Is Cryotherapy Effective as a Therapeutic Option for Oral Lesion

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

Study Overview

• Status: Completed
• Conditions: Cryotherapy; Oral Lesions
• Intervention / Treatment: Other: Cryotherapy

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12511
    • October 6 University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Other: Cryotherapy; Cryotherapy can be done in two ways: Open technique: Using cotton swabs or a cryogun spray, the cryogen is delivered directly to the lesion in this technique.; Closed technique: Cryo-probes are used to apply the cryogen to the lesion in this procedure. The spray's nozzle of the Cryogun spray -50 ◦C was situated 1 cm away from the skin's surface and applied on the oral lesion for 30 seconds. Each freezing cycle lasted 10 to 30 seconds, with the subsequent 60-second thaw interval lasting twice as long as the freezing time. The ice ball that formed during freezing was totally melted before the subsequent freezing process could begin. The application process should went from the core out to the edges. The management of lesions that are too big to be frozen by a single spray requires many overlapping treatments of liquid nitrogen. Mucoceles and erosive lichen planus took 30 to 50 seconds to freeze, whereas fibromas and leukoplakia took 60 to 70 seconds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The degree of pain	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	21st days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of recurrence of the lesion	Recurrence of the lesion was evaluated in the 2nd postoperative month	2nd month postoperatively
Epithelization of the lesion	Number of Participants with epithelization of the lesion was evaluated in the 1st postoperative month	1st month postoperatively

Collaborators and Investigators

• Sponsor: October 6 University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: December 21, 2023
• First Submitted That Met QC Criteria: January 4, 2024
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 6, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: RECO6U/11-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No