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Is Cryotherapy Effective as a Therapeutic Option for Oral Lesion

Is Cryotherapy Effective as a Therapeutic Option for Oral Lesion

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06193226
Enrollment
15
Registered
2024-01-05
Start date
2023-02-01
Completion date
2023-10-01
Last updated
2024-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cryotherapy, Oral Lesions

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.

Interventions

OTHERCryotherapy

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. 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.

Sponsors

October 6 University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The degree of pain21st days postoperativelyThe 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

MeasureTime frameDescription
Epithelization of the lesion1st month postoperativelyNumber of Participants with epithelization of the lesion was evaluated in the 1st postoperative month
The incidence of recurrence of the lesion2nd month postoperativelyRecurrence of the lesion was evaluated in the 2nd postoperative month

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026