A COMPARATIVE EVALUATION OF CLOSED AND OPEN (TRANSPAROTID) TREATMENT IN THE MANAGEMENT OF UNILATERAL CONDYLAR NECK OR SUBCONDYLAR FRACTURES WITH OR WITHOUT PARASYMPHYSIS FRACTURE: RANDOMIZED CLINICAL STUDY.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The present study will evaluate and compare the management of condylar fracture with ORIF through transparotid approach and CRMMF.
研究概览
简要总结
To evaluate and compare closed and open (transparotid) treatment in the management of unilateral condylar neck or subcondylar fractures with or without parasymphysis fracture. Two groups of 12 Patients each requiring treatment condylar fracture and those who are willing to participate and have agreed to postoperative follow-up will be included in the study.Study population include 24 patients with unilateral condylar fracture. The study design involves treating the group A patient with arch bar and intermaxillary fixation alone for 4 weeks and group 2 patient with implant plates surgically. Follow up of 1st, 3rd and 6th month. Key parameters includes maximal mouth opening, pain while mouth opening & anatomical ramus height shortening. By comparing the outcomes between the two groups, the study aims to provide treatment with less pain, discomfort and less facial asymmetry. The study result will be helpful in clinical application of condylar fractures management and can also be used for further researc
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient aged more than 18 years.
- •Patient with unilateral condylar fracture with or without parasymphysis fracture.
- •In the posteroanterior aspect of the mandible, the degree of deviation between the condylar fragment and the ascending ramus is between 10° and 45°, either laterally or medially, with a vertical ramus height shortening of 2–15 mm.
- •The patient must have a good complement of teeth especially posterior teeth.
- •Patient should give consent to participate in the study.
排除标准
- •Previous history of temporomandibular joint dysfunction.
- •Severe pretraumatic dysgnathia.
- •Patient with condylar head fracture.
- •Insufficient dentition to reproduce normal occlusion.
- •All medically compromised patients.
- •Associated midface fractures.
- •Pregnant women.
结局指标
主要结局
The present study will evaluate and compare the management of condylar fracture with ORIF through transparotid approach and CRMMF.
时间窗: 6 MONTHS
This study will help in identifying treatment with less pain, discomfort and less facial asymmetry
时间窗: 6 MONTHS
次要结局
-  The study result will be helpful in clinical application of condylar fractures management and can also be used for further research(6 MONTHS)
研究者
Shivam Shukla
Government Dental college Raipur