The Relationship Between Interferon Status and HPV Infection in Patients With Oral Epithelial Dysplasia

The Use of Laser Technologies in the Surgical Treatment of Patients With Oral Epithelial Dysplasia

This is an interventional prospective randomized clinical trial (RCT) in parallel groups. The sample size is 74 patients who were randomly divided into two groups depending on the surgical intervention used. First group - patients who underwent surgery to excise the affected oral mucosa with a fiber laser with a wavelength of 1.94 micrometers (LSP-IRE- Polyus, Moscow, Russia). Second group - patients who underwent surgery using the traditional scalpel technique (No. 15C). At the examination stage, patients were referred for evaluation of interferon status according to the following indicators: biological activity of serum interferon (IFN), spontaneous IFN, IFN-alpha/beta, IFN-gamma.

In the postoperative period the dynamics of postoperative epithelialization, the severity of edema, hyperemia and pain syndrome were evaluated. Also, the postoperative material was sent for a molecular genetic study of HPV infection by PCR diagnostics and pathohistological examination followed by immunohistochemical analysis to determine the expression of oncoproteins p16 and p53.

Study Overview

• Status: Completed
• Conditions: Oral Epithelial Dysplasia
• Intervention / Treatment: Procedure: Excision of the OED site with a fiber laser; Procedure: Excision of the OED site with a scalpel

Detailed Description

The aim of this study is to improve the diagnosis and treatment of patients with oral epithelial dysplasia (OED) through the use of laser technologies and monitoring of interferon status, human papillomavirus invasion and oncoprotein expression. Examination and treatment of patients will be carried out on the basis of the Department of Surgical Dentistry of the Borovsky Institute of Dentistry of Sechenov University. The object of the study will be patients with oral potentially malignant diseases with signs of epithelial dysplasia. All patients will be randomly divided into two groups depending on the surgical procedure. In the first group (n=37), areas of the affected oral mucosa will be excised by radiation from a fiber laser with a wavelength of 1.94 micrometers. Patients in the second group (n=37) will undergo surgery using the traditional scalpel technique (No. 15C). The groups will be comparable in terms of gender and age characteristics. Patients will be divided into two groups by random sampling with the same opportunity to receive treatment using a high-intensity laser and a surgical scalpel.

Patients of the first group will undergo excision of the affected oral mucosa within healthy tissues using a fiber laser with a wavelength of 1.94 micrometers in a pulsed-periodic mode with a pulse duration of 100 ms and a pause duration of 100 ms, with a power of 2.5-3.0 watts. The impact on the fabric will be carried out with a freshly split end of the optical fiber after its preliminary activation by short-term contact with a wooden spatula. With a defocused 1.5-watt coagulation laser beam, the wound surface will be treated non-contact until a coagulation film, a "laser bandage," is formed that will cover the entire postoperative area, thus achieving complete hemostasis.

In patients of the second group, excision of the affected oral mucosa will be performed with a scalpel No. 15C within healthy tissues, followed by suturing the surgical area or closing the wound surface with an iodoform swab, fixed sutures.

Postoperative material in both groups will be sent for pathohistological examination. In the postoperative period, it is necessary to prescribe standard antibacterial and anti-inflammatory therapy in combination with the use of local antiseptics for daily care in the early postoperative period.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russia
  • Moscow, Russia
    • I.M. Sechenov First Moscow State Medical University (Sechenov University)

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. The patient's written informed consent to participate in the study;
2. Men and women aged 18-80 years;
3. Verified diagnoses K 13.2 "Leukoplakia and other changes in the oral epithelium", L 43 "Lichen planus" with pathohistological signs of epithelial dysplasia.
4. Patients who, after conservative treatment of lesions of the oral mucosa, have not achieved a therapeutic effect and have indications for surgery.

Non-inclusion criteria:

1. Patients who have achieved the therapeutic effect of the disease after conservative treatment;
2. Patients who have symptoms of malignant transformation and who could not / did not want to make all necessary visits to the doctor;
3. Pregnant women and during lactation, women who planned pregnancy during this study.

Exclusion Criteria:

