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Набор скоро начнётся NCT07723326

Comparison of Electrocautery and Scalpel Blade Incisions of Impacted Mandibular Third Molars

Без фазы С лечением Impacted Mandibular Third Molar

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: scalpel blade incision, electrocautery incision.
Кому может быть актуально
Состояния в реестре: Impacted Mandibular Third Molar. Базовые параметры: 15 лет — 65 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
Пакистан
Следующий шаг
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Официальное название

Comparison of Electrocautery and Scalpel Blade Incisions on Postoperative Pain, Intraoperative Blood Loss, and Wound Healing Following Surgical Extraction of Impacted Mandibular Third Molars: A Randomized Controlled Trial

Обзор

This randomized controlled trial aims to compare electrocautery and scalpel blade incisions during surgical extraction of impacted mandibular third molars. The study will evaluate postoperative pain, intraoperative blood loss, and wound healing in patients undergoing third molar surgery. A total of 78 participants will be randomly allocated in a 1:1 ratio to receive either a scalpel blade incision or an electrocautery incision under standardized surgical conditions.

Подробное описание

Surgical extraction of impacted mandibular third molars is one of the most common procedures in oral and maxillofacial surgery. The type of incision used may influence postoperative outcomes, including pain, bleeding, and wound healing. Electrocautery offers simultaneous cutting and coagulation, potentially reducing intraoperative blood loss and improving surgical visibility, whereas scalpel incisions produce precise tissue cuts without thermal injury.

This prospective, two-arm, parallel-group, randomized controlled trial will compare electrocautery and scalpel blade incisions in patients undergoing surgical extraction of impacted mandibular third molars. Seventy-eight participants will be randomly assigned to either Arm A (scalpel blade incision) or Arm B (electrocautery incision). All other surgical and perioperative variables, including local anesthesia, flap design, irrigation, suture material, and postoperative medications, will be standardized.

The primary outcome is postoperative pain assessed using a Visual Analogue Scale at 24 hours, 48 hours, and 7 days. Secondary outcomes include intraoperative blood loss and wound healing assessed using the Landry Wound Healing Index at 1 and 4 weeks. The findings of this study will provide evidence regarding the most appropriate incision technique for impacted mandibular third-molar surgery.

Вмешательства

  • Процедура scalpel blade incision
    A sterile No. 15 stainless-steel scalpel blade will be used to make the mucoperiosteal flap incision during surgical extraction of the impacted mandibular third molar.
  • Процедура electrocautery incision
    A fine electrocautery electrode in cutting mode at a standardized effective power setting will be used to make the mucoperiosteal flap incision during surgical extraction of the impacted mandibular third molar.

Первичные конечные точки

  • postoperative pain [Срок оценки: 24 hours, 48 hours, and 7 days after surgery.]
Вторичные конечные точки (2)
  • intraoperative blood loss [Срок оценки: During surgery (from first incision to final suture).]
  • wound healing [Срок оценки: 1 week and 4 weeks after surgery.]

Критерии участия

Критерии включения

  • Male and female patients.
  • Age 15 to 65 years.
  • Patients requiring surgical extraction of an impacted mandibular third molar. Patients classified as ASA I or ASA II.
  • Patients willing to provide written informed consent, or assent with parent/guardian permission where applicable, and attend scheduled follow-up visits

Критерии исключения

  • \* Patients with uncontrolled systemic disease or immuno-compromised status.
  • Patients with bleeding disorders or those taking anticoagulant/antiplatelet drugs that cannot be safely withheld according to physician advice.
  • Patients with pacemaker or implanted electrical cardiac device.
  • Pregnant or lactating patients.
  • Patients with acute infection, pericoronitis, facial space infection, or pus discharge at the surgical site at the time of surgery.
  • Patients requiring bilateral third-molar extraction in the same sitting.
  • Patients unwilling to participate or unable to return for follow-up.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Пакистан · 1 центр
  • Islamic International Dental Hospital — Islamabad

Идентификаторы

NCT: NCT07723326 · IIDC/IRC/2026/7/001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