Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery

Официальное название

Evaluation of Aescin-Based Herbal Extracts for Managing Postoperative Sequelae Following Impacted Mandibular Third Molar Surgery: A Randomized, Single-Blind, Controlled Trial

Обзор

This randomized, single-blind, controlled clinical trial aims to evaluate the efficacy and safety of Aescin-based herbal extract (Reparil®) compared with Ibuprofen in managing postoperative sequelae following surgical removal of impacted mandibular third molars. A total of 100 participants aged 18-40 years will be enrolled at the Dental Center, Medical City Hospital for Military and Security Services (MCMSS), Al Khoud, Oman. Participants will be randomly assigned to receive either Reparil® (Aescin 20 mg, three times daily for five days) or Ibuprofen (400 mg, three times daily for five days) following standardized third molar extraction procedures. Postoperative outcomes including pain (VAS), facial swelling (3D facial scanner), and mouth opening (digital caliper) will be assessed preoperatively, on day 2, and day 7 post-surgery. The study aims to determine whether Aescin offers comparable analgesic and anti-edematous effects to Ibuprofen with fewer adverse events.

Подробное описание

The extraction of impacted mandibular third molars is one of the most common oral surgical procedures and is frequently associated with pain, facial swelling, and trismus. These postoperative sequelae result from an acute inflammatory response triggered by surgical trauma. Nonsteroidal anti-inflammatory drugs (NSAIDs), particularly Ibuprofen, are widely prescribed for symptom control but are often associated with gastrointestinal, renal, and cardiovascular adverse effects. Hence, safer alternatives with comparable efficacy are being investigated.

Aescin, a natural saponin derived from Aesculus hippocastanum (horse chestnut), exhibits anti-inflammatory, anti-edematous, and venotonic properties. It acts by stabilizing capillary membranes, reducing vascular permeability, and inhibiting the release of inflammatory mediators such as histamine and prostaglandins. Reparil tablets containing Aescin have been clinically validated for treating soft tissue edema and chronic venous insufficiency but have not been extensively evaluated in oral surgical applications.

This prospective, single-center, randomized, single-blind controlled trial will compare the postoperative efficacy of Aescin (Reparil) versus Ibuprofen in patients undergoing surgical extraction of impacted mandibular third molars. Participants will be randomly assigned (1:1) into two treatment groups using computer-generated allocation with pharmacist-controlled concealment. Both the operator and the outcome assessor will be blinded to treatment allocation.

Pain intensity will be measured using a 10-point Visual Analog Scale (VAS). Facial swelling will be objectively assessed using a 3D facial scanner (Revopoint POP 3), and trismus will be measured as the maximum interincisal distance. Assessments will be performed at baseline, postoperative day 2, and day 7. A rescue analgesic (diclofenac sodium 50 mg) will be provided for uncontrolled pain.

All data will be recorded via EpiData version 4.6, with statistical analysis conducted using IBM SPSS Statistics version 30.0. The primary endpoint is postoperative pain reduction; secondary endpoints include facial edema, trismus improvement, and adverse drug effects. This study will contribute to evidence on the use of herbal-based anti-inflammatory agents as potential alternatives to conventional NSAIDs in oral surgery.

Вмешательства

• Препарат Escin
  Oral administration of Aescin 20 mg (Reparil®-Dragees, Meda Pharmaceuticals, Germany), taken three times daily (TID) for five consecutive days following surgical extraction of an impacted mandibular third molar. Each tablet contains 20 mg of purified Aescin derived from Aesculus hippocastanum.
• Препарат Ibuprofen 400 mg
  Oral administration of Ibuprofen 400 mg tablets (Flamingo Pharmaceuticals Ltd., India), taken three times daily (TID) for five consecutive days following surgical extraction of an impacted mandibular third molar.

Первичные конечные точки

• Postoperative pain intensity [Срок оценки: Baseline, Day 2, and Day 7 post-surgery]

Вторичные конечные точки (3)

• Facial swelling (edema) [Срок оценки: Baseline, Day 2, and Day 7 post-surgery]
• Mouth opening (trismus) [Срок оценки: Baseline, Day 2, and Day 7 post-surgery]
• Adverse effects [Срок оценки: Baseline to Day 7 post-surgery]

Критерии участия

Критерии включения

• Patients indicated for surgical removal of impacted mandibular third molars according to National Institute for Health and Care Excellence (NICE) guidelines.

Age between 18 and 40 years.

Impacted mandibular third molars with similar anatomical position and difficulty level as classified by Pell and Gregory and Pederson scoring.

Healthy individuals (ASA I-II) with no significant systemic illness.

Willing to provide written informed consent and attend all follow-up visits (Day 2 and Day 7 post-surgery).

Критерии исключения

• Recent use (within three weeks preoperatively) of anti-inflammatories, corticosteroids, or antibiotics.

Known allergies or hypersensitivity to Aescin, Ibuprofen, rescue medications, or local anesthetics.

Pregnant or lactating women.

Patients with contraindications to NSAIDs (e.g., asthma, bleeding disorders, chronic kidney disease, active peptic ulcer, or cardiovascular disease).

Recent use of substances that may affect surgery or interact with study drugs (e.g., contraceptives, alcohol, or tobacco).

Surgical time exceeding 30 minutes or cases with intraoperative complications requiring non-study medications.

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

Oman · 1 центр

• Medical City for Military and Security Services - Dental Center — Muscat

Публикации

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• Wang D, He X, Wang Y, Li Z, Zhu Y, Sun C, Ye J, Jiang H, Cheng J. External root resorption of the second molar associated with mesially and horizontally impacted mandibular third molar: evidence from cone beam computed tomography. Clin Oral Investig. 2017 May;21(4):1335-1342. doi: 10.1007/s00784-016-1888-y. Epub 2016 Jun 18. PMID 27316639
• Ong CK, Lirk P, Tan JM, Sow BW. The analgesic efficacy of intravenous versus oral tramadol for preventing postoperative pain after third molar surgery. J Oral Maxillofac Surg. 2005 Aug;63(8):1162-8. doi: 10.1016/j.joms.2005.04.028. PMID 16094585
• Majid OW, Al-Mashhadani BA. Perioperative bromelain reduces pain and swelling and improves quality of life measures after mandibular third molar surgery: a randomized, double-blind, placebo-controlled clinical trial. J Oral Maxillofac Surg. 2014 Jun;72(6):1043-8. doi: 10.1016/j.joms.2013.12.035. Epub 2014 Jan 16. PMID 24589242

Идентификаторы

NCT: NCT07244029 · MCMSS-MREC 030/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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