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临床试验/NCT07810699
NCT07810699招募中不适用

Comparative Effects of Diode Laser and LED Photobiomodulation on Maxillary Canine Retraction During Orthodontic Treatment

Can Tho University of Medicine and Pharmacy1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2026年1月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
34
试验地点
1
主要终点
Amount of Maxillary Canine Retraction

研究概览

简要总结

This study aims to compare the effects of diode laser and light-emitting diode (LED) photobiomodulation on maxillary canine retraction during fixed orthodontic treatment. Participants requiring bilateral maxillary first premolar extraction will receive both interventions using a split-mouth design. One maxillary canine will receive diode laser photobiomodulation, while the contralateral maxillary canine will receive LED photobiomodulation.

Maxillary canine movement will be evaluated at 4, 8, 12, and 16 weeks during retraction to compare the amount and rate of tooth movement between the two interventions. Pain associated with orthodontic tooth movement will also be assessed.

Pulp oxygen saturation (SpO₂) of the maxillary canines will be measured to evaluate changes in pulpal oxygenation during orthodontic canine retraction. SpO₂ will be assessed at baseline and at predefined follow-up time points, including 20 minutes, 24 hours, 7 days, and 4 weeks. Changes in SpO₂ will be compared between the diode laser and LED sides.

Cone-beam computed tomography (CBCT) will be used to evaluate changes in maxillary canine root length and alveolar bone dimensions before and after canine retraction.

The study is expected to determine whether diode laser and LED photobiomodulation differ in their effects on orthodontic canine retraction, pulpal oxygenation, pain, and associated dental and alveolar bone changes.

详细描述

This is an interventional split-mouth clinical study comparing diode laser and light-emitting diode (LED) photobiomodulation during maxillary canine retraction in patients undergoing fixed orthodontic treatment.

After alignment and leveling, maxillary canine retraction will be performed using standardized orthodontic mechanics. Each participant will receive both photobiomodulation interventions. One maxillary canine will receive diode laser photobiomodulation, while the contralateral maxillary canine will receive LED photobiomodulation according to the predefined side-allocation procedure. The interventions will be repeated at 4-week intervals during the 16-week observation period.

Digital intraoral scans will be obtained to quantify maxillary canine movement. Cumulative canine retraction will be assessed at 4, 8, 12, and 16 weeks. The amount and rate of canine retraction will be compared between the diode laser and LED sides within the same participant.

Pulp oxygen saturation (SpO₂) of the maxillary canines will be assessed to evaluate pulpal oxygenation during orthodontic tooth movement. SpO₂ measurements will be obtained separately from the canine receiving diode laser photobiomodulation and the contralateral canine receiving LED photobiomodulation at baseline, 20 minutes, 24 hours, 7 days, and 4 weeks after initiation of canine retraction. Changes from baseline and differences in SpO₂ between the two intervention sides will be evaluated.

Pain associated with orthodontic tooth movement will be assessed using a visual analog scale (VAS) after photobiomodulation. Cone-beam computed tomography (CBCT) examinations obtained before and after the canine retraction period will be used to evaluate changes in maxillary canine root length and alveolar bone dimensions.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with complete permanent dentition and cervical vertebral maturation at CS5 or CS6 according to the Baccetti classification.
  • Angle Class I malocclusion.
  • Indication for fixed orthodontic treatment requiring bilateral extraction of the maxillary first premolars.
  • Similar position, morphology, and dimensions of the maxillary canines on both sides.
  • No previous orthodontic treatment.
  • Willingness to participate in the study and provision of informed consent.

排除标准

  • Patients with bleeding or coagulation disorders, diabetes mellitus, bone diseases, or periodontal diseases.
  • Use of medications that may affect orthodontic tooth movement or coagulation, including aspirin, heparin, warfarin, nonsteroidal anti-inflammatory drugs, or glucocorticoids.
  • History of maxillofacial trauma or craniofacial anomalies.
  • Pregnancy.
  • Requirement for extraction of teeth other than the first premolars.

研究组 & 干预措施

Diode Laser

Experimental

The maxillary canine allocated to the diode laser side will receive diode laser photobiomodulation during orthodontic canine retraction. Photobiomodulation will be applied according to the study protocol and repeated at 4-week intervals during the 16-week observation period.

干预措施: Diode Laser Photobiomodulation (Device)

LED

Active Comparator

The contralateral maxillary canine allocated to the LED side will receive light-emitting diode (LED) photobiomodulation during orthodontic canine retraction. Photobiomodulation will be applied according to the study protocol and repeated at 4-week intervals during the 16-week observation period.

干预措施: LED Photobiomodulation (Device)

结局指标

主要结局

Amount of Maxillary Canine Retraction

时间窗: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks

The amount of maxillary canine retraction will be measured in millimeters using digital intraoral scans. Canine movement will be assessed by comparing the position of the maxillary canine at baseline and at each follow-up time point. The amount of retraction on the diode laser side will be compared with that on the contralateral LED side within the same participant.

次要结局

  • Pain Intensity Following Orthodontic Canine Retraction(1 day, 3 days, and 7 days after photobiomodulation)
  • Change in Maxillary Canine Root Length(Baseline and 16 weeks)
  • Change in Alveolar Bone Dimensions Around the Maxillary Canine(Baseline and 16 weeks)
  • Change in Pulp Oxygen Saturation of the Maxillary Canine(Baseline, 20 minutes, 24 hours, 7 days, and 4 weeks after initiation of canine retraction.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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