Ketoprofen 75 mg qid versus acetaminophen 1000 mg qid for 3 days on swelling, pain, and other postoperative events after third-molar surgery.
G A Bjørnsson, H R Haanaes, L A Skoglund
https://pubmed.ncbi.nlm.nih.gov/12638400Actively Recruiting
Phase Not Applicable
Age: 18Years - 40Years
All Genders
Healthy Volunteers
ID07244029
Evaluation of Aescin-Based Herbal Extracts for Managing Postoperative Sequelae Following Impacted Mandibular Third Molar Surgery: A Randomized, Single-Blind, Controlled Trial
Led by Oman Medical Speciality Board · Updated on 2026-01-15
100
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates the effects of an Aescin-based herbal extract called Reparil compared with Ibuprofen in managing symptoms after surgical removal of impacted lower wisdom teeth. The study focuses on people aged 18 to 40 who undergo this common oral surgery, aiming to find out if the herbal treatment offers pain relief and reduces swelling and limited mouth opening with fewer side effects than traditional nonsteroidal anti-inflammatory drugs (NSAIDs). Participants will be randomly assigned to receive either Reparil tablets containing 20 mg Aescin or 400 mg Ibuprofen tablets, each taken orally three times a day for five days after surgery. Both groups follow the same schedule, and a rescue pain medication is available if needed. Assessments will occur before surgery and on days 2 and 7 afterward to measure pain, facial swelling using 3D scanning, and mouth opening using a digital caliper. During the study, participants will have their pain levels, facial swelling, and jaw movement tracked at specific intervals. Researchers will record any adverse effects and analyze data to compare the treatments' impacts. The total involvement includes the surgery and follow-up visits on days 2 and 7, helping to evaluate the herbal extract as a potential alternative to Ibuprofen for managing post-surgical symptoms.
CONDITIONS
Brief Title
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Who Can Participate
Age: 18Years - 40Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Patients indicated for surgical removal of impacted mandibular third molars according to 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 classified as ASA I-II with no significant systemic illness
- Willing to provide written informed consent and attend all follow-up visits on Day 2 and Day 7 post-surgery
You will not qualify if you...
- 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 such as 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, including contraceptives, alcohol, or tobacco
- Surgical time exceeding 30 minutes or cases with intraoperative complications requiring non-study medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 5 days
Participants undergo surgical extraction of an impacted mandibular third molar and receive either Aescin or Ibuprofen orally three times daily for five consecutive days to manage postoperative pain, swelling, and trismus.
1 baseline visit (preoperative) and 2 postoperative visits on Day 2 and Day 7
Follow-up
Duration - Up to Day 7 post-surgery
Participants are assessed for postoperative pain, facial swelling, mouth opening, and any adverse effects up to 7 days after surgery.
Assessments occur during the postoperative Day 2 and Day 7 visits
Trial Site Locations
Total: 1 location
1
Medical City for Military and Security Services - Dental Center
Muscat, Al Khoud, Oman, 111
Actively Recruiting
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Research Team
S
Suhail H AlSamari, BDS, MFD
V
Vidya Shetty, BDS, MDS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Effect of the proteolytic enzyme serrapeptase on swelling, pain and trismus after surgical extraction of mandibular third molars.
T H Al-Khateeb, Y Nusair
https://pubmed.ncbi.nlm.nih.gov/18272344Bilateral surgical removal of impacted lower third molar teeth as a model for drug evaluation: a test with ibuprofen.
P Lökken, I Olsen, I Bruaset...
https://pubmed.ncbi.nlm.nih.gov/786680A parallel-group comparison study of celecoxib with loxoprofen sodium in third mandibular molar extraction patients.
Y Yamashita, N Sano, D Shimohira...
https://pubmed.ncbi.nlm.nih.gov/25270186Double-blind parallel comparison of multiple doses of ketorolac, ketoprofen and placebo administered orally to patients with postoperative dental pain.
M V Olmedo, R Gálvez, M Vallecillo
https://pubmed.ncbi.nlm.nih.gov/11166979External root resorption of the second molar associated with mesially and horizontally impacted mandibular third molar: evidence from cone beam computed tomography.
Dongmiao Wang, Xiaotong He, Yanling Wang...
https://pubmed.ncbi.nlm.nih.gov/27316639The analgesic efficacy of intravenous versus oral tramadol for preventing postoperative pain after third molar surgery.
Cliff K S Ong, Phillip Lirk, Juliana M H Tan...
https://pubmed.ncbi.nlm.nih.gov/16094585Perioperative bromelain reduces pain and swelling and improves quality of life measures after mandibular third molar surgery: a randomized, double-blind, placebo-controlled clinical trial.
Omer Waleed Majid, Bashar Adil Al-Mashhadani
https://pubmed.ncbi.nlm.nih.gov/24589242In vivo and in vitro effects of bromelain on PGE(2) and SP concentrations in the inflammatory exudate in rats.
Leda Gaspani, Elena Limiroli, Paolo Ferrario...
https://pubmed.ncbi.nlm.nih.gov/11937778The effect of modified surgical flap design for removal of lower third molars on lingual nerve injury.
Anwar B Bataineh, Ra'ad A Batarseh
https://pubmed.ncbi.nlm.nih.gov/27837346