Is Cryotherapy Effective as a Therapeutic Option for Oral Lesion

NCT06193226 | Completed

• 1 other identifier: RECO6U/11-2023
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cryotherapy; Oral Lesions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Epithelization of the lesion

  1st month postoperatively

• The incidence of recurrence of the lesion

  2nd month postoperatively

Study Arms (1)

Cryotherapy

EXPERIMENTAL

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.

Other: Cryotherapy

Interventions

Cryotherapy OTHER

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.

Cryotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Both sexes.
• Patients who had benign intraoral epithelial lesions free of infection.

You may not qualify if:

• 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.

Sponsors & Collaborators

• October 6 University: lead

Study Sites (1)

October 6 University

Giza, 12511, Egypt

Location

MeSH Terms

Interventions

Cryotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Oral Medicine and Periodontology Department, Faculty of Dentistry, October 6 University, Egypt

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 5, 2024
• Study Start: February 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)