Sensory Retraining Exercise Facilitates Sensory Recovery After Bilateral Sagittal Split Osteotomy - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- sensory function test
研究概览
简要总结
The purpose of this study is to determine whether sensory retraining exercise could improve lip numbness caused by bilateral sagittal split of mandible.
详细描述
The study is a prospective randomized controlled trial. The patients receiving bilateral sagittal split osteotomy and having lip numbness or paraesthesia will be included in this study. 80 patients will be included and randomized into two groups and there are 40 patients in each group. The control group is to maintain follow up in clinic and do not receive any sensory retraining exercise. The experimental group is requested to perform sensory retraining at home by themselves.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Taiwanese adult (18-40 y/o)
- •Developmental dentofacial disharmony (Class III)
- •Patients received orthognathic surgery (BSSO alone or with maxillary procedure)
排除标准
- •Medical condition associated with systemic neuropathy
- •Unwilling to sign informed consent
- •Congenital anomaly or acute trauma affecting the face
- •Previous facial surgery
- •Positive pain sensation at first week of post-surgery
- •Altered sensation before OGS as numbness or unusual feeling
- •Cleft lip and palate
结局指标
主要结局
sensory function test
时间窗: one year after surgery
The sensory function evaluation include objective and subjective examinations as the followings: 1. Questionnaire 2. Visual analogue scale (VAS) 3. Two-point discrimination (2PD) 4. Pain detection threshold (PD) tests 5. Touch sensory threshold
次要结局
未报告次要终点