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

NCT07244029 | Recruiting

• 1 other identifier: MCMSS-MREC 030/2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain; Facial Swelling; Trismus

Keywords

Aescin; Escin; Reparil; Ibuprofen; Herbal anti-inflammatory; Postoperative sequelae; Third molar extraction; Oral surgery; Phytotherapeutic agents; Pain management

Outcome Measures

Primary Outcomes (1)

• Postoperative pain intensity

  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 Outcomes (3)

• Facial swelling (edema)

  Baseline, Day 2, and Day 7 post-surgery

• Mouth opening (trismus)

  Baseline, Day 2, and Day 7 post-surgery

• Adverse effects

  Baseline to Day 7 post-surgery

Study Arms (2)

Aescin (Reparil®) Group

EXPERIMENTAL

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

Ibuprofen Group

ACTIVE COMPARATOR

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

Interventions

Escin DRUG

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.

Also known as: Reparil®-Dragees

Aescin (Reparil®) Group

Ibuprofen 400 mg DRUG

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.

Also known as: Ibuprofen 400 mg Tablets BP

Ibuprofen Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oman Medical Speciality Board: lead

Study Sites (1)

Medical City for Military and Security Services - Dental Center

Muscat, Al Khoud, 111, Oman

RECRUITING

Related Publications (17)

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  PMID: 12638400 BACKGROUND

• 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 BACKGROUND

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• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Gaspani L, Limiroli E, Ferrario P, Bianchi M. In vivo and in vitro effects of bromelain on PGE(2) and SP concentrations in the inflammatory exudate in rats. Pharmacology. 2002 May;65(2):83-6. doi: 10.1159/000056191.

  PMID: 11937778 BACKGROUND

• Bataineh AB, Batarseh RA. The effect of modified surgical flap design for removal of lower third molars on lingual nerve injury. Clin Oral Investig. 2017 Jul;21(6):2091-2099. doi: 10.1007/s00784-016-1999-5. Epub 2016 Nov 12.

  PMID: 27837346 BACKGROUND

• Graziani F, D'Aiuto F, Gennai S, Petrini M, Nisi M, Cirigliano N, Landini L, Bruno RM, Taddei S, Ghiadoni L. Systemic Inflammation after Third Molar Removal: A Case-Control Study. J Dent Res. 2017 Dec;96(13):1505-1512. doi: 10.1177/0022034517722775. Epub 2017 Jul 31.

  PMID: 28759304 BACKGROUND

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• Gallelli L. Escin: a review of its anti-edematous, anti-inflammatory, and venotonic properties. Drug Des Devel Ther. 2019 Sep 27;13:3425-3437. doi: 10.2147/DDDT.S207720. eCollection 2019.

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• Singhai A, Kambala R, Bhola N. Comparison of the efficacy of aescin and diclofenac sodium in the management of postoperative sequelae and their effect on salivary Prostaglandin E2 and serum C-reactive protein levels after surgical removal of impacted mandibular third molar: a randomized, double-blind, controlled clinical trial. F1000Res. 2024 Oct 30;13:106. doi: 10.12688/f1000research.145643.3. eCollection 2024.

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MeSH Terms

Conditions

Pain, Postoperative; Trismus; Agnosia

Interventions

Escin; Ibuprofen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Spasm; Neuromuscular Manifestations; Nervous System Diseases; Perceptual Disorders; Neurobehavioral Manifestations

Intervention Hierarchy (Ancestors)

Pentacyclic Triterpenes; Triterpenes; Terpenes; Hydrocarbons; Organic Chemicals; Saponins; Glycosides; Carbohydrates; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Suhail H AL Samari, BDS, MFD

  Oman Medical Speciality Board

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suhail H AlSamari, BDS, MFD

CONTACT

+968 97366511; suhail.dental@gmail.com

Vidya Shetty, BDS, MDS

CONTACT

+968 93681986; shettyvidya007@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Single-masked: the care provider (surgeon) and the outcomes assessor are blinded to group allocation. Participants are not blinded due to differences in appearance of study medications. Allocation concealment is maintained by coded medication packs prepared by an independent pharmacist.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - General Dentistry Resident (OMSB)

Model Details: Two-arm, parallel-group, randomized, single-blind controlled clinical trial comparing Reparil (Aescin 20 mg TID) versus Ibuprofen 400 mg TID following surgical extraction of impacted mandibular third molars.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

OM (1)