1. Patient's refusal to continue participating in the study;
2. Pregnancy;
3. The onset of an exacerbation of concomitant pathology;
4. Allergic reaction to medications used;
5. A change in the state of health that, in the researcher's opinion, prevents the patient from continuing to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: first group; Patients undergoing surgery to excise the affected oral mucosa will be treated with a fiber laser with a wavelength of 1.94 micrometers.	Procedure: Excision of the OED site with a fiber laser; Excision of the affected oral mucosa within healthy tissues using a fiber laser with a wavelength of 1.94 micrometers in a pulsed-periodic mode with a pulse duration of 100 ms and a pause duration of 100 ms, with a power of 2.5-3.0 watts.; Using a defocused 1.5 W coagulation laser beam, non-contact laser treatment of the wound surface until a coagulation film or "laser bandage" is formed.; Complete suturing of the wound or its open management.
Experimental: second group; Patients who will have surgery to excise the affected oral mucosa with a scalpel (No. 15C).	Procedure: Excision of the OED site with a scalpel; Excision of the affected oral mucosa will be performed with a scalpel No. 15C within healthy tissues.; Complete suturing of the surgical area or closure of the wound surface with an iodoform swab, fixed sutures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the reduction of the wound surface area	The longitudinal and transverse dimensions of the wound surface will be measured using a dental micrometer. The area of the wound surface will be calculated as the area of the orthogonal projection of the three-dimensional figure onto the plane. Depending on the shape of the wound surface, its projection is considered either as a circle or as an ellipse. The area of the wound surface will be calculated using the formula: S= π R 2 (the area of the circle), S= πab (the area of the ellipse), where R - is the radius of the circle, a - is the major semi-axis, b - is the minor semi-axis of the ellipse, and the number π ≈3.14. The results are expressed in cm2.	[Day 5 compared to the 0th day (initial value)]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the reduction of the wound surface area	The longitudinal and transverse dimensions of the wound surface will be measured using a dental micrometer. The area of the wound surface will be calculated as the area of the orthogonal projection of the three-dimensional figure onto the plane. Depending on the shape of the wound surface, its projection is considered either as a circle or as an ellipse. The area of the wound surface will be calculated using the formula: S= π R 2 (the area of the circle), S= πab (the area of the ellipse), where R - is the radius of the circle, a - is the major semi-axis, b - is the minor semi-axis of the ellipse, and the number π ≈3.14. The results are expressed in cm2.	[Day 3 compared to the 0th day (initial value)]
Assessment of the reduction of the wound surface area	The longitudinal and transverse dimensions of the wound surface will be measured using a dental micrometer. The area of the wound surface will be calculated as the area of the orthogonal projection of the three-dimensional figure onto the plane. Depending on the shape of the wound surface, its projection is considered either as a circle or as an ellipse. The area of the wound surface will be calculated using the formula: S= π R 2 (the area of the circle), S= πab (the area of the ellipse), where R - is the radius of the circle, a - is the major semi-axis, b - is the minor semi-axis of the ellipse, and the number π ≈3.14. The results are expressed in cm2.	[Day 7 compared to the 0th day (initial value)]
Assessment of the collateral edema	Edema will be clinically assessed by its volume (scores 0-2; 0 points - no edema, 1 point - moderate edema, 2 points - intense edema compared to the condition of adjacent tissues).	[Day 1 compared to the 0th day (initial value)]
Assessment of the collateral edema	Edema will be clinically assessed by its volume (scores 0-2; 0 points - no edema, 1 point - moderate edema, 2 points - intense edema compared to the condition of adjacent tissues).	[Day 3 compared to the 0th day (initial value)]
Assessment of the collateral edema	Edema will be clinically assessed by its volume (scores 0-2; 0 points - no edema, 1 point - moderate edema, 2 points - intense edema compared to the condition of adjacent tissues).	[Day 5 compared to the 0th day (initial value).]
Assessment of the collateral edema	Edema will be clinically assessed by its volume (scores 0-2; 0 points - no edema, 1 point - moderate edema, 2 points - intense edema compared to the condition of adjacent tissues).	[Day 7 compared to the 0th day (initial value).]
Assessment of the severity of pain syndrome	A simple descriptive pain intensity scale. Evaluation of the severity of pain syndrome is carried out after surgery using a questionnaire, where : 0 - absence of pain; 1- weak pain; 2 - moderate pain; 3 -severe pain; 4 - extreme pain; 5 - unbearable pain.	[Day 1 compared to the 0th day (initial value)].
Assessment of the severity of pain syndrome	A simple descriptive pain intensity scale. Evaluation of the severity of pain syndrome is carried out after surgery using a questionnaire, where : 0 - absence of pain; 1- weak pain; 2 - moderate pain; 3 -severe pain; 4 - extreme pain; 5 - unbearable pain.	[Day 3 compared to the 0th day (initial value)].
Assessment of the severity of pain syndrome	A simple descriptive pain intensity scale. Evaluation of the severity of pain syndrome is carried out after surgery using a questionnaire, where : 0 - absence of pain; 1- weak pain; 2 - moderate pain; 3 -severe pain; 4 - extreme pain; 5 - unbearable pain.	[Day 5 compared to the 0th day (initial value)].
Assessment of the severity of pain syndrome	A simple descriptive pain intensity scale. Evaluation of the severity of pain syndrome is carried out after surgery using a questionnaire, where : 0 - absence of pain; 1- weak pain; 2 - moderate pain; 3 -severe pain; 4 - extreme pain; 5 - unbearable pain.	[Day 7 compared to the 0th day (initial value)].
Assessment of hyperemia	Hyperemia will be clinically assessed by its severity (points 0-2, where 0 - absence of hyperemia, 1 point - moderate hyperemia, 2 points - pronounced hyperemia).	[Day 1 compared to the 0th day (initial value)].
Assessment of hyperemia	Hyperemia will be clinically assessed by its severity (points 0-2, where 0 - absence of hyperemia, 1 point - moderate hyperemia, 2 points - pronounced hyperemia).	[Day 3 compared to the 0th day (initial value)].
Assessment of hyperemia	Hyperemia will be clinically assessed by its severity (points 0-2, where 0 - absence of hyperemia, 1 point - moderate hyperemia, 2 points - pronounced hyperemia).	[Day 5 compared to the 0th day (initial value)].
Assessment of hyperemia	Hyperemia will be clinically assessed by its severity (points 0-2, where 0 - absence of hyperemia, 1 point - moderate hyperemia, 2 points - pronounced hyperemia).	[Day 7 compared to the 0th day (initial value)]

Collaborators and Investigators

• Sponsor: I.M. Sechenov First Moscow State Medical University
• Investigators: Principal Investigator: Michael A Stepanov, : I.M. Sechenov First Moscow State Medical University (Sechenov University)

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2020
• Primary Completion (Actual): December 13, 2022
• Study Completion (Actual): November 5, 2025

Study Registration Dates

• First Submitted: June 25, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): July 1, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: laser; human papillomavirus; oral epithelial dysplasia; Oral potentially malignant diseases; interferon status; oncoproteins p16, p53
• Other Study ID Numbers: AI-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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