A Phase 3 interventional study of serratiopeptidase and Escin in Impacted Mandibular Third Molar Extraction and Post Operative Complications, sponsored by University of Science and Technology, Yemen. Completed at 1 site in Yemen. Per ClinicalTrials.gov, last updated 2025-12-26.
Sponsored by University of Science and Technology, Yemen · Phase 3, Interventional, and Treatment
Justification of the Study There is a high prevalence of impacted third molars, often accompanied by a range of postoperative complications. To the best of the researcher's knowledge, no clinical study to date has directly compared the efficacy of serratiopeptidase and escin in minimizing the most commonly observed postoperative complications following impacted mandibular third molar surgery. This study seeks to address this gap by providing empirical evidence that could contribute to optimizing postoperative care.
Objectives of the Study
Drawing from the background and research questions outlined above, the objectives of this study are divided into general and specific ones, outlined as follows:
General Objective To compare the efficacy of serratiopeptidase and escin, when used as adjuncts to conventional drugs, in reducing postoperative complications (i.e., trismus, facial edema, and pain) following impacted mandibular third molar surgery.
Specific Objectives
The study set the following specific objectives:
Study Hypotheses The study formulated the following hypotheses
This clinical trial employed a split-mouth design, wherein two different treatments were randomly assigned to opposite halves of each patient's mouth. The study was conducted as a triple-blind randomized trial to minimize bias and enhance scientific rigor. The procedures were carried out by the researcher; however, the operator was blinded to the evaluation data. The evaluator, who had access to patients' symptom responses, remained unaware of which treatment was administered on each side. Likewise, patients were blinded to the treatment or intervention applied to each side of their mouth.
Participants were allocated into two groups, with each patient serving as their own control through the split-mouth approach. On one side, an impacted mandibular third molar was extracted and treated with conventional medications. After a washout period of three weeks, the contralateral molar was extracted and treated with an additional intervention alongside the conventional drugs-either an enzyme or a herbal agent. The groups were defined as follows:
The conventional medication administered to both groups consisted of Amoxicillin 500 mg capsules twice daily, Metronidazole 500 mg tablets three times daily, and Diclofenac sodium 50 mg tablets twice daily.
107 studies on the registry are indexed under Trismus; 19 are open to participants now.
This study's enrollment of 24 is below the median of 52 across 99 interventional studies indexed under Trismus.
Browse Trismus studies →University of Science and Technology, Yemen is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
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.
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.
This group received conventional medications combined with 10 mg oral serratiopeptidase, administered immediately postoperatively and then thrice daily for five days following the first surgical visit.
Drug: serratiopeptidase
During the second visit (after three weeks), only conventional drugs were given. It was consisted of Amoxicillin 500 mg capsules twice daily, Metronidazole 500 mg tablets three times daily, and Diclofenac sodium 50 mg tablets twice daily.
Drug: Conventional drugs
This group received conventional medications combined with 20 mg oral escin, administered immediately postoperatively and then thrice daily for five days following the first surgical visit
Drug: Escin
During the second visit (after three weeks), only conventional drugs were given. It was consisted of Amoxicillin 500 mg capsules twice daily, Metronidazole 500 mg tablets three times daily, and Diclofenac sodium 50 mg tablets twice daily.
Drug: Conventional drugs
10 mg oral serratiopeptidase , Amoxicillin 500 mg, Metronidazole 500 mg, Diclofenac sodium 50 mg
Also known as: Amoxicillin, Metronidazole, and Diclofenac sodium
20 mg oral escin , Amoxicillin 500 mg, Metronidazole 500 mg, Diclofenac sodium 50 mg
Also known as: Amoxicillin, Metronidazole, and Diclofenac sodium
Amoxicillin 500 mg, Metronidazole 500 mg, Diclofenac sodium 50 mg
Also known as: Amoxicillin, Metronidazole, and Diclofenac sodium
Facial Edema
Facial edema was assessed using the method described by Schultze-Mosgau et al. (1995) to quantitatively evaluate edema both before and after surgery. Measurements were taken with a flexible measuring scale while the patient maintained a closed-mouth position. Five fixed anatomical landmarks and three baseline reference lines were used for consistency: • Fixed points: F1 - Tragus of the ear F2 - Angle of the mandible F3 - Soft tissue pogonion F4 - Corner of the mouth F5 - Lateral canthus of the eye • Baseline reference lines: S1 - From tragus of the ear to corner of the mouth (Tr-Com) S2 - From tragus of the ear to soft tissue pogonion (Tr-Pgo) S3 - From lateral canthus of the eye to angle of the mandible (Lc-Gn)
Time frame: Baseline measurements were recorded preoperatively. Measurements were reassessed at specific post-operative intervals: immediately after surgery and on the 2nd, 3rd, and 5th postoperative days.
Trismus
Trismus was evaluated by measuring the change in maximum mouth opening before and after the surgical procedure. Using a calibrated ruler, the distance between the incisal edges of the upper and lower central incisors was measured in millimeters
Time frame: Baseline measurements were recorded preoperatively. Measurements were reassessed at specific post-operative intervals: immediately after surgery and on the 2nd, 3rd, and 5th postoperative days.
Pain Intensity
Pain intensity was evaluated both pre-operatively and post-operatively using a standardized 10-centimeter visual analogue scale (VAS), as described by Sirintawat et al. (2017). The scale ranged from 0, representing no pain, to 10, indicating the worst imaginable pain. At each assessment interval, patients reported the degree of pain they experienced on the scale, providing a simple yet reliable measure of subjective pain.
Time frame: Baseline measurements were recorded preoperatively. Measurements were reassessed at specific post-operative intervals: immediately after surgery and on the 2nd, 3rd, and 5th postoperative days.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2023 to primary completion in Jan 2025, 13 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Escin
University of Science and Technology, Yemen