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临床试验/NCT04022252
NCT04022252Unknown不适用

Investigation of the Effects of Photobiomodulation Applications on Orthodontic Tooth Movement

University of Gaziantep0 个研究点目标入组 24 人开始时间: 2019年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
24
主要终点
Orthodontic tooth movement Change

研究概览

简要总结

Increasing the speed of orthodontic treatment is an emerging clinical problem and therefore the evaluation of the effects of photobiomodulation applications and methods on orthodontic tooth movement is considered as an important factor.

When literature studies are examined, different studies have been performed on Laser and LED applications, however, the lack of a study that evaluates and compares the effectiveness of these methods in terms of clinical and biochemical parameters.

The aim of this study is to compare the effects of laser and LED applications on tooth movement speed and to investigate the effects of these applications on the gingival fluid IL-8, OPG, RANKL. Total of 24 patients with maxillary first-premolar extraction orthodontic treatment will be included in this study, and this study will consist of 3 groups, Laser, LED and placebo group. The laser will be applied on days 0,3,7,14,21,28,35, take impression of teeth and gingival fluid samples will be collected in these days.

LED group will be given 10 minutes LED for 30 days, taken impression and DOS samples will be collected on specified days. In the placebo group, the non-active pulse laser light will be kept in the teeth and the patients will not know which group in they are. Thus, the psychological dimension of the applications will be eliminated. Sampling will be done for the placebo group on the days determined.

The investigator's project proposal consists of a total of 5 work packages; Determination of patient groups in the 1st stage and obtaining consent forms, 2nd stage Photobiomodulation applications (laser, LED, placebo application), 3rd stage orthodontic measurement and evaluation of these measurements 3D environment, taking gingival fluid samples in the 4th stage and evaluating them biochemically. In the 5th stage, statistical analysis and evaluation of the results will be done.

The data will be evaluated with SPSS 21.0.In this study, it is tried to reduce the time spent in the orthodontic treatment to close the extraction area. In this way, it will contribute to economy and time saving in terms of all orthodontic treatment physicians and physicians. It will illuminate the application of LED device which is more advantageous in terms of cost and space gain in clinical practice of physicians.

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
14 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • adequate oral hygiene
  • Class 2 malocclusion requiring upper-premolar extraction orthodontic treatment
  • lack of congenital missing teeth in upper jaw
  • no systemic disease

排除标准

  • patients who wish to discontinue treatment
  • patients who cannot provide oral hygiene

研究组 & 干预措施

Tooth Movement

Experimental

Canine distalization on premolar extracted patients

干预措施: Cheese dental laser (Device)

Tooth Movement

Experimental

Canine distalization on premolar extracted patients

干预措施: OrthoPulse (Device)

Tooth Movement

Experimental

Canine distalization on premolar extracted patients

干预措施: Placebo (Other)

Biochemistry measurements

Experimental

biochemistry analysis of IL-8, OPG, RANKL

干预措施: Cheese dental laser (Device)

Biochemistry measurements

Experimental

biochemistry analysis of IL-8, OPG, RANKL

干预措施: OrthoPulse (Device)

Biochemistry measurements

Experimental

biochemistry analysis of IL-8, OPG, RANKL

干预措施: Placebo (Other)

periodontal measurements

Experimental

gingival and plaque index, blooding on probing, pocket depth

干预措施: Cheese dental laser (Device)

periodontal measurements

Experimental

gingival and plaque index, blooding on probing, pocket depth

干预措施: OrthoPulse (Device)

periodontal measurements

Experimental

gingival and plaque index, blooding on probing, pocket depth

干预措施: Placebo (Other)

结局指标

主要结局

Orthodontic tooth movement Change

时间窗: 1st, 3rd, 7th, 14th, 21th, 28th, 35th day

Measurement of orthodontic tooth movement (mm)

次要结局

  • OPG Change(1st, 3rd, 7th, 14th, 21th, 28th, 35th day)
  • Bleeding on Probing Change(1st, 3rd, 7th, 14th, 21th, 28th, 35th day)
  • Gingival Index Change(1st, 3rd, 7th, 14th, 21th, 28th, 35th day)
  • Plaque Index Change(1st, 3rd, 7th, 14th, 21th, 28th, 35th day)
  • RANKL Change(1st, 3rd, 7th, 14th, 21th, 28th, 35th day)
  • IL-8 Change(1st, 3rd, 7th, 14th, 21th, 28th, 35th day)
  • Periodontal Pocket Depth Change(1st, 3rd, 7th, 14th, 21th, 28th, 35th day)

研究者

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

Merve Goymen

Head of Orthodontics

University of Gaziantep

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