THE EFFICACY OF RESORBABLE PLATES VERSUS TITANIUM PLATES IN TERMS OF STABILITY AMONG PATIENTS WITH MANDIBULAR FRACTURES: A RANDOMIZED CONTROLLED TRIAL.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- bone union
研究概览
简要总结
Objective To compare the efficacy of resorbable plates against titanium plates to determine the fixation stability in reducing mandibular fractures
Method:
Subjects will be recruited and divided into two groups by random allocation. Consents will be obtained and fracture sites will be examined clinically and radiographically. Control group will receive titanium plates and test group will receive resorbable plates. The patients will be recalled immediately at first postop day then at the end of the first month , second month and the third month.They will be evaluated for the reduction of the fractures.
详细描述
Study design:
randomized controlled trial
Study Setting:
The study will be carried out at the Department Of Oral and maxillofacial Surgery in Dow University of Health Sciences and Civil Hospital Karachi
Study Population:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Age group-18 years and above
- •Symphysis and body fractures.
- •Non-infected fracture site
排除标准
- •• Condylar fracture
- •Comminuted fractures
- •Patients with systemic bone diseases
- •Gunshot wounds
- •Pan-facial trauma
- •Infected wounds
研究组 & 干预措施
resorbable plates, test group
after a surgical procedure under general anesthesia , resorbable plates will be placed on the fracture site of the mandibule in 20 patients out of 40 total sample size and will be compared with the titanium plates in the control group
干预措施: surgically mandible will be exposed to reduced the fracture anatomically and then fixated with either resorbable or the titanium plates (Procedure)
titatnium plates, control group
after a surgical procedure under general anesthesia , titanium plates will be placed on the fracturte site in the mandible in 20 patients out of 40 total sample size and will be compared to the test group containing resorbable plates
干预措施: surgically mandible will be exposed to reduced the fracture anatomically and then fixated with either resorbable or the titanium plates (Procedure)
结局指标
主要结局
bone union
时间窗: 3 months
union of the fractured bone will be observed radiographically at the end of the first ,second and the third month by a cone beam computed tomography.
次要结局
未报告次要终点