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Digital vs. Conventional Indirect Bonding.

2026年7月8日 更新者:Azienda Ospedaliero-Universitaria Careggi

Comparison of Indirect Bonding of Orthodontic Brackets Using Digital Versus Conventional Technology: A Randomized Controlled Trial on Bonding Time and Bracket Failure

This randomized split-mouth clinical trial will compare digital and conventional indirect bonding techniques for fixed orthodontic bracket placement in adolescent patients requiring treatment in both dental arches.

Each participant will receive both bonding techniques, with allocation of the digital and conventional indirect bonding procedures to the upper or lower arch determined by randomization. The study will evaluate the time required to complete bracket bonding procedures and the early clinical performance of the two techniques, assessed by bracket failure within the first month after appliance placement.

研究概览

详细说明

Indirect bonding has been proposed as an alternative to direct bonding for the placement of orthodontic brackets, with potential advantages in terms of clinical efficiency, bracket positioning, and patient comfort. In recent years, computer-aided three-dimensional design and manufacturing methods have enabled the production of digital transfer trays for indirect bonding, offering a potentially more standardized workflow compared with conventional laboratory-based procedures.

This randomized split-mouth clinical trial will compare digital and conventional indirect bonding techniques in patients undergoing fixed orthodontic treatment in both the upper and lower arches. Each participant will receive both techniques, with the allocation of the digital and conventional bonding procedures to the upper or lower arch determined by randomization.

In the digital indirect bonding procedure, transfer trays will be produced using a digital workflow and brackets will be bonded using a pre-coated adhesive system. In the conventional indirect bonding procedure, transfer trays will be produced using a standard laboratory workflow and brackets will be bonded using a conventional orthodontic adhesive system.

The study will assess the procedural efficiency of the two techniques by recording the time required to complete the bracket bonding procedure. Early clinical performance will be evaluated by recording bracket failures during the first month of orthodontic treatment. All procedures and follow-up assessments will be performed in a clinical orthodontic setting.

研究类型

介入性

注册 (估计的)

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。

学习联系方式

学习地点

      • Florence、意大利
        • 招聘中
        • Orthodontic Clinic, Division of Dentistry, Careggi University Hospital
        • 接触:

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:

  • Patients aged 12 to 18 years requiring fixed orthodontic treatment on both upper and lower arches
  • Presence of full permanent dentition, including erupted second molars

Exclusion Criteria:

  • Presence of dental anomalies in number (supernumerary or missing teeth) in either arch
  • Orthodontic treatment plans involving tooth extractions in either arch
  • Nickel allergy
  • History of cleft lip and/or palate
  • Craniofacial syndromes

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:Digital indirect bonding in the upper arch and conventional indirect bonding in the lower arch
Participants assigned to this arm will receive digital indirect bonding in the upper arch and conventional indirect bonding in the lower arch.
Fixed orthodontic appliance will be bonded using a digital indirect bonding technique
Fixed orthodontic appliance will be bonded using a conventional indirect bonding technique
有源比较器:Conventional indirect bonding in the upper arch and digital indirect bonding in the lower arch
Participants assigned to this arm will receive conventional indirect bonding in the upper arch and digital indirect bonding in the lower arch.
Fixed orthodontic appliance will be bonded using a digital indirect bonding technique
Fixed orthodontic appliance will be bonded using a conventional indirect bonding technique

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
Time required to complete bracket bonding procedures, measured in minutes
大体时间:During procedure (from the beginning of bracket bonding to completion of bracket placement)
The time required to complete the bracket bonding procedure will be measured in minutes for each participant, from the beginning of the bonding procedure to completion of bracket placement, using the assigned adhesive system.
During procedure (from the beginning of bracket bonding to completion of bracket placement)

次要结果测量

结果测量
措施说明
大体时间
Bracket failure rate within the first month of orthodontic treatment assessed by clinical examination
大体时间:1 month after placement of the fixed orthodontic appliance
Bracket failure will be assessed by clinical examination and recorded as the number of brackets detached from the tooth surface within the first month after placement of the fixed orthodontic appliance.
1 month after placement of the fixed orthodontic appliance

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)

2025年9月3日

初级完成 (估计的)

2026年7月20日

研究完成 (估计的)

2026年8月24日

研究注册日期

首次提交

2025年4月23日

首先提交符合 QC 标准的

2026年7月8日

首次发布 (实际的)

2026年7月9日

研究记录更新

最后更新发布 (实际的)

2026年7月9日

上次提交的符合 QC 标准的更新

2026年7月8日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • LF17

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

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

在美国制造并从美国出口的产品

不

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