Evaluation of Aescin-Based Herbal Extracts for Managing Postoperative Sequelae Following Impacted Mandibular Third Molar Surgery: A Randomized, Single-Blind, Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Postoperative pain intensity
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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).
Intervention: Escin (Drug)
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).
Intervention: Ibuprofen 400 mg (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
Investigators
Suhail AlSamari
Principal Investigator - General Dentistry Resident (OMSB)
Oman Medical Speciality Board