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临床试验/NCT04376190
NCT04376190已完成不适用

Three-dimensional Judgment of Mandibular Condylar Volume and Position Subsequent to Twin-block Functional Therapy of Skeletal Class II Malocclusion Accompanied With Low-level Laser Therapy

mahmoud abdelhameed mohamed2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2017年12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
24
试验地点
2
主要终点
Changes of condylar volume (mm3) and condylar head position before and after Twin-block therapy with and without LLLT:

研究概览

简要总结

to evaluate effect of low-level laser therapy (LLLT) on mandibular condylar volume and position after treatment of Class II malocclusion with Twin Block (TB) functional therapy via cone beam computed tomography (CBCT).

Materials and methods: Twenty eight growing patients, 14 boys and 14 girls ranged in age 9-12 years, were randomly divided into control group (mean initial age 10.64±1.36 years) and laser group (mean initial age 10.55 1.45 years). All patients treated with TB appliance where Gallium aluminum arsenide diode laser applied in one group weekly around TMJ region for 12 sessions in three months with set parameters: continuous 635 nm, 50 mW, 4.5J/cm2, 45 seconds/ point, total dose per side 11.25J. CBCT were obtained before and immediately after TB therapy, in addition to routine orthodontic records. Changes in TMJ and skeletal variables were analyzed and compared within and between both groups.

详细描述

to evaluate the effect of low-level laser therapy (LLLT) on mandibular condylar volume and position after treatment of Class II malocclusion with Twin Block (TB) functional therapy via cone-beam computed tomography (CBCT).

Materials and methods

Twenty-eight growing patients, 14 boys, and 14 girls ranged in age 9-12 years, were randomly divided into control group (mean initial age 10.64±1.36 years), and laser group (mean initial age 10.55 1.45 years). All patients treated with TB appliance where Gallium aluminum arsenide diode laser applied in one group weekly around TMJ region for 12 sessions in three months with set parameters: continuous 635 nm, 50 mW, 4.5J/cm2, 45 seconds/ point, total dose per side 11.25J. CBCT were obtained before and immediately after TB therapy, in addition to routine orthodontic records. Changes in TMJ and skeletal variables were analyzed and compared within and between both groups.

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
9 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Skeletal Class II (ANB°> 5°) with the normal maxilla (SNA°=82°±4°) and retrognathic mandible (SNB°< 78°).
  • Overjet greater than 5 mm.
  • Minimal crowding in dental arches (≤ 3 mm).
  • The lower incisors should be on average inclination or slightly retroclined.
  • All the patients were in stages II and III based on the modified cervical vertebral maturation stages(CVMS) according to Bacetti et al.

排除标准

  • Previous history of orthodontic treatment.
  • Congenitally missing or extracted permanent tooth (except third molars).
  • Posterior crossbites or severe maxillary transverse deficiency.
  • Severe facial asymmetry determined by clinical or radiographic examination.
  • Poor oral hygiene.
  • Systemic diseases that may affect orthodontic treatment results.

结局指标

主要结局

Changes of condylar volume (mm3) and condylar head position before and after Twin-block therapy with and without LLLT:

时间窗: after 9 mouth from starting treatment

3D condylar volume measured using software and 2D condylar head position

次要结局

  • Changes of cephalometric skeletal measurements before and after Twin-block therapy with and without LLLT(after 9 mouth from starting treatment)

研究者

发起方
mahmoud abdelhameed mohamed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

mahmoud abdelhameed mohamed

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

Al-Azhar University

研究点 (2)

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