The Relationship Between Interferon Status and HPV Infection in Patients With Oral Epithelial Dysplasia
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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Moscow、ロシア
- I.M. Sechenov First Moscow State Medical University (Sechenov University)
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：first group
Patients undergoing surgery to excise the affected oral mucosa will be treated with a fiber laser with a wavelength of 1.94 micrometers.
|
|
|
実験的：second group
Patients who will have surgery to excise the affected oral mucosa with a scalpel (No. 15C).
|
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Assessment of the reduction of the wound surface area
時間枠：[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. |
[Day 5 compared to the 0th day (initial value)]
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Assessment of the reduction of the wound surface area
時間枠：[Day 3 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. |
[Day 3 compared to the 0th day (initial value)]
|
|
Assessment of the reduction of the wound surface area
時間枠：[Day 7 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. |
[Day 7 compared to the 0th day (initial value)]
|
|
Assessment of the collateral edema
時間枠：[Day 1 compared to the 0th day (initial value)]
|
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).
|
[Day 1 compared to the 0th day (initial value)]
|
|
Assessment of the collateral edema
時間枠：[Day 3 compared to the 0th day (initial value)]
|
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).
|
[Day 3 compared to the 0th day (initial value)]
|
|
Assessment of the collateral edema
時間枠：[Day 5 compared to the 0th day (initial value).]
|
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).
|
[Day 5 compared to the 0th day (initial value).]
|
|
Assessment of the collateral edema
時間枠：[Day 7 compared to the 0th day (initial value).]
|
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).
|
[Day 7 compared to the 0th day (initial value).]
|
|
Assessment of the severity of pain syndrome
時間枠：[Day 1 compared to the 0th day (initial value)].
|
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.
|
[Day 1 compared to the 0th day (initial value)].
|
|
Assessment of the severity of pain syndrome
時間枠：[Day 3 compared to the 0th day (initial value)].
|
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.
|
[Day 3 compared to the 0th day (initial value)].
|
|
Assessment of the severity of pain syndrome
時間枠：[Day 5 compared to the 0th day (initial value)].
|
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.
|
[Day 5 compared to the 0th day (initial value)].
|
|
Assessment of the severity of pain syndrome
時間枠：[Day 7 compared to the 0th day (initial value)].
|
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.
|
[Day 7 compared to the 0th day (initial value)].
|
|
Assessment of hyperemia
時間枠：[Day 1 compared to the 0th day (initial value)].
|
Hyperemia will be clinically assessed by its severity (points 0-2, where 0 - absence of hyperemia, 1 point - moderate hyperemia, 2 points - pronounced hyperemia).
|
[Day 1 compared to the 0th day (initial value)].
|
|
Assessment of hyperemia
時間枠：[Day 3 compared to the 0th day (initial value)].
|
Hyperemia will be clinically assessed by its severity (points 0-2, where 0 - absence of hyperemia, 1 point - moderate hyperemia, 2 points - pronounced hyperemia).
|
[Day 3 compared to the 0th day (initial value)].
|
|
Assessment of hyperemia
時間枠：[Day 5 compared to the 0th day (initial value)].
|
Hyperemia will be clinically assessed by its severity (points 0-2, where 0 - absence of hyperemia, 1 point - moderate hyperemia, 2 points - pronounced hyperemia).
|
[Day 5 compared to the 0th day (initial value)].
|
|
Assessment of hyperemia
時間枠：[Day 7 compared to the 0th day (initial value)]
|
Hyperemia will be clinically assessed by its severity (points 0-2, where 0 - absence of hyperemia, 1 point - moderate hyperemia, 2 points - pronounced hyperemia).
|
[Day 7 compared to the 0th day (initial value)]
|
協力者と研究者
捜査官
- 主任研究者：Michael A Stepanov、: I.M. Sechenov First Moscow State Medical University (Sechenov University)
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- AI-06
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。