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临床试验/NCT02960048
NCT02960048Unknown不适用

Clinical Evaluation of Stabilizing Splint (Michigan-type Occlusal Splint) Versus Anterior Repositioning Splint in Patients With Temporomandibular Joint Anterior Disc Displacement With Reduction . ( Randomized Controlled Clinical Study)

Cairo University0 个研究点目标入组 60 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
主要终点
Patients' subjective pain experience.

研究概览

简要总结

To evaluate the effectiveness of Michigan-type occlusal splint and anterior repositioning splint in patients with temporomandibular joint anterior disc displacement with reduction.

详细描述

To evaluate the effectiveness of Michigan-type occlusal splint and anterior repositioning splint in patients with temporomandibular joint anterior disc displacement with reduction.

PICO:

Population (P): Patients with symptomatic anterior disc displacement with reduction.

Intervention (I): Michigan splint. Comparator (C): Anterior repositioning splint (ARS) .

Outcome(O):

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

性别
All
接受健康志愿者

入选标准

  • Adult patient from 15 to 50 years old.
  • Report of pain in preauricular region worsened by functional activities, such as chewing and talking.
  • Presence of disc displacement with reduction and joint clicking
  • positive diagnosis of unilateral or bilateral anterior disc displacement with reduction by means of magnetic resonance imaging (MRI).

排除标准

  • History of TMJ surgery.
  • Individuals with osteoarthritis.
  • Individuals under TMD management.
  • Individuals wearing full or partial dentures.
  • Individuals with major psychological disorders.
  • Nonreducing dislocations of the articular disc
  • Consequences of condyle fractures and/or fracture of another maxillofacial zone.
  • Articular pathologies of systemic nature (e.g., rheumatoid arthritis, arthrosis, psoriasis arthritis).
  • Individuals with a recent history of trauma in the face and/or neck area. Individuals with systemic diseases that can affect TMJ

结局指标

主要结局

Patients' subjective pain experience.

时间窗: 3 months

Each patient will be asked to rate his or her current and worst pain intensity on numerical rating scale (NRS) of 0-10 with zero being no pain and ten corresponds to the worst pain that the patient ever had.

次要结局

  • Maximum mouth opening.(3 months)
  • Lateral excursion.(3 months)
  • Protrusion.(3 months)

研究者

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

Moataz Nasr

Oral and maxillofacial surgery resident in Sahel Teaching hospital

Cairo University

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