Bone Level Changes Using Clear Aligners Compared to Fixed Appliances in Non-Extraction Treatment of Adults
2026年7月15日 更新者：Ahmed Mohamed Hesham、Future University in Egypt
Evaluation of Bone Level Changes Using Clear Aligners Compared to Fixed Appliances in Non-extraction Treatment of Adult Patients: A Randomized Clinical Trial
This study compares two common ways of straightening teeth in adults who have mild-to-moderate crowding of the lower front teeth and do not need any teeth removed: clear aligners and traditional fixed braces.
The main aim is to find out whether the two methods differ in how they affect the bone that surrounds the teeth. Using three-dimensional X-ray scans (cone-beam CT) and digital models of the teeth taken before and during treatment, the researchers measure the level and thickness of the bone around the lower front teeth, the tilt (inclination) of the lower front teeth, and how quickly the crowding is corrected.
Adults are randomly assigned to receive either clear aligners or fixed braces, and the same measurements are compared between the two groups over about six months.
研究概览
研究类型
介入性
注册 (实际的)
20
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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Cairo、埃及、11865
- Faculty of Oral and Dental Medicine, Future University in Egypt (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
- 成人
接受健康志愿者
是的
描述
Inclusion Criteria:
- Adults 18-25 years of age, of both sexes.
- Mild-to-moderate mandibular anterior crowding (2-6 mm).
- Angle Class I molar relationship with normal overjet (1-3 mm) and overbite (1-2 mm).
- Full permanent dentition with a healthy periodontium.
- Normal anteroposterior and vertical skeletal pattern.
Exclusion Criteria:
- Any local or systemic condition, or trauma, capable of affecting craniofacial growth and development.
- History of previous orthodontic or interceptive treatment.
- Loss of periodontal attachment.
- Craniofacial anomalies, facial asymmetry or skeletal discrepancy.
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：Fixed appliances (Group FA)
Conventional pre-adjusted edgewise fixed appliance (0.022-inch slot, MBT prescription) bonded from first molar to first molar; levelling and alignment with a sequence of nickel-titanium and stainless-steel archwires over approximately six months.
|
Brackets bonded first-molar-to-first-molar; alignment sequence 0.014" NiTi → 0.016" NiTi → 0.016 × 0.022" NiTi → 0.017 × 0.025" stainless steel.
Interproximal reduction performed on assigned contacts where indicated.
其他名称：
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实验性的：Clear aligners (Group CA)
Three-dimensionally printed, thermoformed clear aligners with bonded attachments and interproximal reduction as indicated; worn ~22 hours/day and changed per the digital staging, with clinical review every four weeks over approximately six months
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Digital intraoral scan and staging (3Shape Ortho Analyzer); 3D-printed models thermoformed into aligners; attachments bonded where planned; sequential aligners worn ~22 h/day.
Interproximal reduction per contact from canine-to-canine is done.
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 |
|---|---|---|
|
Change in alveolar bone level
大体时间：Baseline (T0) and end of alignment phase (T3)) (approximately 6 months)
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Change (mm) in the distance from the cemento-enamel junction to the alveolar crest on the labial and lingual aspects of the mandibular central incisors, lateral incisors and canines, measured on CBCT (OnDemand software), calculated as the difference between baseline and end-of-alignment values.
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Baseline (T0) and end of alignment phase (T3)) (approximately 6 months)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in alveolar bone thickness
大体时间：Baseline (T0) and end of alignment phase (≈ 6 months)
|
Change (mm) in labial and lingual alveolar bone thickness measured at 3 mm and 6 mm from the CEJ and at the root apex of the mandibular central incisors, lateral incisors and canines on CBCT (OnDemand software), from baseline to end of alignment.
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Baseline (T0) and end of alignment phase (≈ 6 months)
|
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Change in mandibular incisor inclination (torque)
大体时间：Baseline (T0) and end of alignment phase (≈ 6 months)
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Change (degrees) in the inner angle between the long axis of each mandibular central incisors, lateral incisors and canines and the mandibular plane, measured on the sagittal view of CBCT (Invivo/Anatomage software), from baseline to end of alignment.
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Baseline (T0) and end of alignment phase (≈ 6 months)
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Rate of alignment (Little's Irregularity Index)
大体时间：Baseline (T0), 8 weeks (T1), 16 weeks (T2) and end of alignment (T3, ≈ 24 weeks / 6 months)
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Reduction in mandibular anterior crowding quantified by Little's Irregularity Index (mm) - the sum of the displaced anatomic contact points from canine to canine - measured on serial digital models; the change across time points and the percentage improvement from baseline describe the rate of alignment.
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Baseline (T0), 8 weeks (T1), 16 weeks (T2) and end of alignment (T3, ≈ 24 weeks / 6 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。
调查人员
- 首席研究员：ahmed mohamed hesham elzoghary、Faculty of Oral and Dental Medicine, Future University in Egypt
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8月15日
初级完成 (实际的)
2025年7月25日
研究完成 (实际的)
2026年4月15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21日
研究记录更新
最后更新发布 (实际的)
2026年7月21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
关键字
其他研究编号
- FUE.REC (18)/7-2024
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
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研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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