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临床试验/CTRI/2019/09/021118
CTRI/2019/09/021118招募中不适用

Comparison of Intraoral vertical ramus osteotomy and High condylectomy with disc repositioning in the management of non-reducing disc displacement of TMJ – A randomised control trial

Armed Forces Medical Research Committee1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年1月4日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
Clinical Parameters

研究概览

简要总结

30 subjectsfulfilling the inclusion and exclusion criteria will be randomly allocated into02 groups after informed consent. Pre-operative MRI and clinical parameterswill be recorded for all patients. The patients will be randomly allocated to02 groups. Group A will be managed by Intraoral Vertical ramus osteotomyfollowed by Maxillomandibular fixation for 02 weeks and Group B will be managedby high condylectomy with disc repositioning by partial/full thickness excisionwith/without lateral tuberclectomy according to existing contemporary surgicalprotocols. The clinical parameters will be recorded at 03, 06 and 12 months post-operatively. Post-operative MRI will betaken at 12 months post-surgery and assessed. The results will be analysedusing appropriate statistical tests to establish the efficacy of both theprocedures and to establish a comparison between the two procedures

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 1.Clinical diagnosis of Non-reducing disc displacement 2.MRI evidence of Non-reducing disc displacement 3.Unsuccessful non-surgical treatment for atleast 06 months 4.Willing for a follow up of 02 years.

排除标准

  • 1.Previous H/o TMJ surgery or orthognathic surgery 2.Dentofacial deformities 3.Other TMJ arthritides/ pathology.

结局指标

主要结局

Clinical Parameters

时间窗: 0, 3, 6, 12 months

1 Pain

时间窗: 0, 3, 6, 12 months

2 Mandibular function impairment questionnaire

时间窗: 0, 3, 6, 12 months

3 Maximal Interincisal opening

时间窗: 0, 3, 6, 12 months

7 Deviation on mouth opening

时间窗: 0, 3, 6, 12 months

4 Maximal Protrusion

时间窗: 0, 3, 6, 12 months

5 Maximal Laterotrusion to affected side

时间窗: 0, 3, 6, 12 months

6 Maximal Laterotrusion to unaffected side

时间窗: 0, 3, 6, 12 months

8 Clicking of the affected joint

时间窗: 0, 3, 6, 12 months

9 Crepitus of the affected joint

时间窗: 0, 3, 6, 12 months

10 Occlusal disturbances

时间窗: 0, 3, 6, 12 months

11 Tenderness of TMJ

时间窗: 0, 3, 6, 12 months

12 Tenderness of muscles of mastication

时间窗: 0, 3, 6, 12 months

次要结局

  • Radiological Parameters:(13.Position of interarticular disc at closed mouth position)
  • Post-operative Morbidity Parameters:(19.Temporary Facial Nerve Paresis)
  • Resource Parameters with special reference to the Armed Forces:(25.Time taken for unrestricted function)

研究者

发起方
Armed Forces Medical Research Committee
申办方类型
Government funding agency

研究点 (1)

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