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临床试验/CTRI/2020/07/026716
CTRI/2020/07/026716尚未招募1 期

‘Comparative Evaluation of Temporomandibular joint Function And Treatment Response Using Joint Vibration Analysis In Patients Exhibiting Disc Displacement With Reduction, Treated With Three Variable Thickness Of Stabilization Splints : An In- Vivo Study

未提供1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年7月25日最近更新:
适应症

试验速览

阶段
1 期
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Effect of different thickness of stabilization splint (3mm,4mm,5mm)on Temporomandibular joint.

研究概览

简要总结

Temporomandibular   joint disorders (TMD) is a cluster of coexisting conditions and clinical problems with multifactorial etiology with many factors contributing to the progression and management of the disease. The use of splints is presently considered the most common treatment modality.

The study will be conducted to investigate the effect of variable thicknesses of stabilization splint on the Temporomandibular  joint in patients with disc displacement with reduction using joint vibration analysis as a diagnostic tool.

 A total of 30 subjects with the age range of 18-55 years including both male and female visiting the Department of Prosthodontics at VSPM Dental College and Research Centre Nagpur will be recruited.

 The study population will be divided into 3 groups:

  1. Group A – 10 patients, both males and females  given stabilization splint of thickness 3 mm

  2. Group B – 10 patients, both males and females given stabilization splint of thickness 4mm

  3. Group C – 10 patients, both males and females  given stabilization splint of thickness 5mm

 Written informed consent will be taken from the patients prior.

Though there have been reported studies of comparison between different types of splints, comparative evaluation of the treatment response using the varying thickness of splints using JVA has not been done before which brings the need for the study to be conducted.

The result will be obtained by the improvement seen in temporomandibular joint disorder.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • •1.Patient with Disc displacement with reduction.
  • •2.Clicking or pain present.
  • •3.Reduced and/or deviated mouth opening and any other symptoms using RDC-TMD criteria.12 4.Patients were willing to be a part of the study.

排除标准

  • •1.Asymptomatic patients.
  • •2.Patient with Disc displacement without reduction.
  • •3.Medically compromised patients.
  • •4.Patients not willing to take part in the study.

结局指标

主要结局

Effect of different thickness of stabilization splint (3mm,4mm,5mm)on Temporomandibular joint.

时间窗: Effect of different thickness of stabilization splints at interval of 3 weeks,5 weeks and 7 weeks.

次要结局

  • Variation In Joint Vibration Analysis(Preoprative -0Weeks)

研究者

发起方
未提供

研究点 (1)

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