Clear Aligners vs Fixed Appliances for Molar Distalization Using Infrazygomatic Crest Screws
15. července 2026 aktualizováno: Ahmet Yağcı, TC Erciyes University
Evaluation of the Treatment Effects of Different Clear Aligner and Fixed Appliance Systems in Maxillary Posterior Distalization Using Infrazygomatic Crest Screws: An In-Vivo Randomized Clinical Study
This study compares three different methods of moving upper back teeth backward (distalization) to create space for crowded or protruding teeth, all supported by small temporary screws placed in the cheekbone area (infrazygomatic crest screws).
Participants were randomly assigned to one of three treatment types: traditional fixed braces (Pitts21 system), Invisalign clear aligners, or ClearCorrect clear aligners.
The study measures how effectively each method moves the back teeth, how long treatment takes, and how comfortable and practical each method is for patients.
The goal is to help orthodontists and patients choose the most effective and efficient treatment option for this type of tooth movement.
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
This prospective randomized clinical trial included 35 subjects aged 13-18 years with skeletal Class I, dental Class II malocclusion, randomly allocated to Pitts21 fixed appliance (n=12), Invisalign (n=12), or ClearCorrect (n=11) treatment groups.
Unilateral or bilateral infrazygomatic crest (IZC) miniscrews were placed in all subjects, and distalization forces were applied via intraoral elastics.
Lateral cephalometric radiographs and digital dental models (acquired with a 3Shape TRIOS 3 intraoral scanner) were obtained at the start (T0) and end (T1) of distalization to assess skeletal, dental, and soft tissue changes.
Patient-reported outcomes were also collected, including pain (Visual Analog Scale) and anxiety (Çapa Anxiety Scale).
Data were analyzed using IBM SPSS v23 and R 4.4.1;
normality was assessed with the Shapiro-Wilk test.
Between-group comparisons used one-way ANOVA or the Kruskal-Wallis H test, and within-group comparisons over time used paired t-test, Wilcoxon, repeated measures ANOVA, or Friedman test.
Group×time and group×tooth interactions were evaluated using Generalized Estimating Equations and Robust Mixed ANOVA, with Bonferroni, Games-Howell, or Holm corrections applied for multiple comparisons.
Typ studie
Intervenční
Zápis (Aktuální)
37
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Kayseri, Turecko (Türkiye), 38000
- Erciyes University, Faculty of Dentistry, Department of Orthodontics
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
Inclusion Criteria:
- Skeletal Class I (ANB angle 0-4°), dental Class II malocclusion treatable with molar distalization
- Need for unilateral or bilateral distalization of the first molars in the range of 2-4.5 mm
- Chronological age between 13 and 18 years, regardless of skeletal age
- Normal or hypodivergent growth pattern (SN-GoGn < 39°)
- Mild to moderate maxillary crowding (less than 6 mm) and minimal or no mandibular crowding (less than 3 mm)
- No previously extracted maxillary teeth, excluding third molars
- Erupted permanent second molars
- Good oral hygiene
- Healthy periodontal tissues
Exclusion Criteria:
- Need for orthodontic tooth extraction or functional appliance therapy
- Presence of systemic disease
- Congenital or acquired craniofacial deformity involving the condyle or mandible
- Poor patient cooperation
- History of allergy to any metal
- Pre-existing root resorption prior to treatment
- Previous orthodontic treatment
- Abnormal position, depth of impaction, or close proximity to adjacent anatomical structures (sinus, neurovascular structures) of the maxillary third molar that would make its surgical extraction risky
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: Group A ( Pitts21® Fixed Appliance )
Participants received maxillary posterior distalization using the Pitts21® fixed orthodontic appliance system, anchored with infrazygomatic crest (IZC) miniscrews and intraoral elastics for distalization force.
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Fixed orthodontic brackets (Pitts21 system) used for maxillary posterior distalization, anchored with infrazygomatic crest miniscrews and intraoral elastics.
Ostatní jména:
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Experimentální: Group B ( Invisalign® clear aligners)
Participants received maxillary posterior distalization using Invisalign® clear aligners, anchored with infrazygomatic crest (IZC) miniscrews and intraoral elastics for distalization force.
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Clear aligner system (Invisalign) used for maxillary posterior distalization, anchored with infrazygomatic crest miniscrews and intraoral elastics.
Ostatní jména:
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Experimentální: Group C ( ClearCorrect® clear aligners)
Participants received maxillary posterior distalization using ClearCorrect® clear aligners, anchored with infrazygomatic crest (IZC) miniscrews and intraoral elastics for distalization force.
