Status:
RECRUITING
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Lead Sponsor:
Oman Medical Speciality Board
Conditions:
Postoperative Pain
Facial Swelling
Eligibility:
All Genders
18-40 years
Phase:
NA
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 f...
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...
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.
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07244029
Start Date
January 1 2026
End Date
September 30 2026
Last Update
January 15 2026
Active Locations (1)
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1
Medical City for Military and Security Services - Dental Center
Muscat, Al Khoud, Oman, 111