Clinical Trial

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

Completed
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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.
Trial Details
NCT Number NCT07678281
Lead Sponsor I.M. Sechenov First Moscow State Medical University
Conditions Oral Epithelial Dysplasia
Enrollment 74 participants
Start Date 2020-11-28
Primary Completion 2022-12-13 (estimated)
Study Completion 2025-11-05 (estimated)
Updated on ClinicalTrials.gov 2026-07-01