Postoperative PainReparilNCT07244029
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
A study testing Escin and Ibuprofen 400 mg in people with Postoperative Pain and Facial Swelling, run by Oman Medical Speciality Board at 1 site in Oman.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Facial Swelling, Trismus
- What is being tested?
- Escin and Ibuprofen 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteOman
- Study dates
- 1 Jan 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Oman1 site, 1 recruiting
- Recruiting
Medical City for Military and Security Services - Dental Center
Muscat, Al Khoud, 111
Suhail H AlSamari, BDS, MFD, +968 97366511, suhail.dental@gmail.com
Vidya Shetty, BDS, MDS, +968 93681986, shettyvidya007@gmail.com
About this study
Official title: Evaluation of Aescin-Based Herbal Extracts for Managing Postoperative Sequelae Following Impacted Mandibular Third Molar Surgery: A Randomized, Single-Blind, Controlled 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.
Read the 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 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.
- Conditions
- Postoperative Pain, Facial Swelling, Trismus
- Being tested
- Escin, Ibuprofen 400 mg
- Keywords
- Aescin, Escin, Reparil, Ibuprofen, Herbal anti-inflammatory, Postoperative sequelae, Third molar extraction, Oral surgery, Phytotherapeutic agents, Pain management
- Medical subject headings
- Pain, Postoperative, Trismus, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscinDrug
Also called Reparil®-Dragees
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 mgDrug
Also called Ibuprofen 400 mg Tablets BP
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.
| Study group | Role | What they receive |
|---|---|---|
| Aescin (Reparil®) Group | Experimental | 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). Receives: Drug: Escin |
| Ibuprofen Group | Active comparator | 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). Receives: Drug: Ibuprofen 400 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Day 2, and Day 7 post-surgery
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline to Day 7 post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Jan 2026
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, parallel-group, randomized, single-blind controlled clinical trial comparing Reparil (Aescin 20 mg TID) versus Ibuprofen 400 mg TID following surgical extraction of impacted mandibular third molars.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oman Medical Speciality Board
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Suhail AlSamari, Oman Medical Speciality Board
- Investigators
- Suhail H AL Samari, BDS, MFD, Principal investigator, Oman Medical Speciality Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07244029
- Sponsor's protocol ID
- MCMSS-MREC 030/2025
- Acronym
- Reparil
- Status last verified
- Jan 2026
- First submitted
- 17 Nov 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Bjornsson GA, Haanaes HR, Skoglund LA. Ketoprofen 75 mg qid versus acetaminophen 1000 mg qid for 3 days on swelling, pain, and other postoperative events after third-molar surgery. J Clin Pharmacol. 2003 Mar;43(3):305-14. doi: 10.1177/0091270002250603.
PubMed 12638400Al-Khateeb TH, Nusair Y. Effect of the proteolytic enzyme serrapeptase on swelling, pain and trismus after surgical extraction of mandibular third molars. Int J Oral Maxillofac Surg. 2008 Mar;37(3):264-8. doi: 10.1016/j.ijom.2007.11.011. Epub 2008 Feb 12.
PubMed 18272344Lokken P, Olsen I, Bruaset I, Norman-Pedersen K. Bilateral surgical removal of impacted lower third molar teeth as a model for drug evaluation: a test with ibuprofen. Eur J Clin Pharmacol. 1975 Apr 4;8(3-4):209-16. doi: 10.1007/BF00567117.
PubMed 786680Yamashita Y, Sano N, Shimohira D, Danjo A, Goto M. A parallel-group comparison study of celecoxib with loxoprofen sodium in third mandibular molar extraction patients. Int J Oral Maxillofac Surg. 2014 Dec;43(12):1509-13. doi: 10.1016/j.ijom.2014.09.002. Epub 2014 Sep 28.
PubMed 25270186Olmedo MV, Galvez R, Vallecillo M. Double-blind parallel comparison of multiple doses of ketorolac, ketoprofen and placebo administered orally to patients with postoperative dental pain. Pain. 2001 Feb 1;90(1-2):135-41. doi: 10.1016/s0304-3959(00)00396-1.
PubMed 11166979Wang D, He X, Wang Y, Li Z, Zhu Y, Sun C, Ye J, Jiang H, Cheng J. External root resorption of the second molar associated with mesially and horizontally impacted mandibular third molar: evidence from cone beam computed tomography. Clin Oral Investig. 2017 May;21(4):1335-1342. doi: 10.1007/s00784-016-1888-y. Epub 2016 Jun 18.
