Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
All Genders
Healthy Volunteers
NCT07244029

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

Led by Oman Medical Speciality Board · Updated on 2026-01-15

100

Participants Needed

1

Research Sites

38 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 40Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients needing surgical removal of impacted lower wisdom teeth based on NICE guidelines
  • Age between 18 and 40 years
  • Impacted lower wisdom teeth with similar position and difficulty as per Pell and Gregory and Pederson scoring
  • Healthy individuals classified as ASA I-II with no major systemic illnesses
  • Willing to provide written consent and attend follow-up visits on day 2 and day 7 after surgery
Not Eligible

You will not qualify if you...

  • Use of anti-inflammatory drugs, corticosteroids, or antibiotics within three weeks before surgery
  • Known allergy or sensitivity to Aescin, Ibuprofen, rescue medications, or local anesthetics
  • Pregnant or breastfeeding women
  • Conditions contraindicating NSAID use, such as asthma, bleeding disorders, chronic kidney disease, active peptic ulcer, or cardiovascular disease
  • Use of substances like contraceptives, alcohol, or tobacco that may affect surgery or interact with study drugs
  • Surgical procedures lasting more than 30 minutes or with complications requiring non-study medications

AI-Screening

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Trial Site Locations

Total: 1 location

1

Medical City for Military and Security Services - Dental Center

Muscat, Al Khoud, Oman, 111

Actively Recruiting

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Research Team

S

Suhail H AlSamari, BDS, MFD

CONTACT

V

Vidya Shetty, BDS, MDS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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