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Clinical Trials/NCT06193226
NCT06193226
Completed
Not Applicable

Is Cryotherapy Effective as a Therapeutic Option for Oral Lesion

October 6 University1 site in 1 country15 target enrollmentFebruary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cryotherapy
Sponsor
October 6 University
Enrollment
15
Locations
1
Primary Endpoint
The degree of pain
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2023
End Date
October 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wessam Ibrahim Shehab

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

October 6 University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

The degree of pain

Time Frame: 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

Secondary Outcomes

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

Study Sites (1)

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