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Идёт набор NCT06806241

Effects of Tranexamic Acid Irrigation on Impacted Third Molar Surgery

Наблюдательное Bleeding Tooth Extraction

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: Tranexamic acid, saline irrigation.
Кому может быть актуально
Состояния в реестре: Bleeding, Tooth Extraction. Базовые параметры: 14 лет — 40 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
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Investigation of the Effects of Tranexamic Acid Solution Irrigation on Bleeding, Surgical Field Visibility, and Postoperative Edema in the Extraction of Horizontally Impacted Third Molars

Обзор

Tranexamic acid (TXA) is an effective hemostatic agent used to reduce blood loss and the need for transfusion. It is a relatively safe drug with minimal significant side effects. The most commonly reported complications include nausea, diarrhea, and occasional orthostatic reactions. The increased risk of thromboembolic events associated with the drug is the most serious complication; however, this has not been reported in most clinical studies and remains uncertain. Based on experience from other types of surgeries, tranexamic acid appears to be safe for use without an increased risk of venous thrombosis. To mitigate systemic absorption and minimize undesirable side effects, TXA can be applied topically rather than intravenously, reducing the risk of venous thromboembolism.

Подробное описание

Topical TXA irrigation has recently begun to be used intraoperatively. In a study conducted by Eftekharian et al., the application of intraoperative 1% TXA irrigation solution during bimaxillary orthognathic surgery was found to be significantly associated with a reduction in intraoperative blood loss compared to placebo. Additionally, the topical application of TXA to the maxillary sinus during endoscopic sinus surgery has been shown to reduce intraoperative blood loss. In the current literature, the use of tranexamic acid irrigation during tooth extraction under local anesthesia has not been reported. Our study aims to demonstrate the effectiveness of TXA irrigation during the extraction of bone-retained teeth and its effect on postoperative edema.

Вмешательства

  • Препарат Tranexamic acid
    in the study group, a combination of two ampules of Tranexamic acid solution mixed with saline will be used. Intraoperative bleeding, surgical field visibility, and postoperative edema will be monitored.
  • Препарат saline irrigation
    In control group, saline will be used for irrigation.Intraoperative bleeding, surgical field visibility, and postoperative edema will be monitored.

Первичные конечные точки

  • postoperative edema [Срок оценки: 3 days]
Вторичные конечные точки (2)
  • intraoperative bleeding [Срок оценки: during the surgery time]
  • intraoperative vision scale [Срок оценки: during the surgery]

Критерии участия

Критерии включения

  • Indicated for the Extraction of Bilaterally Impacted Third Molars with Bone Retention.
  • Systemically healthy patients aged 14-40 years with no bleeding disorders.

Критерии исключения

  • Patients with systemic diseases affecting general health.
  • Patients diagnosed with any bleeding disorder.
  • Patients with advanced infection or cysts associated with the impacted tooth.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Turkey (Türkiye) · 1 центр
  • Bezmialem Vakıf Universty — Istanbul

Идентификаторы

NCT: NCT06806241 · E.142551

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