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临床试验/NCT06662331
NCT06662331已完成不适用

Effects of Low Medial Ramus Osteotomy Performed During Bilateral Sagittal Split Osteotomy on Neurosensorial Recovery During Post-Operative Period

Ali Törel Saygı2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2023年1月1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
21
试验地点
2
主要终点
Functional Sensory Recovery

研究概览

简要总结

The aim of this study is to compare the post-operative neurosensorial disturbances of Hunsuck-Epkerr and "low and short medial osteotomy" modifications of sagittal split ramus osteotomy. Patients at the ages of 18-35 with dentofacial deformity who applied for orthognathic surgery were included in the present study. The present study performed with split-mouth randomised controlled trial design, therefore osteotomies on one side were performed with Hunscuk-Epkerr modification and the contralateral side with low and short medial osteotomy modification. Double blinded evaluations of neuro sensorial alterations were performed at the 1st, 3rd and 6th months post-operatively. Painful stimuli, two-point discrimination, pressure and brush stroke direction tests were evaluated. Subjective neurosensorial recovery was also evaluated with VAS scores given by patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with dentofacial deformity who needs orthognatic surgery

排除标准

  • The patients with medical conditions that may affect the potential of nerve regeneration,
  • The patient who need additional osteotomies such as genioplasty or mandibular subapical segmental osteotomies
  • The patients with bad split or interrupted IAN
  • The patients with more than 5 mm expected buccal osseous gap between proximal and distal segments

结局指标

主要结局

Functional Sensory Recovery

时间窗: 6 months

Kind of scale, calculated with different neurosensorial investigation methods. Scored between S0-S4. S0 means total sensory loss, S4 means total sensory recovery.

次要结局

未报告次要终点

研究者

发起方
Ali Törel Saygı
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ali Törel Saygı

Corresponding Author

Bezmialem Vakif University

研究点 (2)

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