Clear Aligners vs Fixed Appliances for Molar Distalization Using Infrazygomatic Crest Screws
2026年7月15日 更新者：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.
調査の概要
状態
完了
条件
詳細な説明
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.
研究の種類
介入
入学 (実際)
37
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Kayseri、トルコ（Türkiye）、38000
- Erciyes University, Faculty of Dentistry, Department of Orthodontics
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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.
他の名前：
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実験的：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.
他の名前：
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実験的：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Amount of Maxillary Posterior Tooth Distalization
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Total Distalization Duration
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Distalization Efficacy in Clear Aligner Groups
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2024年6月6日
一次修了 (実際)
2026年1月12日
研究の完了 (実際)
2026年2月18日
試験登録日
最初に提出
2026年7月15日
QC基準を満たした最初の提出物
2026年7月15日
最初の投稿 (実際)
2026年7月20日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月20日
QC基準を満たした最後の更新が送信されました
2026年7月15日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- TDH-2025-15402
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