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Clear aligner system (ClearCorrect) used for maxillary posterior distalization, anchored with infrazygomatic crest miniscrews and intraoral elastics.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Amount of Maxillary Posterior Tooth Distalization
Časové okno: From the date of infrazygomatic crest miniscrew placement and initiation of distalization force (T0) until the end of the active distalization phase (T1), assessed up to 13 months
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The amount of distalization of the maxillary premolars and molars (U4, U5, U6, U7) was measured in millimeters using three-dimensional digital dental model analysis, comparing pre-treatment (T0) and post-distalization (T1) records.
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From the date of infrazygomatic crest miniscrew placement and initiation of distalization force (T0) until the end of the active distalization phase (T1), assessed up to 13 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Total Distalization Duration
Časové okno: From the date of miniscrew placement and start of distalization force (T0) until the date of completion of active distalization (T1), assessed up to 13 months
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The total duration of the distalization phase, calculated as the time interval between the start of force application (T0) and the completion of active distalization (T1).
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From the date of miniscrew placement and start of distalization force (T0) until the date of completion of active distalization (T1), assessed up to 13 months
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Distalization Efficacy in Clear Aligner Groups
Časové okno: From treatment planning (T0) until the end of active distalization (T1), assessed up to 13 months
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Distalization efficacy was calculated as the ratio of achieved to planned tooth movement (Efficacy = Achieved/Planned × 100), based on digital treatment planning, for the Invisalign and ClearCorrect groups.
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From treatment planning (T0) until the end of active distalization (T1), assessed up to 13 months
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Infrazygomatic Crest Miniscrew Success Rate
Časové okno: From the date of miniscrew placement until the end of active distalization, assessed up to 13 months
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The success rate of infrazygomatic crest miniscrews used for anchorage was recorded, defined as the proportion of miniscrews remaining stable and functional throughout the distalization period without requiring replacement.
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From the date of miniscrew placement until the end of active distalization, assessed up to 13 months
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Cephalometric Skeletal, Dental, and Soft Tissue Changes
Časové okno: From the date of miniscrew placement and start of distalization force (T0) until the end of active distalization (T1), assessed up to 13 months
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Skeletal, dental, and soft tissue changes were assessed using lateral cephalometric radiographs, comparing measurements obtained at the beginning (T0) and end (T1) of distalization.
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From the date of miniscrew placement and start of distalization force (T0) until the end of active distalization (T1), assessed up to 13 months
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Rotation of Premolars and Molars During Distalization
Časové okno: From T0 to T1, assessed up to 13 months
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Changes in the rotational position of the maxillary premolars and molars (U4-U7) were measured using digital dental models, comparing T0 and T1 records.
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From T0 to T1, assessed up to 13 months
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Mesiodistal Tipping of Premolars and Molars During Distalization
Časové okno: From T0 to T1, assessed up to 13 months
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Changes in mesiodistal crown angulation (tipping) of the maxillary premolars and molars (U4-U7) were measured using digital dental models, comparing T0 and T1 records.
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From T0 to T1, assessed up to 13 months
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Transverse Width Changes in the Maxillary Posterior Region
Časové okno: From T0 to T1, assessed up to 13 months
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Changes in transverse arch width at the level of the premolars and molars (U4-U7) were measured using digital dental models, comparing T0 and T1 records.
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From T0 to T1, assessed up to 13 months
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Pain Level Assessed by Visual Analog Scale
Časové okno: From day 1 after miniscrew placement/appliance activation up to the end of active distalization, assessed at 5 time points (day 1, week 1, month 1, month 3, and end of distalization; up to 13 months)
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Pain associated with treatment was assessed using the Visual Analog Scale (VAS, 0-10) at multiple time points: day 1, week 1, month 1, month 3, and end of distalization.
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From day 1 after miniscrew placement/appliance activation up to the end of active distalization, assessed at 5 time points (day 1, week 1, month 1, month 3, and end of distalization; up to 13 months)
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Anxiety Level Assessed by the Çapa Anxiety Scale
Časové okno: From day 1 after miniscrew placement/appliance activation up to the end of active distalization, assessed at 5 time points (day 1, week 1, month 1, month 3, and end of distalization; up to 13 months)
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Patient anxiety related to treatment was assessed using the Çapa Anxiety Scale at multiple time points: day 1, week 1, month 1, month 3, and end of distalization.
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From day 1 after miniscrew placement/appliance activation up to the end of active distalization, assessed at 5 time points (day 1, week 1, month 1, month 3, and end of distalization; up to 13 months)
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
6. června 2024
Primární dokončení (Aktuální)
12. ledna 2026
Dokončení studie (Aktuální)
18. února 2026
Termíny zápisu do studia
První předloženo
15. července 2026
První předloženo, které splnilo kritéria kontroly kvality
15. července 2026
První zveřejněno (Aktuální)
20. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
20. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
15. července 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Klíčová slova
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- TDH-2025-15402
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