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.
研究概览
地位
完全的
详细说明
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.
研究类型
介入性
注册 (实际的)
37
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
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Kayseri、土耳其（türkiye）、38000
- Erciyes University, Faculty of Dentistry, Department of Orthodontics
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：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.
其他名称：
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实验性的：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.
其他名称：
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实验性的：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.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Amount of Maxillary Posterior Tooth Distalization
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Total Distalization Duration
大体时间：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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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Distalization Efficacy in Clear Aligner Groups
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2024年6月6日
初级完成 (实际的)
2026年1月12日
研究完成 (实际的)
2026年2月18日
研究注册日期
首次提交
2026年7月15日
首先提交符合 QC 标准的
2026年7月15日
首次发布 (实际的)
2026年7月20日
研究记录更新
最后更新发布 (实际的)
2026年7月20日
上次提交的符合 QC 标准的更新
2026年7月15日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他研究编号
- TDH-2025-15402
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
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不
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