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Набор скоро начнётся NCT07174934

Effect of I-PRF After Gingivectomy

Без фазы С лечением Chronic Inflammatory Gingival Enlargement

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: application of injectable platelet-rich fibrin on the wound area ..
Кому может быть актуально
Состояния в реестре: Chronic Inflammatory Gingival Enlargement. Базовые параметры: 18 лет — 35 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Evaluation of The Effect of Injectable Platelet-Rich Fibrin Application on Wound Healing Following Gingivectomy or Gingivoplasty: Randomized Controlled Clinical Study

Обзор

The goal of this clinical trial is to evaluate the effect of injectable platelet-rich fibrin application on wound healing following gingivectomy or gingivoplasty. The main question it aims to answer are: Does the injectable platelet-rich fibrin enhance the wound healing after gingivectomy or gingivoplasty ? Participants(who have chronic inflammatory gingival overgrowth) will be divided into two groups : Group I: systemically healthy patients with chronic inflammatory gingival enlargement will be randomly treated with gingivectomy or gingivoplasty alone (control). Group II: systemically healthy patients with chronic inflammatory gingival enlargement will be randomly treated with gingivectomy or gingivoplasty and application of injectable platelet rich fibrin on wound area. The patients will be recalled for follow-up appointments on days 7, 14, and 21.

Подробное описание

All participants will receive a full-mouth clinical examination, Initial periodontal therapy and oral hygiene instructions. the patients will be called again 2 weeks later after phase I therapy.

The following periodontal parameters will be recorded: Plaque Index (PI) , Bleeding on probing (BOP) before and after surgery operation at (baseline, 21day).

Prior to the procedure, patients will be rinsed with mouthwash containing 0.12% chlorhexidine. Surgical operations will be carried out with local infiltration anesthesia with vasoconstrictor the gingivectomy or gingivoplasty operation will be done with the conventional method (the procedure of gingivectomy with a #15 scalpel), then Test group: I-PRF is placed on the wound area after a gingivectomy or gingivoplasty with the conventional method and closed with a periodontal dressing.

Control group: closure of the wound area with only a periodontal dressing after a gingivectomy or gingivoplasty with the conventional method.

Post-operative instructions will be given and patients will be asked to avoid brushing at the surgical sites for at least 7 days, 0.2% chlorhexidine gluconate mouthwash twice daily for 14 days will be prescribed.

Clinical follow-up of patients:

The patients will be recalled for follow-up appointments on days 7, 14, and 21. The parameters evaluated in the control sessions were as follows:

1. LTH wound healing index : there are many parameters to assess wound healing, but the Landry, Turnbull, and Hawley Index is easy and convenient to score . It has a scoring range from 1 to 5, the lowest being 1 and the highest being 5. The parameters measured in this index are the healing index, tissue color, bleeding on palpation, granulation tissue, and suppuration . 2. MMS scale : the modified Manchester scar scale (MSS) was used to assess the color, contour, and distortion of the wound .

The color of the wound was classified as a perfect match (score 0), mild mismatch (score 1), or obvious mismatch (score 2) compared with the neighboring mucosa. The contour of the wound was evaluated as similar (score0), slightly raised, or indented (score 1) and hypertrophic (score2) when compared with surrounding tissues. Wound distortion was evaluated as no distortion (score 0), mild distortion (score 1), and obvious distortion (score 2). The sum of the scores in the three categories shows the repair score of the wound, with a total score ranging from 0 to 6, with lower scores indicating better repair. 3. Visual Analog Scale : Assessment patient satisfaction very important so, post operative pain will be evaluated by visual analog scale (VAS) . In this method, the patients will be asked to rate their pain at an examination in form of a score between 0 (no pain) and 100 (the most pain which patient has ever experienced) .

Gingival fluid sampling :

Gingival crevicular fluid (GCF) collection will be done before the operation (at base line), and after the operation (21th day). samples will be collected using sterile paper strips, Paper strips contaminated with blood or saliva will be discarded.

The samples will be assayed for PRL by using an enzyme linked immunosorbent assay (ELISA) kits.

full-mouth clinical examination, Initial periodontal therapy, clinical measurements, surgery operation, gingival crevicular fluid sampling and follow-up evaluations will be performed by the same periodontist.

Вмешательства

  • Биопрепарат application of injectable platelet-rich fibrin on the wound area .
    Injectable platelet-rich fibrin will be prepared using low speed centrifugation technique, after centrifugation, the I-PRF in the upper part of the tube will be collected via an injector and will be transferred to a metal godet. It will be left for 15-20 min for polymerization of the I-PRF ,Then the polymerized I-PRF will be applied to the secondary wound of test area.

Первичные конечные точки

  • Change in gingival crevicular fluid level of Vascular Endothelial Growth Factor (VEGF) at baseline and 21 days after gingivectomy or gingivoplasty. [Срок оценки: at baseline, 21days after gingivectomy.]
Вторичные конечные точки (3)
  • Patient satisfaction using Visual Analog Scale (VAS). [Срок оценки: At 7th ,14th,21th days after gingivectomy.]
  • Clinical wound healing using Landry, Turnbull, and Howley (LTH) Wound Healing Index. [Срок оценки: 7th, 14th, 21st days after gingivectomy.]
  • Clinical wound healing using Modified Manchester Scar (MMS) Scale. [Срок оценки: 7th, 14th, 21st days after gingivectomy.]

Критерии участия

Критерии включения

  • 1- Systemically healthy patients. 2- patients ages18-35years. 3- patients with chronic inflammatory gingival overgrowth. 4- patients with fibrotic gingival overgrowth. 5- Patients with enough attached gingiva. 6- Patients signing informed written consent.

Критерии исключения

\- 1) Pregnancy or lactation. 2) Any known systemic disease. 3) Any type of previous periodontal treatment (surgical or non-surgical) in the preceding 6 months.

4\) smokers and alcohol users 5) clinical attachment or bone loss. 6) Patients run on immunosuppressive agents, systemic corticosteroids, chemotherapy, and/or radiotherapy drugs taken or prescribed 2 months before the study attempt, which may affect the study results, wound healing, and coagulation mechanism.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Out-Patient Clinic of Oral Medicine, Periodontology, Oral Diagnosis and Radiology departme — Cairo

Идентификаторы

NCT: NCT07174934 · P-ME-25-07

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