CTRI/2021/01/030845尚未招募不适用
Comparative Evaluation of Efficacy of CAD-CAM Assisted Patient Specific Polyetheretherketone (Peek) Plate with 3D Delta Titanium Plate for the Fixation of Mandibular Subcondylar Fractures - A Prospective Randomized Controlled Trial
Datta Meghe Institute of Medical Sciences Deemed to be University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年1月2日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The CAD-CAM assisted customized PEEK plate may be more effective in achieving the goals of fixation of mandibular subcondylar fractures as compared to the 3D Delta Titanium plates
研究概览
简要总结
Thecurrent study isdesigned to generate the evidence for the use of CAD-CAM assisted customizedPEEK plate for accurate reduction and fixation of mandibular subcondylarfractures with minimal post-operative complications as compared to conventional3D Delta Titanium plates
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Cases of unilateral mandibular subcondylar fractures (mostly associated with symphysis / parasymphysis fracture).
- •Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
- •Systemically healthy patients with ASA I/II grades.
- •Patients with good general condition allowing major surgical procedure under general anaesthesia.
排除标准
- •Patients with trifocal fractures in mandible will be excluded from the study.
- •Patients with old fractures as they might affect accuracy of reduction of the fractured segments.
- •Patient with comminuted fracture in condylar region Patients with bone loss or soft tissue loss at fracture site Endocrinopathies affecting calcium metabolism, chronic smokers, post menopausal women.
- •Patients with mixed dentition and edentulous lower arch Evidence of infections at fracture site (diagnosed clinically, not with culture) Epileptic patients Medically compromised patients not fit for surgery.
- •Patient not willing for surgical treatment.
结局指标
主要结局
The CAD-CAM assisted customized PEEK plate may be more effective in achieving the goals of fixation of mandibular subcondylar fractures as compared to the 3D Delta Titanium plates
时间窗: Postoperatively 1st Week, 4th week and 12th week
次要结局
- The CAD-CAM assisted customised PEEK plate may be more effective in achieving the goals of fixation of mandibular subcondylar fractures as compared to the 3D Delta Titanium plates.(Postoperatively 1st week, 4th week and 12th week)
研究者
研究点 (1)
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