An interventional study of Escin and Ibuprofen 400 mg in Postoperative Pain, Facial Swelling and Trismus, sponsored by Oman Medical Speciality Board. Recruiting at 1 site in Oman. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Oman Medical Speciality Board · Not applicable, Interventional, and Treatment
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.
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 result from an acute inflammatory response triggered by surgical trauma. Nonsteroidal anti-inflammatory drugs (NSAIDs), particularly Ibuprofen, are widely prescribed for symptom control but are often associated with gastrointestinal, renal, and cardiovascular adverse effects. Hence, safer alternatives with comparable efficacy are being investigated.
Aescin, a natural saponin derived from Aesculus hippocastanum (horse chestnut), exhibits anti-inflammatory, anti-edematous, and venotonic properties. It acts by stabilizing capillary membranes, reducing vascular permeability, and inhibiting the release of inflammatory mediators such as histamine and prostaglandins. Reparil tablets containing Aescin have been clinically validated for treating soft tissue edema and chronic venous insufficiency but have not been extensively evaluated in oral surgical applications.
This prospective, single-center, randomized, single-blind controlled trial will compare the postoperative efficacy of Aescin (Reparil) versus Ibuprofen in patients undergoing surgical extraction of impacted mandibular third molars. Participants will be randomly assigned (1:1) into two treatment groups using computer-generated allocation with pharmacist-controlled concealment. Both the operator and the outcome assessor will be blinded to treatment allocation.
Pain intensity will be measured using a 10-point Visual Analog Scale (VAS). Facial swelling will be objectively assessed using a 3D facial scanner (Revopoint POP 3), and trismus will be measured as the maximum interincisal distance. Assessments will be performed at baseline, postoperative day 2, and day 7. A rescue analgesic (diclofenac sodium 50 mg) will be provided for uncontrolled pain.
All data will be recorded via EpiData version 4.6, with statistical analysis conducted using IBM SPSS Statistics version 30.0. The primary endpoint is postoperative pain reduction; secondary endpoints include facial edema, trismus improvement, and adverse drug effects. This study will contribute to evidence on the use of herbal-based anti-inflammatory agents as potential alternatives to conventional NSAIDs in oral surgery.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 100 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Oman Medical Speciality Board is the lead sponsor of 15 studies on the registry; 10 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 () with no significant systemic illness.
Willing to provide written and attend all follow-up visits (Day 2 and Day 7 post-surgery).
Exclusion Criteria:
Known allergies or to Aescin, Ibuprofen, rescue medications, or local anesthetics.
Pregnant or lactating women.
Patients with 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., , alcohol, or tobacco).
Surgical time exceeding 30 minutes or cases with intraoperative complications requiring non-study medications.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive Reparil®-Dragees tablets containing Aescin 20 mg, manufactured by Meda Pharmaceuticals (Germany), administered orally three times daily (TID) for five consecutive days following surgical extraction of an impacted mandibular third molar. A rescue analgesic (Diclofenac potassium 50 mg, Rapidus® by Tabuk Pharmaceutical Manufacturing Co., Saudi Arabia) will be provided if pain is uncontrolled. Clinical assessments will be performed at baseline (preoperatively), on postoperative day 2, and on day 7 for pain (VAS), facial swelling (3D scan), and mouth opening (digital caliper).
Drug: Escin
Participants will receive Ibuprofen tablets 400 mg, manufactured by Flamingo Pharmaceuticals Ltd. (India), administered orally three times daily (TID) for five consecutive days following surgical extraction of an impacted mandibular third molar. Clinical evaluations will be conducted at baseline, postoperative day 2, and day 7 to assess pain intensity (Visual Analog Scale), facial swelling (3D facial scan), and mouth opening (digital caliper).
Drug: Ibuprofen 400 mg
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.
Also known as: Reparil®-Dragees
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.
Also known as: Ibuprofen 400 mg Tablets BP
Postoperative pain intensity
Change in pain intensity measured using a 10-point Visual Analog Scale (VAS) at baseline (preoperative), postoperative day 2, and postoperative day 7 following surgical extraction of impacted mandibular third molars.
Time frame: Baseline, Day 2, and Day 7 post-surgery
Facial swelling (edema)
Change in postoperative facial volume measured using a 3D facial scanner (Revopoint POP 3). Measurements will be taken at baseline (preoperative), postoperative day 2, and postoperative day 7 to assess the degree of facial edema following impacted mandibular third molar surgery.
Time frame: Baseline, Day 2, and Day 7 post-surgery
Mouth opening (trismus)
Change in maximum interincisal distance (in millimeters) measured using a digital caliper at baseline (preoperative), postoperative day 2, and postoperative day 7 following surgical extraction of impacted mandibular third molars.
Time frame: Baseline, Day 2, and Day 7 post-surgery
Adverse effects
Any drug-related or postoperative adverse effects observed or reported by participants within the 7-day postoperative period will be recorded.
Time frame: Baseline to Day 7 post-surgery
Plan to share: No — Individual participant data (IPD) will not be shared because the study is a single-center academic clinical trial conducted within a limited institutional setting. Only aggregated and de-identified summary results will be published in peer-reviewed journals and presented at scientific meetings in accordance with institutional and ethical guidelines.
Started Jan 2026 (actual). Primary completion is estimated for Oct 2026, 9 months after the start.
Of 2,089 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 9 months is below that.
Counting every sponsor, half of 2,102 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 30, 2026: primary completion Jul 2026 → Oct 2026 and completion Sep 2026 → Nov 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Escin
Oman Medical Speciality Board