MedTrace Logo

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

NCT07678281 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2026-07-01

No results posted yet for this study

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

Interventions

PROCEDURE

Excision of the OED site with a fiber laser

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.

PROCEDURE

Excision of the OED site with a scalpel

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.

Sponsors & Collaborators

  • I.M. Sechenov First Moscow State Medical University

    lead OTHER

Principal Investigators

  • Michael A Stepanov · : I.M. Sechenov First Moscow State Medical University (Sechenov University)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-28
Primary Completion
2022-12-13
Completion
2025-11-05

Countries

  • Russia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07678281 on ClinicalTrials.gov