Aescin (Reparil) versus Ibuprofen for pain, swelling, and limited mouth opening after impacted lower wisdom tooth removal
Evaluation of Aescin-Based Herbal Extracts for Managing Postoperative Sequelae Following Impacted Mandibular Third Molar Surgery: A Randomized, Single-Blind, Controlled Trial
We will test whether Reparil (aescin) works as well as ibuprofen to reduce pain, swelling, and jaw stiffness after impacted lower wisdom tooth removal in adults aged 18-40.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Oman Medical Speciality Board Government |
| Locations | 1 site (Muscat, Al Khoud) |
| Trial ID | NCT07244029 on ClinicalTrials.gov |
What this trial studies
This is a single-center, randomized, single-blind trial enrolling 100 adults who need surgical removal of impacted mandibular third molars at a dental center in Muscat, Oman. Participants are randomly assigned to Reparil (aescin 20 mg three times daily) or ibuprofen (400 mg three times daily) for five days after a standardized extraction. Outcomes include patient-reported pain (VAS), objective facial swelling measured with a 3D facial scanner, and mouth opening measured with a digital caliper, recorded preoperatively, on day 2, and on day 7 post-surgery. The study also monitors adverse events to compare safety profiles between the herbal extract and the NSAID.
Who should consider this trial
Good fit: Adults aged 18-40 who are ASA I-II and scheduled for surgical removal of similarly positioned impacted mandibular third molars with comparable difficulty scores are ideal candidates.
Not a fit: Patients with contraindications to NSAIDs, known allergies to aescin or ibuprofen, pregnant or lactating women, recent use of anti-inflammatories/corticosteroids/antibiotics, or those with significant systemic disease may not benefit or be eligible.
Why it matters
Potential benefit: If successful, Reparil could provide similar pain and swelling relief to ibuprofen while reducing NSAID-related side effects.
How similar studies have performed: Aescin has shown clinical benefit for soft-tissue edema and venous disorders in other settings, but its use specifically after oral surgical extractions is novel and not extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Muscat, Al Khoud
- Medical City for Military and Security Services - Dental Center — Muscat, Al Khoud, Oman (Recruiting)
Study contacts
- Principal investigator: Suhail H AL Samari, BDS, MFD — Oman Medical Speciality Board
- Study coordinator: Suhail H AlSamari, BDS, MFD
- Email: suhail.dental@gmail.com
- Phone: +968 97366511
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.