A comparison of recovery after impacted wisdom tooth removal
| ISRCTN | ISRCTN15432618 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15432618 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | University of Science and Technology, Sana’a |
| Funder | Investigator initiated and funded |
- Submission date
- 01/11/2025
- Registration date
- 11/11/2025
- Last edited
- 11/11/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
The surgical removal of impacted wisdom teeth (third molars) is one of the most common procedures in oral surgery. However, patients often experience swelling (facial edema), limited mouth opening (trismus), and pain after the operation. These symptoms are usually managed with anti-inflammatory medications such as corticosteroids and nonsteroidal anti-inflammatory drugs (NSAIDs). While effective, these drugs can sometimes cause side effects, including stomach problems and kidney issues. This study aims to compare two alternative natural treatments, serratiopeptidase (an enzyme) and escin (a plant extract from horse chestnut), to see which is more effective in reducing swelling, pain, and trismus after wisdom tooth surgery when used together with standard medications.
Who can participate?
Adults who are medically healthy and have two lower wisdom teeth (third molars) that need surgical removal can participate.
What does the study involve?
This study uses a split-mouth design, meaning each participant acts as their own control. The two wisdom teeth will be removed in two separate surgeries, about three weeks apart.
• In one surgery, the participant will receive standard medications only (antibiotic, painkiller, and anti-inflammatory).
• In the other surgery, they will receive standard medications plus either serratiopeptidase or escin for five days after surgery.
The order and side (right or left) will be chosen randomly.
Measurements of mouth opening, facial swelling, and pain will be taken before surgery and on the 2nd, 3rd, and 5th days after each procedure.
What are the possible benefits and risks of participating?
All treatments used are known to be safe and well-tolerated when taken as directed. Participation will also contribute to improving clinical knowledge on safer alternatives for managing postoperative symptoms after wisdom tooth removal.
Participants may experience reduced swelling, pain, and discomfort following surgery, depending on the effectiveness of the treatment. The risks are minimal and mainly related to normal postoperative effects such as mild pain or swelling.
Where is the study run from?
The study is being conducted at the dental clinics of the College of Dentistry, University of Science and Technology, Sana’a, Yemen.
When is the study starting and how long is it expected to run for?
November 2023 to January 2025. The study began recruiting in July 2024 and was expected to run for approximately one year, including recruitment, follow-up, and data analysis.
Who is funding the study?
The research is self-funded by the investigator with institutional support from the University of Science and Technology, Yemen.
Who is the main contact?
Dr Arwa Mohammed Hussien Dahak (Principal Investigator), hamddahak@gmail.com, info@ust.edu.ye
Contact information
Public, Scientific, Principal investigator
University of Science and Technology
Madhbah Roundabout, 60 Street
Sana'a
00000
Yemen
| Phone | +967 (1) 373237 |
|---|---|
| hamddahak@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Split-mouth interventional triple-blind randomized controlled clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Comparison of efficacy of serratiopeptidase and escin after impacted mandibular third molar surgery: a randomized controlled clinical trial |
| Study acronym | CESE-3M |
| Study objectives | 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: 1. To evaluate the efficacy of serratiopeptidase, as an adjunct to conventional drugs, in reducing postoperative complications (i.e., trismus, facial edema, and pain) following impacted mandibular third molar surgery. 2. To evaluate the efficacy of escin, as an adjunct to conventional drugs in reducing postoperative complications (i.e., trismus, facial edema, and pain) following impacted mandibular third molar surgery. |
| Ethics approval(s) |
Approved 30/07/2024, University Research Ethics Committee (60th Street, Madhbah Roundabout, Sana'a, 00000, Yemen; +967 (1) 373237; info@ust.edu.ye), ref: 1445/0012/UREC/UST |
| Health condition(s) or problem(s) studied | Postoperative complications—trismus, facial edema (swelling), and pain—in patients undergoing impacted mandibular third molar (wisdom tooth) extraction. |
| Intervention | This is a triple-blind, split-mouth randomized controlled clinical trial. Each participant undergoes two separate impacted mandibular third molar extractions (one per side) and thus serves as their own control. On the first surgical visit, one side is treated with conventional postoperative medications plus an adjunct (either serratiopeptidase or escin), and after a three-week washout, the contralateral molar is extracted and treated with conventional medications alone, or vice versa. Participants are randomly assigned using sealed envelopes to determine which side and which treatment order they receive. The interventions are: • Experimental 1: Conventional medications plus oral serratiopeptidase 10 mg, administered immediately postoperatively and then three times daily for five days. • Experimental 2: Conventional medications plus oral escin 20 mg, administered immediately postoperatively and then three times daily for five days. • Control: Conventional medications alone (no enzyme/herbal adjunct). Conventional medications given to all participants are Amoxicillin 500 mg twice daily, Metronidazole 500 mg three times daily, and Diclofenac sodium 50 mg twice daily as per the trial protocol. Blinding and allocation: the study is triple-blind (patients, the evaluator, and the person analyzing outcomes are blinded; the operator performs surgery but is blind to evaluation data). Treatments are randomly allocated to sides/orders so that bias is minimized. Outcome measures include postoperative trismus, facial edema (swelling), and pain assessed at prespecified timepoints. 1. 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) 2. 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 3. 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. |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Serratiopeptidase, Serrapeptase, Escin, Aescine (OS: DCF), Sodium aescinate (IS) |
| Primary outcome measure(s) |
The following primary outcome measures were assessed before and after the surgical procedure: |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 05/01/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | All |
| Target sample size at registration | 31 |
| Total final enrolment | 24 |
| Key inclusion criteria | 1. Medically healthy 2. Presence of two mandibular third molars indicated for surgical extraction 3. No history of pericoronitis or other signs of inflammation within the past 30 days |
| Key exclusion criteria | 1. Current use of other medications such as NSAIDs or corticosteroids 2. Known allergy to any drugs administered in this study 3. Pregnancy or breastfeeding 4. History of diabetes or hypertension 5. Previous irradiation to the maxillofacial region 6. Intellectual disability or inability to attend follow-up visits 7. Presence of acute or subacute pericoronitis |
| Date of first enrolment | 30/07/2024 |
| Date of final enrolment | 05/01/2025 |
Locations
Countries of recruitment
- Yemen
Study participating centre
Sana'a
00000
Yemen
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study are not expected to be made available due to confidentiality concerns and institutional data protection policies of the University of Science and Technology, Yemen. The collected data contain identifiable clinical information that cannot be anonymized without risking patient privacy. However, summarized or aggregated data supporting the findings of this study may be made available from the corresponding author upon reasonable request and with approval from the institutional ethics committee. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
03/11/2025: Study's existence confirmed by the Republic of Yemen, University of Science & Technology, Faculty of Medicine & Health Sciences, Research Ethics Committee.
