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临床试验/NCT05362877
NCT05362877已完成不适用

The Effect of Earplugs on Myogenous Temporomandibular Disorders

Istanbul University2 个研究点 分布在 2 个国家目标入组 120 人开始时间: 2023年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
Values of maximal mouth opening(millimeter)

研究概览

简要总结

The term temporomandibular joint disorder (TMD) refers to a group of disorders affecting the temporomandibular joint and/or muscles of mastication. Typical symptoms are; joint noises, pain, and limited mouth opening. Many therapeutic modalities have been advocated for the treatment of TMD as intraoral splints, laser, ultrasound, physical therapy, surgery, and medications with inconsistent reported results due to the multifactorial etiology of this disorder. Although intraoral splints are the most widely used therapy, it has some drawbacks as being inconvenient for the patient due to their relatively large size interferes with eating and affects speech, therefore their use is mostly limited to sleeping time, which decreases its effectiveness.

Recently some commercial earplugs that claim to treat TMD have been introduced, however, there is no validated data regarding these appliances. Thus, this study aimss to evaluate the possible effect of earplugs on myogenous TMD.

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 (Care Provider)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pain in masticatory muscles for at least 3 months according to the DC/TMD
  • Having a stable medication regimen for at least 1 month
  • Age of 18-65 years
  • Minimum pain intensity of 50 mm on a 100 mm visual analog scale (VAS)
  • No concomitant systemic disease
  • Natural posterior occlusion.

排除标准

  • Undergoing physical therapy
  • Using muscle relaxants and/or NSAIDs
  • Previous TMD treatment more recently than one year
  • Major psychosocial problems
  • Undergoing orthodontic treatment
  • Wearing removable prosthesis
  • Pregnancy
  • History of facial trauma.

结局指标

主要结局

Values of maximal mouth opening(millimeter)

时间窗: 2 months

Evaluating mouth opening by using digital caliper

次要结局

  • Pain perception(2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Merve Benli

Assistant professor

Istanbul University

研究点 (2)

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