NCT07244029

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Oman Medical Speciality Board · Other Government
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Postoperative Pain
• Facial Swelling
• Trismus

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-07-30
• Completion: 2026-09-30
• First posted: 2025-11-24
• Last updated: 2026-01-15

Locations

1 site across 1 country: Oman