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临床试验/NCT04044989
NCT04044989已完成不适用

Placebo-Controlled, Randomized, Double Blind Trial of Effect of Photobiomodulation Therapies On The Root Resorption Associated With Orthodontic Forces: A Pilot Study Using Micro Computed Tomography

University of Gaziantep1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年1月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Root Resorption

研究概览

简要总结

Objectives: The aim of this study is to investigate the effect of photobiomodulation therapies on root resorption compared with the placebo group. Materials and Methods: 30 patients, who were admitted to the ............. University Faculty of Dentistry Orthodontics Department for treatment, with an indication of upper right 1st premolar tooth extraction was included. Before the individuals' orthodontic treatment, 0.022 slot MBT brackets and tubes were placed on the maxillary 1st premolar and molar. A 150g buccal tipping force was applied to the 1st premolar. Individuals were then randomly divided into 3 groups. For the first group; laser application was performed with a 810 nm GaAlAs laser device at 0,3,7,14,21 and 28 days to 8 J/cm2. Second group; an LED application according to the manufacturer's instructions with a 850 nm wavelength and 20 mW/cm2 output power for 10 minutes per day during the experiment. Third group; a placebo therapy was completed whereby a laser device that did not make active pulses was used. At the end of four weeks, the amount of root surface resorption was compared using micro-CT imaging after the extraction of the teeth.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
15 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • No history of orthodontic treatment
  • No systemic disease or craniofacial anomaly
  • No dental trauma and tooth with root resorption
  • Having good oral hygiene
  • No periodontal disease (no more than 3mm pocket)
  • No restored or endodontically untreated upper right 1st premolar teeth
  • Having the maxillary right 1st premolar tooth extraction indication of orthodontic treatment

排除标准

  • Problems in patient compliance
  • Inadequate oral hygiene
  • Development of any medical problem making orthodontic treatment contraindicated during the study period

研究组 & 干预措施

Root resorption (total)

Experimental

The resorption cavities on the root surface were determined and the volumes of the cavities were measured in CTAn software (micro-CT).

干预措施: Laser (Device)

Root resorption (total)

Experimental

The resorption cavities on the root surface were determined and the volumes of the cavities were measured in CTAn software (micro-CT).

干预措施: light-emitting diode (LED) (Device)

Root resorption (total)

Experimental

The resorption cavities on the root surface were determined and the volumes of the cavities were measured in CTAn software (micro-CT).

干预措施: Placebo (Device)

Root resorption (local)

Experimental

The resorption cavities on the root surface (palatal, buccal, distal and mesial root surfaces) were determined and the volumes of the cavities were measured in CTAn software (micro-CT).

干预措施: Laser (Device)

Root resorption (local)

Experimental

The resorption cavities on the root surface (palatal, buccal, distal and mesial root surfaces) were determined and the volumes of the cavities were measured in CTAn software (micro-CT).

干预措施: light-emitting diode (LED) (Device)

Root resorption (local)

Experimental

The resorption cavities on the root surface (palatal, buccal, distal and mesial root surfaces) were determined and the volumes of the cavities were measured in CTAn software (micro-CT).

干预措施: Placebo (Device)

结局指标

主要结局

Root Resorption

时间窗: through study completion, an average of 4 weeks

Crater volume measurement

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Merve Goymen

Asisst. Prof.

University of Gaziantep

研究点 (1)

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