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临床试验/NCT04468464
NCT04468464Unknown不适用

Quantitative Evaluation of Osteopathic Treatment in Temporomandibular Joint Disorders Using Magnetic Resonance Imaging

Yeditepe University2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2018年9月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
19
试验地点
2
主要终点
Change in Mandibular Movements

研究概览

简要总结

The aim of this study is to assess the impact of osteopathic manual treatment in patients with an anterior disc displacement over sleep and health quality, pain scores and the movement of the condyle and disc of the temporomandibular joint (TMJ) quantitatively.

详细描述

Patients with TMD will involve to this study. After having the diagnose in Yeditepe U. Dental Hospital patients will be sent to the Radiology Department. MRI images will be gathered in sagittal, coronal and axial plane for each patient before and after treatment. Volunteers will be divided into two groups; (1) splint therapy for 6 weeks, (2) splint therapy + osteopathy 2 times a week for 6 weeks randomly. At the end of the treatment, patients will be sent to Radiology for the second images. Health Survey and pain scores, Disc condyle angle, disc and condyle displacements will be measured and compared inter and intra 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
Double (Investigator, Outcomes Assessor)

盲法说明

The Radiologist who evaluates the MRI results was blinded about the group of participants and also blinded about the diagnosis of the dentist.

入排标准

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

入选标准

  • Clinical diagnosis of TMD (anterior disc displacement)

排除标准

  • Active orthodontic treatment
  • Systemic diseases
  • Oral or dental pathologies
  • Dental implant placement
  • Exodontia within 6 months
  • Cranial and cervical trauma or surgery
  • Taking antidepressant medication
  • Contraindication of MRI scans

结局指标

主要结局

Change in Mandibular Movements

时间窗: 6 weeks after the first measurement

Depression, Left and Right lateralization of the mandibula was measured by the caliper

Change in Cervical Movement

时间窗: 6 weeks after the first measurement

Cervical Region range of motions was measured by a goniometer

Change in TMJ MR images

时间窗: 6 weeks after the first measurement

Disc-condyle angle, disc and condyle positions were measured over TMJ images

Change in Temporomandibular Joint Pain

时间窗: 6 weeks after the first measurement

10 point scale 0- no pain 10- severe pain

次要结局

  • Changes in bodily pain(6 weeks after the first measurement)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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