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临床试验/NCT06661798
NCT06661798已完成不适用

Evaluation of Changes in Mental Foramen Blood Flow After Orthognathic Surgery Using Ultrasound

Bezmialem Vakif University2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
Changes in blood flow in the mental foramen after orthognathic surgery

研究概览

简要总结

Objective: This study aims to detect changes in blood flow in the mental foramen after surgery compared to before orthognathic surgery.

Materials and Methods: This study will include a total of 16 patients, aged between 18-60, who were planned for orthognathic surgery due to malocclusion complaints. Patients will be evaluated clinically and radiologically before surgery, 1 week, 1 month, and 3 months after the surgery. Panoramic radiographs will be taken before surgery and 3 months after surgery, and a fractal analysis of the ROI area determined distal to the mental foramen will be performed. Pain will be scored from 1 to 5 using the Pinprick test before surgery, 1 week, 1 month, and 3 months after surgery, while pressure and neurosensitivity will be scored using VAS. Neurosensory evaluation will be performed using two-point discrimination (dividing the area between the lower lip and chin into 9 regions), and left-right discrimination will be checked using the brush test. Blood flow in the mental foramen will be evaluated using ultrasonography.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients over 18 years old,
  • Patients who have reached skeletal maturity,
  • Patients under 60 years old,
  • Patients with skeletal Class II malocclusion indicated for orthognathic surgery,
  • Patients with skeletal Class III malocclusion indicated for orthognathic surgery,
  • Those who are willing to participate in the study

排除标准

  • Patients with a systemic disease,
  • Patients under 18 years old,
  • Patients who have not completed their growth and development,
  • Patients over 59 years old,
  • Patients using neurological and psychiatric medications,
  • Patients who have previously undergone surgery or experienced trauma in the mandibular region,
  • Patients with neurosensory dysfunction in the inferior alveolar nerve before surgery,
  • Pregnant individuals or those suspected of being pregnant,
  • Any local or systemic condition that may contraindicate general anesthesia

结局指标

主要结局

Changes in blood flow in the mental foramen after orthognathic surgery

时间窗: From enrollment to 3 months after the end of surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elifhan Alagoz

Assistant Professor

Bezmialem Vakif University

研究点 (2)

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