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

NCT07678281 | Completed

• 1 other identifier: AI-06
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Epithelial Dysplasia

Keywords

Oral potentially malignant diseases; oral epithelial dysplasia; laser; interferon status; human papillomavirus; oncoproteins p16, p53

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Assessment of the reduction of the wound surface area

  [Day 3 compared to the 0th day (initial value)]

• Assessment of the reduction of the wound surface area

  [Day 7 compared to the 0th day (initial value)]

• Assessment of the collateral edema

  [Day 1 compared to the 0th day (initial value)]

• Assessment of the collateral edema

  [Day 3 compared to the 0th day (initial value)]

• Assessment of the collateral edema

  [Day 5 compared to the 0th day (initial value).]

Study Arms (2)

first group

ACTIVE COMPARATOR

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

second group

EXPERIMENTAL

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

Interventions

Excision of the OED site with a fiber laser PROCEDURE

1. 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. 2. 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. 3. Complete suturing of the wound or its open management.

first group

Excision of the OED site with a scalpel PROCEDURE

1. Excision of the affected oral mucosa will be performed with a scalpel No. 15C within healthy tissues. 2. Complete suturing of the surgical area or closure of the wound surface with an iodoform swab, fixed sutures.

second group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient's written informed consent to participate in the study;
• Men and women aged 18-80 years;
• Verified diagnoses K 13.2 "Leukoplakia and other changes in the oral epithelium", L 43 "Lichen planus" with pathohistological signs of epithelial dysplasia.
• Patients who, after conservative treatment of lesions of the oral mucosa, have not achieved a therapeutic effect and have indications for surgery.
• Patients who have achieved the therapeutic effect of the disease after conservative treatment;
• Patients who have symptoms of malignant transformation and who could not / did not want to make all necessary visits to the doctor;
• Pregnant women and during lactation, women who planned pregnancy during this study.

You may not qualify if:

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

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

I.M. Sechenov First Moscow State Medical University (Sechenov University)

Moscow, Russia

Location

Study Officials

• Michael A Stepanov

  : I.M. Sechenov First Moscow State Medical University (Sechenov University)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 1, 2026
• Study Start: November 28, 2020
• Primary Completion: December 13, 2022
• Study Completion: November 5, 2025
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)