Health Trials

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

ConditionsPostoperative PainFacial SwellingTrismus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorOman Medical Speciality Board

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Patients indicated for surgical removal of impacted mandibular third molars according to National Institute for Health and Care Excellence (NICE) guidelines.

Disqualifiers

Recent use (within three weeks preoperatively) of anti-inflammatories, corticosteroids, or antibiotics.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Escin

    Drug

    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.

  • Ibuprofen 400 mg

    Drug

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Aescin (Reparil®) GroupExperimental treatment 1 intervention
Group B: Ibuprofen GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oman Medical Speciality Board

Lead sponsor

Source ClinicalTrials.gov
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