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临床试验/CTRI/2024/10/075423
CTRI/2024/10/075423尚未招募Phase 3 4

THE EFFECTIVENESS OF SOFT AND HARD SPLINTS IN THE SYMPTOMATIC MANAGEMENT OF TEMPOROMANDIBULAR JOINT DISORDERS: A COMPARATIVE STUDY

Dr Bharti Vyas1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月1日最近更新:
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试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
a) Pain
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Study aims at comparative evaluation of effectiveness of hard and soft occlusal splint for the symptomatic relief of temporomandibular joint disorders.

The comparison is drawn between the hard and soft splint effects in terms of relief in pain, mouth opening, muscle tenderness and clicking after wearing the occlusal splint for minimum of 22 hours for duration of 4 months with measurement of data every 1 month following the delivery of the appliance.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
16.00 Year(s) 至 60.00 Year(s)（—）
性别
All

入选标准

  • •Diagnosis of Myofascial pain ( Tenderness of masticatory muscles, deviated or restricted mandibular movement and myofascial pain duration of atleast 3 months) and Internal derangement of Temporomandibular joint with Reciprocal clicking ( Anterior disc displacement with reduction, negative locked jaw, history of TMJ noise).

排除标准

  • •1.Previous history of treatment for TMD.
  • •2.Patient diagnosed with osteoarthrtis or osteoarthrosis of TMJ.
  • •3.Patients with previous history of treatment for TMDs. 4.Patient diagnosed with disc displacement without reduction.
  • •5.Patient diagnosed with any other causes of Trismus.

结局指标

主要结局

a) Pain

时间窗: 4 months

b) Maximum mouth opening

时间窗: 4 months

c) TMJ clicking

时间窗: 4 months

d) Muscle tenderness

时间窗: 4 months

次要结局

  • Maximum mouth opening(TMJ clicking)

研究者

发起方
Dr Bharti Vyas
申办方类型
Other [individual]
责任方
Principal Investigator
主要研究者

Dr Bharti Vyas

Government College of Dentistry, Indore

研究点 (1)

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