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Clinical Comparison of Clear Aligners and Fixed Appliances in Dental Anterior Open Bite

2026年8月20日 更新者:Othman Ahmed Othman、Sana'a University

Clinical Comparison of Clear Aligners and Fixed Orthodontic Appliances in the Treatment of Dental Anterior Open Bite in Adults: A Randomized Controlled Clinical Trial

Dental anterior open bite is a challenging orthodontic condition with a high risk of relapse in adults. This randomized controlled clinical trial aims to compare the effectiveness and post-treatment stability of in-house clear aligners versus fixed orthodontic appliances in treating adult patients aged 18-30 years with dental anterior open bite (0 to -4 mm).

A total of 46 eligible participants will be randomly allocated into two equal groups (23 treated with clear aligners and 23 with fixed appliances). Treatment outcomes, vertical dentoalveolar changes, and skeletal changes will be evaluated using digital intraoral scans, virtual model superimposition, and lateral cephalometric analysis. Following active treatment, an 8-month retention phase (bonded lingual retainer combined with a vacuum-formed retainer) and an 8-month post-retention follow-up phase will be implemented to comprehensively evaluate treatment stability and relapse tendency over a total observation period of 16 months.

研究概览

详细说明

Anterior open bite (AOB) in adults presents significant treatment challenges due to the absence of remaining growth and a high relapse tendency. While fixed orthodontic appliances remain the standard approach for vertical control, clear aligner therapy has gained popularity despite limited randomized controlled evidence regarding its long-term predictability and stability.

This study is designed as a single-center, parallel-group, randomized controlled clinical trial conducted at the Faculty of Dentistry, Sana'a University. Enrolled participants meet strict inclusion criteria: adult age (18-30 years), dental anterior open bite (0 to -4 mm), Class I malocclusion with normal molar relationships, non-extraction treatment requirements (crowding/spacing \le 4\text{ mm}), and good oral hygiene.

Participants in the Clear Aligner group receive fully digital in-house aligners fabricated using Zahndent intraoral scans, 3D Maestro setup software, Elegoo Saturn 4 Ultra 16K printing, and PETG thermoforming sheets (0.75-0.8 mm). Aligner mechanics include optimized attachments and medium power intermaxillary elastics (3-4.5 oz) worn 20-22 hours per day. Participants in the Fixed Appliance group are treated using 0.022-inch MBT prescription brackets with a two-segment arch mechanics approach (canine-to-canine anterior segment and premolar/molar posterior segment) combined with progressive wire sequencing and vertical elastics.

Primary and secondary outcomes-including overbite increase, cephalometric vertical changes, treatment efficiency, patient compliance, and satisfaction-will be recorded at baseline, post-treatment, after 8 months of retention, and after 8 months of post-retention follow-up.

研究类型

介入性

注册 (估计的)

46

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。

学习联系方式

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

不

描述

Inclusion Criteria:

Adult patients aged 18 to 30 years with fully erupted permanent dentition. Anterior open bite equal to or greater than 2 mm. Angle Class I malocclusion. Good oral hygiene and healthy periodontal status.

-

Exclusion Criteria:

  • Previous orthodontic treatment. Presence of craniofacial anomalies or cleft lip/palate. Active periodontal disease or severe bone loss. History of temporomandibular joint disorders (TMD). Systemic conditions or medications affecting bone metabolism and tooth movement.

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:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Clear Aligner Group
Participants receive in-house manufactured PETG clear aligners (0.75-0.8 mm) designed with 3D Maestro setup software and printed using Elegoo Saturn 4 Ultra 16K. Aligners are changed every 10-14 days, combined with optimized composite attachments and medium power intermaxillary vertical elastics (3-4.5 oz) worn 20-22 hours daily.
Thermoplastic clear aligners (PETG 0.75-0.8 mm) manufactured in-house for vertical open bite closure, combined with composite attachments and intermaxillary elastics.
其他名称:
  • PETG Aligners
有源比较器:Fixed Appliance Group
Participants receive conventional fixed orthodontic appliances with 0.022-inch MBT prescription brackets. Treatment utilizes a two-segment arch mechanics approach (canine-to-canine anterior segment and premolar/molar posterior segment) combined with progressive wire sequencing and intermaxillary vertical elastics.
Conventional 0.022-inch MBT prescription fixed brackets utilizing two-segment arch mechanics and intermaxillary vertical elastics.

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
Overbite Change
大体时间:Baseline (T0) and completion of active treatment (T1, approximately 12-18 months)
Changes in anterior vertical overlap measured in millimeters on 3D digital dental models from baseline to the end of active treatment.
Baseline (T0) and completion of active treatment (T1, approximately 12-18 months)

次要结果测量

结果测量
措施说明
大体时间
Cephalometric Skeletal Changes
大体时间:Baseline and through study completion, an average of 18 months
Changes in vertical and sagittal skeletal relationships (SN-GoGn angle, measured in degrees) evaluated on lateral cephalometric radiographs.
Baseline and through study completion, an average of 18 months
Cephalometric Dental Changes
大体时间:Baseline and through study completion, an average of 18 months
Changes in upper and lower incisor inclinations (U1-SN and L1-MP angles, measured in degrees) evaluated on lateral cephalometric radiographs.
Baseline and through study completion, an average of 18 months

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:Ghamdan Al-Harazi, PhD、Sana'a University

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 (估计的)

2026年11月1日

初级完成 (估计的)

2028年3月1日

研究完成 (估计的)

2029年7月1日

研究注册日期

首次提交

2026年8月17日

首先提交符合 QC 标准的

2026年8月20日

首次发布 (实际的)

2026年8月21日

研究记录更新

最后更新发布 (实际的)

2026年8月21日

上次提交的符合 QC 标准的更新

2026年8月20日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data will not be shared to protect participant privacy and confidentiality.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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