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临床试验/NCT04376164
NCT04376164已完成不适用

Outcome of Low-level Laser Therapy Regarding Orthodontic Leveling and Alignment of Mandibular Anterior Segment: A Controlled Clinical Appraisal

Tharwat osman Mohi Eldeen Elshehawy2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
26
试验地点
2
主要终点
Evaluation of the alignment rate of the mandibular anterior segment with and without low level laser therapy

研究概览

简要总结

to evaluate the outcome of LLLT regarding leveling and alignment of the mandibular anterior segment.

详细描述

Thirty patients, 18 females and 12 males, were included who had Class I malocclusion with moderate mandibular crowding and an average age was 19.23 ± 3.1years.They were randomly divided into two parallel groups; a control group without laser intervention and a laser group which received LLLT. All patients followed a non-extraction approach using one category of fixed appliance and matching conventional NiTi archwire sequence during 3 months observation period. In laser group, mandibular anterior teeth were irradiated by gallium aluminum arsenide semiconductor laser with 635 nm wavelength, 6.5J/cm2energy density, for 10 seconds at 10 points (0.2 J/point) on facial and lingual aspects. This protocol was started immediately after first wire insertion and then at days 3,7,14 of the first month and repeated for additional 2 months. In both groups, relief of mandibular crowding was assessed by Little's irregularity index (LII) after 4 weeks (T1), after 8 weeks (T2), and after 12 weeks (T3) intervals. Changes in LII scores were evaluated through scanned 3D models via software. In addition, the monthly rate of OTM was calculated and compared. The level of significance was set at p ≤ 0.05.

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
None

入排标准

年龄范围
16 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Selection of participants was based on the following criteria:
  • The age range was from 15 to 25 years.
  • All permanent teeth erupted (3rd molar not included).
  • Angle class I occlusion with normal facial proportions.
  • Moderate crowding in the lower dental arch assessed by Little's irregularity index that requires treatment with fixed appliance using non-extraction approach.
  • Good oral and general health.
  • No previous or current periodontal disease.
  • No systemic disease or regular medication that could interfere and\or affects orthodontic teeth movement.
  • No evidence of craniofacial anomalies, such as cleft lip and palate or previous history of trauma, bruxism or parafunction.
  • No previous orthodontic treatment.

排除标准

  • The patients were excluded from the study if they have:
  • Severe crowding that requires an extraction approach.
  • Blocked-out teeth that didn't allow for placement of the bracket at the initial bonding appointment.
  • Poor oral hygiene or periodontally compromised teeth.
  • Relevant medical history that interferes with orthodontic treatment.
  • Craniofacial anomalies or previous history of trauma, bruxism or parafunction.
  • Previous orthodontic treatment.
  • The deep bite which interferes with orthodontic brackets placement.

结局指标

主要结局

Evaluation of the alignment rate of the mandibular anterior segment with and without low level laser therapy

时间窗: 6 Months

Effect of the LLLT on alignment of the mandibular anterior teeth through evaluation of changes in Little's Irregularity Index (LII) scores (mm) throughout 12 weeks observation period of the study

次要结局

未报告次要终点

研究者

发起方
Tharwat osman Mohi Eldeen Elshehawy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tharwat osman Mohi Eldeen Elshehawy

Dentist, Ministry of Health, MSc student, Department of Orthodontics, Faculty of Dental Medicine (Boys), Al-Azhar University, Cairo, Egypt.

Al-Azhar University

研究点 (2)

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