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
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)
