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

January 13, 2026 updated by: Suhail AlSamari, Oman Medical Speciality Board

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Oman
    • Al Khoud
      • Muscat, Al Khoud, Oman, 111
        • Recruiting
        • Medical City for Military and Security Services - Dental Center
        • Sub-Investigator:
          • Vidya Shetty, BDS, MDS
        • Sub-Investigator:
          • Abdullah Al Balushi, BDS, MFD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Suhail H AlSamari, BDS, MFD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aescin (Reparil®) Group
Participants will receive Reparil®-Dragees tablets containing Aescin 20 mg, manufactured by Meda Pharmaceuticals (Germany), administered orally three times daily (TID) for five consecutive days following surgical extraction of an impacted mandibular third molar. A rescue analgesic (Diclofenac potassium 50 mg, Rapidus® by Tabuk Pharmaceutical Manufacturing Co., Saudi Arabia) will be provided if pain is uncontrolled. Clinical assessments will be performed at baseline (preoperatively), on postoperative day 2, and on day 7 for pain (VAS), facial swelling (3D scan), and mouth opening (digital caliper).
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.
Other Names:
  • Reparil®-Dragees
Active Comparator: Ibuprofen Group
Participants will receive Ibuprofen tablets 400 mg, manufactured by Flamingo Pharmaceuticals Ltd. (India), administered orally three times daily (TID) for five consecutive days following surgical extraction of an impacted mandibular third molar. Clinical evaluations will be conducted at baseline, postoperative day 2, and day 7 to assess pain intensity (Visual Analog Scale), facial swelling (3D facial scan), and mouth opening (digital caliper).
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.
Other Names:
  • Ibuprofen 400 mg Tablets BP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain intensity
Time Frame: Baseline, Day 2, and Day 7 post-surgery
Change in pain intensity measured using a 10-point Visual Analog Scale (VAS) at baseline (preoperative), postoperative day 2, and postoperative day 7 following surgical extraction of impacted mandibular third molars.
Baseline, Day 2, and Day 7 post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Facial swelling (edema)
Time Frame: Baseline, Day 2, and Day 7 post-surgery
Change in postoperative facial volume measured using a 3D facial scanner (Revopoint POP 3). Measurements will be taken at baseline (preoperative), postoperative day 2, and postoperative day 7 to assess the degree of facial edema following impacted mandibular third molar surgery.
Baseline, Day 2, and Day 7 post-surgery
Mouth opening (trismus)
Time Frame: Baseline, Day 2, and Day 7 post-surgery
Change in maximum interincisal distance (in millimeters) measured using a digital caliper at baseline (preoperative), postoperative day 2, and postoperative day 7 following surgical extraction of impacted mandibular third molars.
Baseline, Day 2, and Day 7 post-surgery
Adverse effects
Time Frame: Baseline to Day 7 post-surgery
Any drug-related or postoperative adverse effects observed or reported by participants within the 7-day postoperative period will be recorded.
Baseline to Day 7 post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oman Medical Speciality Board

Investigators

  • Principal Investigator: Suhail H AL Samari, BDS, MFD, Oman Medical Speciality Board

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Estimated)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCMSS-MREC 030/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared because the study is a single-center academic clinical trial conducted within a limited institutional setting. Only aggregated and de-identified summary results will be published in peer-reviewed journals and presented at scientific meetings in accordance with institutional and ethical guidelines.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Pain

Clinical Trials on Escin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe