Is Cryotherapy Effective as a Therapeutic Option for Oral Lesion

Not Applicable

Completed

• Conditions: Cryotherapy; Oral Lesions
• Interventions: Other: Cryotherapy

• Registration Number: NCT06193226
• Lead Sponsor: October 6 University

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.

Study Timeline

• Study Start: 2023-02-01
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-01
• Study First Submitted: 2023-12-21
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-04
• Study First Posted: 2024-01-05
• Last Update Submitted: 2024-01-06
• Last Update Posted: 2024-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cryotherapy	Cryotherapy	Cryotherapy can be done in two ways: 1. Open technique: Using cotton swabs or a cryogun spray, the cryogen is delivered directly to the lesion in this technique. 2. Closed technique: Cryo-probes are used to apply the cryogen to the lesion in this procedure.

Primary Outcome Measures

Name	Time	Method
The degree of pain	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 Outcome Measures

Name	Time	Method
The incidence of recurrence of the lesion	2nd month postoperatively	Recurrence of the lesion was evaluated in the 2nd postoperative month
Epithelization of the lesion	1st month postoperatively	Number of Participants with epithelization of the lesion was evaluated in the 1st postoperative month

Trial Locations

Locations (1)

October 6 University; 🇪🇬 Giza, Egypt