Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Escin, Ibuprofen 400 mg.
- Who it may be relevant to
- Registry conditions: Postoperative Pain, Facial Swelling, Trismus. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Oman
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Aescin-Based Herbal Extracts for Managing Postoperative Sequelae Following Impacted Mandibular Third Molar Surgery: A Randomized, Single-Blind, Controlled Trial
Overview
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.
Interventions
- 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.
Primary outcome measures
- Postoperative pain intensity [Time frame: Baseline, Day 2, and Day 7 post-surgery]
Secondary outcome measures (3)
- Facial swelling (edema) [Time frame: Baseline, Day 2, and Day 7 post-surgery]
- Mouth opening (trismus) [Time frame: Baseline, Day 2, and Day 7 post-surgery]
- Adverse effects [Time frame: Baseline to Day 7 post-surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Oman · 1 center
- Medical City for Military and Security Services - Dental Center — Muscat
Publications
- Bjornsson GA, Haanaes HR, Skoglund LA. Ketoprofen 75 mg qid versus acetaminophen 1000 mg qid for 3 days on swelling, pain, and other postoperative events after third-molar surgery. J Clin Pharmacol. 2003 Mar;43(3):305-14. doi: 10.1177/0091270002250603. PMID 12638400
- Al-Khateeb TH, Nusair Y. Effect of the proteolytic enzyme serrapeptase on swelling, pain and trismus after surgical extraction of mandibular third molars. Int J Oral Maxillofac Surg. 2008 Mar;37(3):264-8. doi: 10.1016/j.ijom.2007.11.011. Epub 2008 Feb 12. PMID 18272344
- Lokken P, Olsen I, Bruaset I, Norman-Pedersen K. Bilateral surgical removal of impacted lower third molar teeth as a model for drug evaluation: a test with ibuprofen. Eur J Clin Pharmacol. 1975 Apr 4;8(3-4):209-16. doi: 10.1007/BF00567117. PMID 786680
- Yamashita Y, Sano N, Shimohira D, Danjo A, Goto M. A parallel-group comparison study of celecoxib with loxoprofen sodium in third mandibular molar extraction patients. Int J Oral Maxillofac Surg. 2014 Dec;43(12):1509-13. doi: 10.1016/j.ijom.2014.09.002. Epub 2014 Sep 28. PMID 25270186
- Olmedo MV, Galvez R, Vallecillo M. Double-blind parallel comparison of multiple doses of ketorolac, ketoprofen and placebo administered orally to patients with postoperative dental pain. Pain. 2001 Feb 1;90(1-2):135-41. doi: 10.1016/s0304-3959(00)00396-1. PMID 11166979
- 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
Identifiers
NCT: NCT07244029 · MCMSS-MREC 030/2025