Clear Aligners vs Fixed Appliances for Molar Distalization Using Infrazygomatic Crest Screws
15. Juli 2026 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
37
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Kayseri, Türkei (türkiye), 38000
- Erciyes University, Faculty of Dentistry, Department of Orthodontics
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: 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.
Andere Namen:
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Experimental: 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.
Andere Namen:
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Experimental: 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.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Amount of Maxillary Posterior Tooth Distalization
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Total Distalization Duration
Zeitfenster: 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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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Distalization Efficacy in Clear Aligner Groups
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
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Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
6. Juni 2024
Primärer Abschluss (Tatsächlich)
12. Januar 2026
Studienabschluss (Tatsächlich)
18. Februar 2026
Studienanmeldedaten
Zuerst eingereicht
15. Juli 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
15. Juli 2026
Zuerst gepostet (Tatsächlich)
20. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
20. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
15. Juli 2026
Zuletzt verifiziert
1. Juli 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- TDH-2025-15402
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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