Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency
10 mei 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Actief, niet wervend
Conditie
Studietype
Ingrijpend
Inschrijving (Werkelijk)
75
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Kayseri
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Talas, Kayseri, Turkije (Türkiye), 38039
- Erciyes University Faculty of Dentistry
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Geen tussenkomst: Controlegroep
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Experimenteel: 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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Experimenteel: 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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Experimenteel: 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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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Maxillary Transverse Dentoalveolar Dimension
Tijdsspanne: 20 weeks
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20 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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White spot lesion incidence
Tijdsspanne: 20 weeks
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20 weeks
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
26 mei 2025
Primaire voltooiing (Geschat)
1 mei 2026
Studie voltooiing (Geschat)
1 juli 2026
Studieregistratiedata
Eerst ingediend
3 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
10 mei 2026
Eerst geplaatst (Werkelijk)
14 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
14 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
10 mei 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2025/189
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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