October 6 University
Giza, 12511, Egypt
NCT Number: NCT06193226
The aim of this study is to evaluate the effectiveness of cryotherapy as a therapeutic option for oral lesions.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Giza, 12511, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cryotherapy can be done in two ways:
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.
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
Time frame: 1st month postoperatively
Number of Participants with epithelization of the lesion was evaluated in the 1st postoperative month
Time frame: 2nd month postoperatively
Recurrence of the lesion was evaluated in the 2nd postoperative month
October 6 University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07710833
Asymptomatic Irreversible Pulpitis, Cryotherapy
Rize, Centre, Turkey (Türkiye)
View Trial DetailsNCT07198022
Cryotherapy, Healthy
Samsun, Turkey (Türkiye)
View Trial DetailsNCT07134283
Arthritis, Cryotherapy
Ankara, Turkey (Türkiye)
View Trial DetailsNCT06673277
Adverse Effects, Cryotherapy
Winchester, Hampshire, United Kingdom
View Trial Details