PubMed 27316639Ong CK, Lirk P, Tan JM, Sow BW. The analgesic efficacy of intravenous versus oral tramadol for preventing postoperative pain after third molar surgery. J Oral Maxillofac Surg. 2005 Aug;63(8):1162-8. doi: 10.1016/j.joms.2005.04.028.
PubMed 16094585Majid OW, Al-Mashhadani BA. Perioperative bromelain reduces pain and swelling and improves quality of life measures after mandibular third molar surgery: a randomized, double-blind, placebo-controlled clinical trial. J Oral Maxillofac Surg. 2014 Jun;72(6):1043-8. doi: 10.1016/j.joms.2013.12.035. Epub 2014 Jan 16.
PubMed 24589242Gaspani L, Limiroli E, Ferrario P, Bianchi M. In vivo and in vitro effects of bromelain on PGE(2) and SP concentrations in the inflammatory exudate in rats. Pharmacology. 2002 May;65(2):83-6. doi: 10.1159/000056191.
PubMed 11937778Bataineh AB, Batarseh RA. The effect of modified surgical flap design for removal of lower third molars on lingual nerve injury. Clin Oral Investig. 2017 Jul;21(6):2091-2099. doi: 10.1007/s00784-016-1999-5. Epub 2016 Nov 12.
PubMed 27837346Graziani F, D'Aiuto F, Gennai S, Petrini M, Nisi M, Cirigliano N, Landini L, Bruno RM, Taddei S, Ghiadoni L. Systemic Inflammation after Third Molar Removal: A Case-Control Study. J Dent Res. 2017 Dec;96(13):1505-1512. doi: 10.1177/0022034517722775. Epub 2017 Jul 31.
PubMed 28759304Mehra P, Reebye U, Nadershah M, Cottrell D. Efficacy of anti-inflammatory drugs in third molar surgery: a randomized clinical trial. Int J Oral Maxillofac Surg. 2013 Jul;42(7):835-42. doi: 10.1016/j.ijom.2013.02.017. Epub 2013 Mar 25.
PubMed 23535007Gallelli L. Escin: a review of its anti-edematous, anti-inflammatory, and venotonic properties. Drug Des Devel Ther. 2019 Sep 27;13:3425-3437. doi: 10.2147/DDDT.S207720. eCollection 2019.
PubMed 31631970Piecuch JF. What strategies are helpful in the operative management of third molars? J Oral Maxillofac Surg. 2012 Sep;70(9 Suppl 1):S25-32. doi: 10.1016/j.joms.2012.04.027.
PubMed 22916697Singhai A, Kambala R, Bhola N. Comparison of the efficacy of aescin and diclofenac sodium in the management of postoperative sequelae and their effect on salivary Prostaglandin E2 and serum C-reactive protein levels after surgical removal of impacted mandibular third molar: a randomized, double-blind, controlled clinical trial. F1000Res. 2024 Oct 30;13:106. doi: 10.12688/f1000research.145643.3. eCollection 2024.
PubMed 39507581
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Aescin-Based Herbal Extracts for Managing Postoperative Sequelae Following Impacted Mandibular Third Molar Surgery: A Randomized, Single-Blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT07244029
- Acronym / sponsor ID
- Reparil / MCMSS-MREC 030/2025
- Conditions
- Postoperative Pain, Facial Swelling, Trismus
- Keywords
- Aescin, Escin, Reparil, Ibuprofen, Herbal anti-inflammatory, Postoperative sequelae, Third molar extraction, Oral surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Oman Medical Speciality BoardOther government
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group, randomized, single-blind controlled clinical trial comparing Reparil (Aescin 20 mg TID) versus Ibuprofen 400 mg TID following surgical extraction of impacted mandibular third molars.
| Arm | Type | Receives |
|---|---|---|
| Aescin (Reparil®) Group | Experimental | Drug: EscinParticipants 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). |
| Ibuprofen Group | Active comparator | Drug: Ibuprofen 400 mgParticipants 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). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EscinAlso: Reparil®-DrageesOral 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. | Drug | Aescin (Reparil®) Group |
| Ibuprofen 400 mgAlso: Ibuprofen 400 mg Tablets BPOral 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. | Drug | Ibuprofen Group |
Primary outcome
Postoperative pain intensity
Time frame: Baseline, Day 2, and Day 7 post-surgery
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.
3 secondary outcomes
Facial swelling (edema)
Time frame: Baseline, Day 2, and Day 7 post-surgery
Mouth opening (trismus)
Time frame: Baseline, Day 2, and Day 7 post-surgery
Adverse effects
Time frame: Baseline to Day 7 post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Background: PubMed 12638400Bjornsson GA, Haanaes HR, Skoglund LA. Ketoprofen 75 mg qid versus acetaminophen 1000 mg qid for 3 days on swelling, pain, and other postoperative events after third-molar surgery. J Clin Pharmacol. 2003 Mar;43(3):305-14. doi: 10.1177/0091270002250603.
