20 weeks
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20 weeks
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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White spot lesion incidence
Lasso di tempo: 20 weeks
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20 weeks
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
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 (Effettivo)
26 maggio 2025
Completamento primario (Stimato)
1 maggio 2026
Completamento dello studio (Stimato)
1 luglio 2026
Date di iscrizione allo studio
Primo inviato
3 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
10 maggio 2026
Primo Inserito (Effettivo)
14 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
14 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
10 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2025/189
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
INDECISO
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
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 .
Prove cliniche su Invisalign Palatal Expander Therapy
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Büşra Zeynep YörükCenterdent Orthodontics & Aesthetic Dentistry ClinicReclutamento