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Recruiting NCT07244029

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

Conditions: Postoperative Pain, Facial Swelling, Trismus

Sex: All
Ages: 18 Years – 40 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 100
Sponsor: Oman Medical Speciality Board

Location: Medical City for Military and Security Services - Dental Center Muscat Al Khoud

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.

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07244029). StuddyBuddy aggregates publicly available trial information.