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

NCT07244029 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-01-15

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Oman Medical Speciality Board

    lead OTHER_GOV

Principal Investigators

  • Suhail H AL Samari, BDS, MFD · Oman Medical Speciality Board

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2026-07-30
Completion
2026-09-30

Countries

  • Oman

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07244029 on ClinicalTrials.gov