- Background: PubMed 18272344Al-Khateeb TH, Nusair Y. Effect of the proteolytic enzyme serrapeptase on swelling, pain and trismus after surgical extraction of mandibular third molars. Int J Oral Maxillofac Surg. 2008 Mar;37(3):264-8. doi: 10.1016/j.ijom.2007.11.011. Epub 2008 Feb 12.
- Background: PubMed 786680Lokken P, Olsen I, Bruaset I, Norman-Pedersen K. Bilateral surgical removal of impacted lower third molar teeth as a model for drug evaluation: a test with ibuprofen. Eur J Clin Pharmacol. 1975 Apr 4;8(3-4):209-16. doi: 10.1007/BF00567117.
- Background: PubMed 25270186Yamashita Y, Sano N, Shimohira D, Danjo A, Goto M. A parallel-group comparison study of celecoxib with loxoprofen sodium in third mandibular molar extraction patients. Int J Oral Maxillofac Surg. 2014 Dec;43(12):1509-13. doi: 10.1016/j.ijom.2014.09.002. Epub 2014 Sep 28.
- Background: PubMed 11166979Olmedo MV, Galvez R, Vallecillo M. Double-blind parallel comparison of multiple doses of ketorolac, ketoprofen and placebo administered orally to patients with postoperative dental pain. Pain. 2001 Feb 1;90(1-2):135-41. doi: 10.1016/s0304-3959(00)00396-1.
- Background: PubMed 27316639Wang D, He X, Wang Y, Li Z, Zhu Y, Sun C, Ye J, Jiang H, Cheng J. External root resorption of the second molar associated with mesially and horizontally impacted mandibular third molar: evidence from cone beam computed tomography. Clin Oral Investig. 2017 May;21(4):1335-1342. doi: 10.1007/s00784-016-1888-y. Epub 2016 Jun 18.
- Background: PubMed 16094585Ong CK, Lirk P, Tan JM, Sow BW. The analgesic efficacy of intravenous versus oral tramadol for preventing postoperative pain after third molar surgery. J Oral Maxillofac Surg. 2005 Aug;63(8):1162-8. doi: 10.1016/j.joms.2005.04.028.
- Background: PubMed 24589242Majid OW, Al-Mashhadani BA. Perioperative bromelain reduces pain and swelling and improves quality of life measures after mandibular third molar surgery: a randomized, double-blind, placebo-controlled clinical trial. J Oral Maxillofac Surg. 2014 Jun;72(6):1043-8. doi: 10.1016/j.joms.2013.12.035. Epub 2014 Jan 16.
- Background: PubMed 11937778Gaspani L, Limiroli E, Ferrario P, Bianchi M. In vivo and in vitro effects of bromelain on PGE(2) and SP concentrations in the inflammatory exudate in rats. Pharmacology. 2002 May;65(2):83-6. doi: 10.1159/000056191.
- Background: PubMed 27837346Bataineh AB, Batarseh RA. The effect of modified surgical flap design for removal of lower third molars on lingual nerve injury. Clin Oral Investig. 2017 Jul;21(6):2091-2099. doi: 10.1007/s00784-016-1999-5. Epub 2016 Nov 12.
- Background: PubMed 28759304Graziani F, D'Aiuto F, Gennai S, Petrini M, Nisi M, Cirigliano N, Landini L, Bruno RM, Taddei S, Ghiadoni L. Systemic Inflammation after Third Molar Removal: A Case-Control Study. J Dent Res. 2017 Dec;96(13):1505-1512. doi: 10.1177/0022034517722775. Epub 2017 Jul 31.
- Background: PubMed 23535007Mehra P, Reebye U, Nadershah M, Cottrell D. Efficacy of anti-inflammatory drugs in third molar surgery: a randomized clinical trial. Int J Oral Maxillofac Surg. 2013 Jul;42(7):835-42. doi: 10.1016/j.ijom.2013.02.017. Epub 2013 Mar 25.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suhail H AL Samari, BDS, MFD principal investigator
Oman Medical Speciality Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Escin and Ibuprofen 400 mg in people with Postoperative Pain and Facial Swelling, run by Oman Medical Speciality Board at 1 site in Oman.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Oman. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suhail H AlSamari, BDS, MFD (+968 97366511, suhail.dental@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain intensity (time frame: Baseline, Day 2, and Day 7 post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07244029, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.