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临床试验/NCT06193226
NCT06193226已完成不适用

Is Cryotherapy Effective as a Therapeutic Option for Oral Lesion

October 6 University2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年2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
15
试验地点
2
主要终点
The degree of pain

研究概览

简要总结

The aim of this study is to evaluate the effectiveness of cryotherapy as a therapeutic option for oral lesions.

详细描述

Low-temperature applications were originally employed by the Egyptians to treat pain, and subsequently during the Franco-Prussian War for severed limbs. Hippocrates advocated the application of cold to lessen bruising, bleeding, and discomfort, while John Hunter wrote in 1777 that "the local tissue response to freezing includes local tissue necrosis, vascular stasis, and excellent healing." Using a solution of salt and ice, James Arnott (1851) was the first to describe and demonstrate this freezing technique for malignant breast tumors.

The term "cryotherapy" was used in 1908 to describe the use of extremely low temperatures to cure skin lesions. Currently, cryotherapy involves cooling the body's surface without destroying tissue, whereas in cryosurgery, sick tissues are frozen to death.

In the technique, several cryogens include: liquid nitroglycerine (-196 °C), Nitrous oxide (0°C), Solid CO2 (-78o C), Chlorodifluoromethane (-41°C), Dimethyl ether (-24 °C) and propane (-42 °C).

The intralesional technique, open method, or closed method can all be used to apply cryogens. The best application approach for big superficial cutaneous lesions is an open spray technique, in which the spray's nozzle is situated 1 cm away from the skin's surface, and the lesion is destroyed using either a paintbrush technique or a spiral technique.

研究设计

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

入排标准

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

入选标准

  • Age ≥ 18 years.
  • Both sexes.
  • Patients who had benign intraoral epithelial lesions free of infection.

排除标准

  • Patients with Reynaud's illness.
  • Cold sensitivity.
  • History of diabetes.
  • Severe infections.
  • Patients who had cryoglobulinemia.
  • Cold urticaria.
  • Patients who was receiving hemodialysis.
  • Patients who was receiving immunosuppressive medication.

结局指标

主要结局

The degree of pain

时间窗: 21st days postoperatively

The degree of pain was assessed by using Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"), which was documented on the 1st, 3rd, 7th, 21st days after the procedure

次要结局

  • Epithelization of the lesion(1st month postoperatively)
  • The incidence of recurrence of the lesion(2nd month postoperatively)

研究者

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

Wessam Ibrahim Shehab

Lecturer of Oral Medicine and Periodontology Department, Faculty of Dentistry, October 6 University, Egypt

October 6 University

研究点 (2)

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