Prognostic evaluation of infraorbital nerve injury in isolated unilateral zygomaticomaxillary complex fractures: A comprehensive preoperative and postoperative assessment of neurosensory function and quality of life.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Neurosensory assessment of infraorbital nerve injury in surgical patients using Pin prick test, cold thermal test, two-point discrimination test, light touch monofilament test, quality of life assessment.
研究概览
简要总结
Prognostic evaluation of infraorbital nerve injury in isolated unilateral zygomaticomaxillary complex fractures: A comprehensive preoperative and postoperative assessment of neurosensory function and quality of life.
INTRODUCTION-The zygomaticomaxillary complex (ZMC) fractures are the second most common fractures affecting the midfacial skeleton.
Neurosensory disturbances of the infraorbital nerve are one of the most common signs of ZMC fractures
AIM AND OBJECTIVE-The aim of the study is to analyse neurosensory changes in the infraorbital nerve following isolated unilateral zygomaticomaxillary complex (ZMC) fracture in both surgically and non surgically managed patients and their quality of life.
The study is planned to assess neurosensory deficits and outcomes in surgically operated and conservatively managed patient after a follow up of 3 months and 6 months with a brief questionnaire to assess their quality of life post trauma.
METHODOLOGY •This is a prospective observational study
•The study includes 20 patients with isolated unilateral ZMC fracture,10 in surgical group and 10 in non surgical group.
INCLUSION CRITERIA-
•Patients diagnosed with isolated unilateral ZMC fractures
•Patient age - 18 years and above
•Patient willing to participate in study.
EXCLUSION CRITERIA-
•Patient with bilateral ZMC fracture, comminuted zygomatic fracture, combined Lefort fractures.
•Patient previous history of neurosensory deficits of the infraorbital nerve.
PARAMETERS ASSESSED
1.Pin prick test
2.Light touch monofilament test
3.Cold thermal test
4.Two point discrimination test
5.Quality of life assessment
Patient assessed –
At time of injury
After 3 months
After 6 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed with isolated unilateral zygomaticomaxillary fractures.
- •Tenderness at fractured points.
- •Visible depression in the prominence of cheek.
- •Patient aged- 18 years and above.
- •Patient willing to participate in study.
排除标准
- •Patient with bilateral ZMC fracture, comminuted zygomatic fractures, combined Lefort fractures.
- •Patient previous history of neurosensory deficits of the infraorbital nerve.
结局指标
主要结局
Neurosensory assessment of infraorbital nerve injury in surgical patients using Pin prick test, cold thermal test, two-point discrimination test, light touch monofilament test, quality of life assessment.
时间窗: Time duration will be measured on sensory assessment of Infraorbital nerve just after the trauma then postoperative 3 months and 6 months after surgery | Day 0 after trauma (Pre operative)Neurosensory Assessment of infraorbital nerve | After 3 months- Post operative Neurosensory assessment of Infraorbital nerve | After 6 Months- Post operative Assessment of Infraorbital nerve.
次要结局
- Neurosensory assessment of infraorbital nerve injury in conservative managed patients using Pin prick test, cold thermal test, two-point discrimination test, light touch monofilament test, quality of life assessment.(Time duration will be measured from after the trauma to conservative management after 3 and 6 months)
研究者
Dr Mridula nair
Thai Moogambigai Dental College and Hospital