Oral Epithelial DysplasiaNCT07678281
The Relationship Between Interferon Status and HPV Infection in Patients With Oral Epithelial Dysplasia
A study testing Excision of the OED site with a fiber laser and Excision of the OED site with a scalpel in people with Oral Epithelial Dysplasia, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Oral Epithelial Dysplasia
- What is being tested?
- Excision of the OED site with a fiber laser and Excision of the OED site with a scalpel
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteRussia
- Study dates
- 28 Nov 2020to 5 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Non-inclusion criteria:
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Moscow
About this study
Official title: 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.
Read the 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.
- Conditions
- Oral Epithelial Dysplasia
- Being tested
- Excision of the OED site with a fiber laser, Excision of the OED site with a scalpel
- Keywords
- Oral potentially malignant diseases, oral epithelial dysplasia, laser, interferon status, human papillomavirus, oncoproteins p16, p53
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Excision of the OED site with a fiber laserProcedure or surgery
- 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.
Excision of the OED site with a scalpelProcedure or surgery
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Procedure: Excision of the OED site with a scalpel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: [Day 5 compared to the 0th day (initial value)]
Secondary outcomes (14)
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.
Measured: [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.
Measured: [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).
Measured: [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).
Measured: [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).
Measured: [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).
Measured: [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.
Measured: [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.
Measured: [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.
Measured: [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.
Measured: [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).
Measured: [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).
Measured: [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).
Measured: [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).
Measured: [Day 7 compared to the 0th day (initial value)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start28 Nov 2020
- Primary completion13 Dec 2022
- Study completion5 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Epithelial DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael A Stepanov, Principal investigator, : I.M. Sechenov First Moscow State Medical University (Sechenov University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678281
- Sponsor's protocol ID
- AI-06
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Laser Technologies in the Surgical Treatment of Patients With Oral Epithelial Dysplasia
- ClinicalTrials.gov ID
- NCT07678281
- Acronym / sponsor ID
- AI-06
- Conditions
- Oral Epithelial Dysplasia
- Keywords
- Oral potentially malignant diseases, oral epithelial dysplasia, laser, interferon status, human papillomavirus, oncoproteins p16, p53
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 28 Nov 2020 (actual)
- Primary completion
- 13 Dec 2022 (actual)
- Study completion
- 5 Nov 2025 (actual)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| first group | Active comparator | Procedure: Excision of the OED site with a fiber laserPatients undergoing surgery to excise the affected oral mucosa will be treated with a fiber laser with a wavelength of 1.94 micrometers. |
| second group | Experimental | Procedure: Excision of the OED site with a scalpelPatients who will have surgery to excise the affected oral mucosa with a scalpel (No. 15C). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Excision of the OED site with a fiber laser1. 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 or surgery | first group |
| Excision of the OED site with a scalpel1. 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. | Procedure or surgery | second group |
Primary outcome
Assessment of the reduction of the wound surface area
Time frame: [Day 5 compared to the 0th day (initial value)]
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.
14 secondary outcomes
Assessment of the reduction of the wound surface area
Time frame: [Day 3 compared to the 0th day (initial value)]
Assessment of the reduction of the wound surface area
Time frame: [Day 7 compared to the 0th day (initial value)]
Assessment of the collateral edema
Time frame: [Day 1 compared to the 0th day (initial value)]
Assessment of the collateral edema
Time frame: [Day 3 compared to the 0th day (initial value)]
Assessment of the collateral edema
Time frame: [Day 5 compared to the 0th day (initial value).]
Assessment of the collateral edema
Time frame: [Day 7 compared to the 0th day (initial value).]
Assessment of the severity of pain syndrome
Time frame: [Day 1 compared to the 0th day (initial value)].
Assessment of the severity of pain syndrome
Time frame: [Day 3 compared to the 0th day (initial value)].
Assessment of the severity of pain syndrome
Time frame: [Day 5 compared to the 0th day (initial value)].
Assessment of the severity of pain syndrome
Time frame: [Day 7 compared to the 0th day (initial value)].
Assessment of hyperemia
Time frame: [Day 1 compared to the 0th day (initial value)].
Assessment of hyperemia
Time frame: [Day 3 compared to the 0th day (initial value)].
Assessment of hyperemia
Time frame: [Day 5 compared to the 0th day (initial value)].
Assessment of hyperemia
Time frame: [Day 7 compared to the 0th day (initial value)]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A Stepanov principal investigator
: I.M. Sechenov First Moscow State Medical University (Sechenov University)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Excision of the OED site with a fiber laser and Excision of the OED site with a scalpel in people with Oral Epithelial Dysplasia, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the reduction of the wound surface area (time frame: [Day 5 compared to the 0th day (initial value)]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.