Is Cryotherapy Effective as a Therapeutic Option for Oral Lesion

October 6 University

Status: Completed

Conditions: Cryotherapy; Oral Lesions

Treatments: Other: Cryotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06193226

RECO6U/11-2023

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

15 participants in 1 patient group

Cryotherapy

Experimental group

Description:

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.

Treatment:

Other: Cryotherapy