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临床试验/CTRI/2019/11/021981
CTRI/2019/11/021981进行中(未招募)4 期

Comparative Evaluation of Efficacy of Low Level Diode Laser Therapy and Conventional Medical Therapy in Recovery of Infraorbital or Inferior Alveolar Neurosensory Deficits in Participants Undergoing Open Reduction and Internal Fixation for Maxillofacial Trauma - A Prospective Randomized Observer Blind Study.

MGM Dental College and Hospital Navi Mumbai1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年11月15日最近更新:

试验速览

阶段
4 期
状态
进行中(未招募)
发起方
入组人数
40
试验地点
1
主要终点
Compare the effectiveness of low level diode laser therapy(LLLT) and conventional medical therapy using two point discrimination , pin prick stimuli and thermal discrimination conducted on various intervals upto 6 months for recovery of infraorbital or inferior alveolar neurosensory deficits.

研究概览

简要总结

This is a randomized , observer blind study in which two groups of patients are recruited depending upon the treatment modality the patient is going to be subjected to be. Followed by that clinical nerve sensory testing will be performed at various intervals and outcomes will be recorded.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant and Outcome Assessor Blinded

入排标准

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

入选标准

  • Participants of both the genders between age group of 18-60 years.
  • Participants with post traumatic neurosensory disturbances of infraorbital or inferior alveolar nerves in unilateral facial fractures requiring open reduction and internal fixation.
  • Participants willing for the study and follow up.

排除标准

  • Isolated zygomatic arch and condylar process fractures.
  • Participants with neurologic disorder like seizures.
  • Participants with systemic diseases such as diabetes, Thyroid disorders, carcinomas, on steroids etc.
  • Pregnant females.
  • Participants with a history of head injury, Uncooperative and mentally retarded participants.

结局指标

主要结局

Compare the effectiveness of low level diode laser therapy(LLLT) and conventional medical therapy using two point discrimination , pin prick stimuli and thermal discrimination conducted on various intervals upto 6 months for recovery of infraorbital or inferior alveolar neurosensory deficits.

时间窗: 24 hours prior to surgery, 48hrs after surgery, 7th day, after 1 month, 3 months and 6 months.

次要结局

  • 1) Degree of neurosensory deficit of infraorbital and inferior alveolar nerve.(2) Progress of recovery of neurosensory deficit of infraorbital and inferior alveolar nerve.)

研究者

发起方
MGM Dental College and Hospital Navi Mumbai
申办方类型
Private medical college

研究点 (1)

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