跳至主要内容
临床试验/NCT06839430
NCT06839430尚未招募不适用

Therapeutic Effect of Using Injectable Hypertonic Saline 5% Versus Injectable Dextrose 20% on Pain in Painful Cases of Disc Displacement with Reduction ( a Randomized Clinical Trial)

Cairo University0 个研究点目标入组 20 人开始时间: 2025年8月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
主要终点
Severity of pain

研究概览

简要总结

This study is aiming to assess effect of hypertonic saline 5% in comparison to dextrose 20% on pain ,inter-insical opening and movements of jaw in painful cases of disc displacement with reduction

详细描述

Intra-articular disorders of the TMJ have been defined as an abnormal positional relationship between the disc and the condyle, articular eminence, and/or articular fossa.

The term internal derangement of the temporomandibular joint (TMJ) indicates an abnormal relationship between the disc, the condyle, and the articular eminence that constrains proper joint function

The disc displacement could be with or without reduction. In disc displacement with reduction, the disc is displaced anterior to the condylar head and remains in this position as long as the mouth is closed. Upon mouth opening, the disc regains its position on the condylar head. The movement of the disc onto and off the condylar head may lead to a clicking sound .

The precise source of internal derangements is not clear; however, it is a complex disorder likely caused by a combination of micro- or macro-trauma, parafunctional behavior, laxity of the joint's soft tissues, and alterations in the synovial fluid's composition

The aims of the internal derangement treatment include alleviating pain, reducing or eliminating joint noises, increasing the degree of mouth opening, and consequently restoring normal TMJ function.

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
15 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •presence of one or more of the following observations in one or both temporomandibular joints:
  • •audible clicking.
  • •mandibular deviation on opening.
  • •Failure of conservative treatment

排除标准

  • •The clinical or radiographic signs of disc displacement without reduction, osteoarthritis, or articular bony changes.
  • •Previous TMJ surgery, arthrocentesis, , or the presence of any systemic disease that would affect the TMJ anatomy or mechanical function.
  • •A history of allergic reactions to any components of the injectable solution.
  • •Infection of the affected joint and pre-auricular area.
  • •Previous surgery of the affected joint

研究组 & 干预措施

painful cases with disc displacement with reduction

Active Comparator

painful cases of disc displacement with reduction

Experimental

干预措施: hypertonic saline 5% sodium chloride (Other)

结局指标

主要结局

Severity of pain

时间窗: baseline and at 6 months

severity of pain is measured by Visual analog scale (VAS) From (0-10) Where 0: no pain 10: worst pain

次要结局

未报告次要终点

研究者

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

Aya Allah Gamal Salah

Aya Allah Gamal

Cairo University

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