the evaluation of trinity plate in the reduction and fixation of symphysis and parasymphysis fractures of mandible: a prospective clinical study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- OCCLUSAL DISCREPANCY
研究概览
简要总结
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Mandibular fractures represent the second most common facial fractures, preceded by nasal bone fractures. Symphysis/ parasymphysis fractures comprise15.6 to 29.3%of mandibular fractures.
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Various treatment modalities in managementof maxillofacial trauma range from conservative procedureslike maxillo-mandibular fixation,splints to surgical options such as circum-mandibular wiring and semi-rigid fixationwith trans-osseous wiring to rigid fixationwith compression platesand recently semi-rigid fixation with mini plates.
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Fixationby conventional stainless steelmini plate carrieshigh morbidity and infection rates.Whereas theprobablelimitationof 3D platesmay be excessive implantmaterial.
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Hence the new design of mini plate has been developed in an attempt to overcome limitations of previous fixation techniques and to acquire better retention as well as stability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •NON COMMINUTED NON INFECTED MANDIBULAR SYMPHYSIS AND PARA SYMPHYSIS FRACTURE WITH ANY OTHER CONCOMITANT FRACTURE SINGLE NON COMMINUTED FRACTURE OF THE MANDIBULAR SYMPHYSIS AND / OR PARASYMPHYSIS REQUIRING OPEN REDUCTION AND INTERNAL FIXATION.
排除标准
- •PATIENT NOT FIT FOR GENERAL ANESTHESIA OR LOCAL ANESTHESIA PATIENT WITH SYSTAMIC DISEASES PATIENT WITH ASSOCIATED MANDIBUALR BONE PATHOLOGY PATIENT WHO DONT GIVE CONSENT FOR THE STUDY.
结局指标
主要结局
OCCLUSAL DISCREPANCY
时间窗: 1week, 1month, 3months, 6months
POST OPERATIVE MOUTH OPENING
时间窗: 1week, 1month, 3months, 6months
POST OPERATIVE COMPLICATIONS
时间窗: 1week, 1month, 3months, 6months
STABILITY OF PLATE
时间窗: 1week, 1month, 3months, 6months
次要结局
- INTERFRAGMENTARY GAP(INFERIOR BORDER CONTINUITY)