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临床试验/NCT07390357
NCT07390357已完成不适用

Effect of 635-nm Photobiomodulation on Orthodontic Tooth Movement: a Randomized Split-mouth Clinical Trial

Wroclaw Medical University1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2021年1月5日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
18
试验地点
1
主要终点
Amount of maxillary canine tooth movement

研究概览

简要总结

This study evaluated whether photobiomodulation (PBM), a form of low-level light therapy, can accelerate orthodontic tooth movement during canine distalization in adult patients undergoing fixed orthodontic treatment.

Eighteen adult patients requiring extraction of maxillary first premolars as part of orthodontic treatment for Class II malocclusion were enrolled. The study used a randomized, controlled, split-mouth design, in which one side of the maxilla was randomly assigned to receive PBM therapy, while the contralateral side served as an untreated control. This design allowed each participant to act as their own control.

All patients underwent standard orthodontic treatment with fixed appliances and absolute anchorage provided by orthodontic mini-implants. Canine distalization was performed using nickel-titanium closed-coil springs delivering comparable orthodontic forces on both sides. Photobiomodulation was applied on the experimental side using a 635-nm diode laser according to a predefined schedule over a 45-day period, while no laser treatment was applied on the control side.

The primary outcome was the amount of canine tooth movement, measured in millimeters at baseline and at follow-up visits using a calibrated orthodontic caliper. Tooth movement on the laser-treated side was compared with movement on the control side over time.

The purpose of this study was to determine whether photobiomodulation could safely and effectively increase the rate of orthodontic tooth movement without additional surgical intervention or pharmacological treatment.

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
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 years or older
  • Class II malocclusion requiring extraction of maxillary first premolars
  • Indication for maxillary canine distalization with absolute anchorage
  • Fixed orthodontic treatment for the first time
  • Good general health
  • Non-smokers
  • Good periodontal health
  • Ability to understand the study procedures and provide written informed consent

排除标准

  • Uncontrolled periodontal disease
  • Systemic diseases or conditions affecting bone metabolism
  • Diabetes mellitus or other metabolic disorders
  • Pregnancy or breastfeeding
  • History of radiotherapy or bisphosphonate therapy
  • Use of systemic anti-inflammatory drugs or antibiotics within the previous 12 months
  • Poor oral hygiene

研究组 & 干预措施

Photobiomodulation-treated side

Experimental

One side of the maxilla randomly assigned to receive photobiomodulation therapy during orthodontic canine distalization. This side received standard fixed orthodontic treatment with absolute anchorage provided by orthodontic mini-implants, combined with 635-nm photobiomodulation therapy applied according to the study protocol.

干预措施: 635-nm photobiomodulation (Device)

Sham photobiomodulation-treated side

Placebo Comparator

The contralateral side of the maxilla that served as the control. This side underwent the same orthodontic treatment protocol and mechanics as the experimental side. A sham photobiomodulation procedure was performed by placing the laser handpiece in contact with the tissues without light emission, simulating the intervention without delivering therapeutic laser energy.

干预措施: Sham photobiomodulation (Device)

结局指标

主要结局

Amount of maxillary canine tooth movement

时间窗: Baseline (Day 0) to Day 45

The amount of orthodontic canine tooth movement was assessed by measuring the linear distance between the central points of the bracket slots bonded to the maxillary canine and first premolar. Measurements were performed using a calibrated orthodontic caliper at baseline (Day 0) and at follow-up visits up to Day 45. Tooth movement was calculated as the change in distance over time.

次要结局

未报告次要终点

研究者

发起方
Wroclaw Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jacek Matys

Principal Investigator

Wroclaw Medical University

研究点 (1)

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