Neurosensory Deficit of Inferior Alveolar Nerve Following Mandibular Orthognathic Surgery. A Prospective Longitudinal Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pinprick sensation first week
研究概览
简要总结
This clinical study investigates the sensation deficit in the lower lip and chin area after surgical correction of lower jaw deformity.
The primary null hypothesis is: Lower jaw osteotomy cause no sensory deficit in the inferior alveolar nerve.
The secondary null hypothesis is: Concurrent genioplasty with sagittal split does not increase the risk of sensory deficit in the inferior alveolar nerve.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with lower jaw deformity requiring bilateral sagittal split osteotomy
排除标准
- •Medically compromised patients
- •Previous neurosurgical procedure
- •Patients on chronic medications
- •Patients with a mental or psychiatric disorder
- •Pregnant and lactating female
- •Previous neurosensory deficit due to trauma, pathology, or surgery
- •Patients with facial pain disorders including trigeminal neuralgia, temporomandibular disorder, or atypical facial pain
结局指标
主要结局
Pinprick sensation first week
时间窗: One week after the surgery
A tip of sharp dental explorer will be used to measure the pinprick sensation applied to the chin and lower lip area divided into four quadrants: upper right, upper left, lower right, and lower left. The measurement will be recorded as a positive or negative response
Warm/cold test first week
时间窗: One week after the surgery
The measure will be preformed using test tube filled with hot water at temperature 45-50 degrees Celsius, and an ice cube applied to the chin and lower lip area divided into four quadrants: upper right, upper left, lower right, and lower left. The measurement will be recorded as a positive or negative response.
Pinprick sensation three months
时间窗: Three months after the surgery
A tip of sharp dental explorer will be used to measure the pinprick sensation applied to the chin and lower lip area divided into four quadrants: upper right, upper left, lower right, and lower left. The measurement will be recorded as a positive or negative response
Static two points discrimination first month
时间窗: One month after the surgery
A Vernier caliper will be used to measure static two-point discrimination applied to the chin and lower lip area divided into four quadrants: upper right, upper left, lower right, and lower left. Instrument spikes of the caliper will be set open on different separation distances. The score will be recorded as 0 = more than 15 mm, 1 = 10-15 mm, 2 = 9-10 mm, 3 = 7-9 mm, 4 = 6-7 mm, 5 = equal or less than 5 mm.
Light touch sensation first week
时间窗: One week after the surgery
Light touch sensation will be measured using cotton wisp applied to the chin and lower lip area divided into four quadrants: upper right, upper left, lower right, and lower left. The cotton wisp will be in touch with skin in the four quadrants and will be moved in four directions for each quadrant. The score will be recorded as 0 = No response to stimuli, 1= serious perception loss, 2 = hardly perceive sensation, 3 = perceive touch sensation at a lower degree than preoperative, and 4 = normal sensation.
Pinprick sensation first month
时间窗: One month after the surgery
A tip of sharp dental explorer will be used to measure the pinprick sensation applied to the chin and lower lip area divided into four quadrants: upper right, upper left, lower right, and lower left. The measurement will be recorded as a positive or negative response
Warm/cold test first month
时间窗: One month after the surgery
The measure will be preformed using test tube filled with hot water at temperature 45-50 degrees Celsius, and an ice cube applied to the chin and lower lip area divided into four quadrants: upper right, upper left, lower right, and lower left. The measurement will be recorded as a positive or negative response.
Warm/cold test three months
时间窗: Three months after the surgery
The measure will be preformed using test tube filled with hot water at temperature 45-50 degrees Celsius, and an ice cube applied to the chin and lower lip area divided into four quadrants: upper right, upper left, lower right, and lower left. The measurement will be recorded as a positive or negative response.
Light touch sensation first month
时间窗: One month after the surgery
Light touch sensation will be measured using cotton wisp applied to the chin and lower lip area divided into four quadrants: upper right, upper left, lower right, and lower left. The cotton wisp will be in touch with skin in the four quadrants and will be moved in four directions for each quadrant. The score will be recorded as 0 = No response to stimuli, 1= serious perception loss, 2 = hardly perceive sensation, 3 = perceive touch sensation at a lower degree than preoperative, and 4 = normal sensation.
Light touch sensation three months
时间窗: Three months after the surgery
Light touch sensation will be measured using cotton wisp applied to the chin and lower lip area divided into four quadrants: upper right, upper left, lower right, and lower left. The cotton wisp will be in touch with skin in the four quadrants and will be moved in four directions for each quadrant. The score will be recorded as 0 = No response to stimuli, 1= serious perception loss, 2 = hardly perceive sensation, 3 = perceive touch sensation at a lower degree than preoperative, and 4 = normal sensation.
Static two points discrimination first week
时间窗: One week after the surgery
A Vernier caliper will be used to measure static two-point discrimination applied to the chin and lower lip area divided into four quadrants: upper right, upper left, lower right, and lower left. Instrument spikes of the caliper will be set open on different separation distances. The score will be recorded as 0 = more than 15 mm, 1 = 10-15 mm, 2 = 9-10 mm, 3 = 7-9 mm, 4 = 6-7 mm, 5 = equal or less than 5 mm.
Static two points discrimination three months
时间窗: Three months after the surgery
A Vernier caliper will be used to measure static two-point discrimination applied to the chin and lower lip area divided into four quadrants: upper right, upper left, lower right, and lower left. Instrument spikes of the caliper will be set open on different separation distances. The score will be recorded as 0 = more than 15 mm, 1 = 10-15 mm, 2 = 9-10 mm, 3 = 7-9 mm, 4 = 6-7 mm, 5 = equal or less than 5 mm.
次要结局
未报告次要终点
研究者
Ra'ed Salma
Assistant Professor
Riyadh Colleges of Dentistry and Pharmacy