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临床试验/NCT07730320
NCT07730320已完成不适用

OUTCOME OF PIEZOSURGERY IN LEFORT I OSTEOTOMY OF MAXILLARY OLD MALUNITED FRACTURES VERSUS CONVENTIONAL METHOD: A Randomized Clinical Study

Allama Iqbal Medical College1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
INTROPERATIVE BLOOD LOSS

研究概览

简要总结

To compare the outcomes of piezosurgery and conventional osteotomy in Le Fort I osteotomy for old malunited maxillary fractures in terms of mean duration of surgery and intraoperative blood loss.

详细描述

The development of Piezosurgery was fueled by the need for greater precision and safety in bone surgery than when the standard bur and saw are used. Ultrasonic vibrations have been used to cut tissue for two decades .However, it is only in the last 18 years that it has been used routinely for standard clinical applications in many different fields of surgery. Piezosurgery decreases the risk of damage to the surrounding soft tissues and critical structures (nerves, vessels, and mucosa), particularly during an osteotomy.

Although, in theory, execution of the osteotomy itself is faster if made with the reciprocating saw, the total surgical time is actually shorter when a piezoelectric device is used because less maneuvers to protect the soft tissues are required and a clearer surgical field and increased visibility is produced.

Microvibrations of 60 to 200 m/s at 24 to 29 kHz are applied to cut in mineralized tissue while soft tissue remains unharmed.The literature reports the following possible causes of post bilateral sagittal split osteotomy facial nerve injury direct trauma to the nerve by the osteotomy, direct trauma to the nerve when the mandibular ramus is moved posterior, and postoperative hematoma at the operation site causing pressure necrosis of the nerve.

The objective of the present study was to compare the outcome of Piezosurgery in Lefort I osteotomy of patients having old Malunited Lefort I maxillary fracture as compared to the conventional method in terms of mean operative time and intraoperative blood loss. In this regard, the present survey was conducted from the patients of Department of Oral and Maxillofacial Surgery, Allama Iqbal Medical College, Lahore. Therefore, 60 patients were included by using non-probability consecutive sampling who were undergoing dental treatment after fulfilling the inclusion criteria.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
15 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Malunited Lefort I Fracture of Maxilla for more than three weeks old
  • Untreated Maxillary Fractures.
  • Lefort I fracture on CT SCAN FACE with 3D reconstruction
  • Individuals with ASA1 and ASA2

排除标准

  • Previous Maxillofacial Treatment
  • Lactating mothers and Pregnant Females
  • Any Bone pathology or bone disease determined on Xray

结局指标

主要结局

INTROPERATIVE BLOOD LOSS

时间窗: DURING SURGERY from the start of osteotomy

It was measured in millilitres of increase in irrigation fluid collected during surgery and subtracting the amount of irrigation fluid from the total volume of blood and fluid in the suction bottle. it was classified as low 300 cc medium 400cc high 500cc or more

Mean Duration of Surgery

时间窗: During surgery from the start of maxillary vestibular incision till maxilla is disimpacted post bone osteotomy

It was measured in minutes from the start of maxillary vestibular incision till the disimpaction of maxilla post bone osteotomy during surgery

次要结局

未报告次要终点

研究者

发起方
Allama Iqbal Medical College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maham Azam

Postgraduate Trainee, Oral and Maxillofacial Surgery

Allama Iqbal Medical College

研究点 (1)

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