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临床试验/NCT05962619
NCT05962619尚未招募不适用

Arthrocentesis Alone Versus Arthrocentesis With Hyaluronic Acid Injection in Management of Temporomandibular Joint Dysfunction in the Form of Anterior Disc Displacement With Reduction : a Randomized Controlled Trial

Assiut University0 个研究点目标入组 42 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
42
主要终点
Tempero mandibular joint pain

研究概览

简要总结

Comparison between Arthrocentesis alone arthrocentesis with hyaluronic acid injection in management of temporomandibular joint dysfunction in the form of anterior disc displacement with reduction.

详细描述

Temporomandibular joint (TMJ) anterior disc displacement (ADD) is one of the most common TMJ disorders.It can occur in all age groups, with a high prevalence in adolescents .

ADD often presents with clicking, joint pain, a limited range of mouth opening. Furthermore,ADD might lead to osteoarthrosis .

Since ADD of the TMJ can lead to various harmful outcomes, how to manage ADD is considered a key problem for most TMJ experts. It has been difficult for most clinicians to select a suitable method for ADD patients with different grades of severitis ). Initially, these conditions can be managed conservatively by employing techniques such as occlusal splint therapy, physiotherapy, pharmacotherapy and occlusal treatments. If Medical treatment fails, minimally invasive (sodium hyaluronate or corticosteroid infiltrations and arthrocentesis) and invasive treatments (arthroscopy, arthroplasty, arthrotomy, discectomy, condylotomy) are formed ). Sodium hyaluronate is a buffered solution of hyaluronate acid sodium salt, which is an essential component of the cartilage.It acts against the disintegration of the extracellular matrix.It reduces friction, and it features an anti-inflamatory effect. It is indicated for the treatment of osteoarthritic symptoms and inflammatory degenerative joint disease). Intra-articular hyaluronic acid injection provides long-term palliative effects on symptoms and signs of TMJ pain .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • Adults with age between( 18-45) years
  • Both genders
  • The cases ciinically have either of ( limitation of mouth opening , pre-auricular pain , headache, temporal, and occipital tenderness ) and radiologically (MRI) diagnosed as ADD with reduction
  • The patients have symptom durations for more than 3 months with medical treatment.
  • Patients whom did not respond to medical treatment

排除标准

  • Previous TMJ surgery or previous arthrocentesis.
  • Patients with arthritis or history of condylar trauma
  • Patients with degenerative change of the condylar head and with facial asymmetry, retrognathism, or prognathism
  • Severe co-morbid conditions (uncontrolled diabetes, Hypertenion

结局指标

主要结局

Tempero mandibular joint pain

时间窗: One month

Pain was assessed using visual analogue scale (VAS): which ranges from zero to 10 (where zero refers to no pain, 1:3 mild pain, 4:6 moderate pain, 7:9 severe pain and 10 maximum pain) assessing pre and post operative will provide good evidence about effect of arthrocentesis in decrease Tempero mandibular joint pain

Mouth opening

时间窗: Three months

Maximum inter-incisal opening (MIO): measured by Vernier caliper in millimeters (mm) as the vertical distance between the incisal edges of maxillary and mandibular central incisors. Preoperative and postoperative measurement of MIO would help in evaluation of improvement in mouth opening after arthrocentesis

次要结局

  • Clicking(Three months)

研究者

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

Ahmed Mohammed Hussein Ali

Principle investigator

Assiut University

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