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Completed
NCT07678281
The Relationship Between Interferon Status and HPV Infection in Patients With Oral Epithelial Dysplasia
Conditions: Oral Epithelial Dysplasia
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 74
Sponsor: I.M. Sechenov First Moscow State Medical University
Location: I.M. Sechenov First Moscow State Medical University (Sechenov University) Moscow
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07678281). StuddyBuddy aggregates publicly available trial information.