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Two Low-level Laser Irradiation Protocols on the Rate of Canine Retraction

2021年6月11日 更新者:Hams Hamed Abdelrahman

The Effect of Two Low-level Laser Irradiation Protocols on the Rate of Canine Retraction (a Randomized Controlled Clinical Trial)

Several methods aiming at the acceleration of orthodontic tooth movement have been proposed, including low-level laser therapy (LLLT), which showed promising results. However, the frequency of patient recall has been one of its major drawbacks.

研究概览

详细说明

A randomized controlled clinical trial will be conducted to address the aim of the study. Sixteen patients will be recruited, requiring the therapeutic extraction of the maxillary 1st premolars, with subsequent canine retraction into the extraction space. The sample will be randomly divided into 2 equal groups, each including 8 subjects.

In Group A, one side of the maxillary arch will randomly receive LLLT on days 0, 3, 7, 14, and every 2 weeks thereafter, while in Group B, one side will also be randomly chosen to receive LLLT every 3 weeks. The contralateral sides of both groups will serve as the controls. The LLLT applied will be Diode laser emitting infrared radiation at wavelength of 980 nm, in a continuous mode.

Canine retraction in both groups will be carried out bilaterally using nickel-titanium closed-coil spring, delivering 150 grams of force, and the rate of tooth movement will be checked every 3 weeks, over a period of 3 months. Other variables will be also examined including, interleukin-1β level in the gingival crevicular fluid, root resorption, and molar anchorage loss.

研究类型

介入性

注册 (预期的)

16

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

      • Alexandria、埃及
        • Alexandria Faculty of Dentistry

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

15年 至 25年 (孩子、成人)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Malocclusion requires at least the extraction of maxillary first premolars, followed by canine retraction into the extraction site.
  • Normal shape and structure of the maxillary canines, with no history of root canal treatment.
  • Patients with good oral hygiene, and a healthy periodontal condition.

Exclusion Criteria:

  • Patients who underwent previous orthodontic treatment.
  • Patients currently receiving drug therapy that may affect orthodontic tooth movement, e.g. hormonal therapy and corticosteroids.
  • Patients with chronic diseases that may affect the rate of tooth movement.
  • Pregnancy and lactation

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
实验性的:low-level laser therapy applied on days 0, 3,7,14 & every 2 weeks
one side of the maxillary arch will randomly receive LLLT on days 0, 3, 7, 14, and every 2 weeks thereafter and the contralateral side will serve as the controls.
有源比较器:low-level laser therapy applied every 3 weeks
one side will also be randomly chosen to receive LLLT every 3 weeks and the contralateral side will serve as the controls.

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 rate of canine retraction
大体时间:at baseline and every 3 weeks for 3 months
Several landmarks will be identified on the dental cast, including the mid-palatal raphe, the most medial points on the third right and left rugae, and the cusp tips of the right and left maxillary canines. Perpendicular lines will be drawn from the medial points of the right and left third rugae, and the cusp tips of the right and left maxillary canines to the mid-palatal raphe. The antero-posterior measurements will be carried out between the canine lines and the third rugae lines bilaterally, to assess the rate of canine retraction.
at baseline and every 3 weeks for 3 months
change in IL-1β level in the Ginigval Crevicular Fluid
大体时间:at baseline, 7th, 17th and 21st day
Samples from the GCF will be collected at baseline (before the first canine retraction), in addition to days 7, 14, and 21. GCF samples will be collected from the distal crevices of the canines, in Groups A and B, on both the experimental and control sides. Measurement of IL-1β level in the GCF will be performed using an ELISA kit.
at baseline, 7th, 17th and 21st day

次要结果测量

结果测量
措施说明
大体时间
change canine root resorption:
大体时间:at baseline and 3 months
Root resorption of the maxillary canines will be evaluated and measured on the acquired pre-retraction and post-retraction CBCT scans.
at baseline and 3 months
Change molar anchorage loss
大体时间:at baseline and every 3 weeks for 3 months
Perpendicular lines will be drawn from the central fossae of both maxillary right and left first molars to the mid-palatal raphe. Consequently, molar anchorage loss will be calculated by measuring the distance between those lines, and the lines representing the third rugae as previously mentioned.
at baseline and every 3 weeks for 3 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。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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)

2020年1月1日

初级完成 (预期的)

2021年6月15日

研究完成 (预期的)

2021年6月15日

研究注册日期

首次提交

2021年6月3日

首先提交符合 QC 标准的

2021年6月11日

首次发布 (实际的)

2021年6月15日

研究记录更新

最后更新发布 (实际的)

2021年6月15日

上次提交的符合 QC 标准的更新

2021年6月11日

最后验证

2021年6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

  • Canine retraction 2020

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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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