TrismusNCT07543146
Effectiveness of Serratiopeptidase After Mandibular Third Molar Surgery
A study testing Serratiopeptidase and Standard Postoperative Care in people with Trismus, run by Sharif Medical Research Center at 1 site in Pakistan.
Trial summary
This randomized controlled trial was conducted to compare the effect of serratiopeptidase versus no intervention on postoperative mouth opening, swelling, and trismus following surgical removal of mesioangular 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
- Trismus
- What is being tested?
- Serratiopeptidase and Standard Postoperative Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Jun 2025to 2 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 aged 18 to 40 years.
- Patients requiring surgical removal of a mesioangular impacted mandibular third molar.
- Patients who are systemically healthy (ASA I or II).
- Patients willing to participate and provide written informed consent.
- Patients who can comply with postoperative follow-up visits.
Who cannot join
- Patients with systemic diseases affecting healing (e.g., diabetes, immunocompromised state).
- Pregnant or lactating women.
- Patients with known allergy or hypersensitivity to serratiopeptidase.
- Patients on long-term anti-inflammatory or steroid medication.
- Presence of acute infection at the surgical site.
- Patients who have taken anti-inflammatory drugs within 48 hours before surgery.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Sharif medical and dental college, jati umra.
Lahore, Punjab Province
About this study
Official title: Efficacy of Serratiopeptidase After Surgical Removal of Mesioangular Mandibular Third Molars: A Randomized Controlled Trial
This randomized controlled trial was conducted to compare the effect of serratiopeptidase versus no intervention on postoperative mouth opening, swelling, and trismus following surgical removal of mesioangular mandibular third molars.
Read the detailed description
A total of 110 patients undergoing surgical extraction of mesioangular mandibular third molars were randomly assigned into two groups. Group A received serratiopeptidase postoperatively, while Group B received no enzyme therapy. Mouth opening was measured postoperatively and compared between the two groups to assess the effectiveness of serratiopeptidase in reducing trismus and postoperative swelling.
- Conditions
- Trismus
- Being tested
- Serratiopeptidase, Standard Postoperative Care
- Medical subject headings
- Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerratiopeptidaseDrug
Serratiopeptidase was administered postoperatively following surgical removal of a mesioangular mandibular third molar as an adjunct to standard postoperative care to reduce postoperative pain, swelling, and inflammation.
Standard Postoperative CareOther
Routine postoperative management following surgical removal of a mesioangular mandibular third molar without serratiopeptidase, including prescribed analgesics, antibiotics if indicated, and postoperative instructions.
| Study group | Role | What they receive |
|---|---|---|
| Serratiopeptidase Group | Experimental | Patients in this group received serratiopeptidase postoperatively after surgical removal of a mesioangular mandibular third molar in addition to standard postoperative care. Receives: Drug: Serratiopeptidase; Other: Standard Postoperative Care |
| Control Group | Active comparator | Patients in this group received standard postoperative care without the administration of serratiopeptidase following surgical removal of a mesioangular mandibular third molar. Receives: Drug: Serratiopeptidase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Facial Swelling
Change in facial swelling measured using standardized facial measurements between fixed anatomical landmarks following surgical removal of a mesioangular mandibular third molar, comparing the serratiopeptidase group and the control group.
Measured: Postoperative Day 1, Day 3, and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start6 Jun 2025
- Primary completion2 Sep 2025
- Study completion2 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TrismusStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharif Medical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543146
- Sponsor's protocol ID
- SMDC/SMRC/245-22
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Serratiopeptidase After Surgical Removal of Mesioangular Mandibular Third Molars: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07543146
- Acronym / sponsor ID
- SMDC/SMRC/245-22
- Conditions
- Trismus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Sharif Medical Research CenterUniversity, hospital or other
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- 2 Sep 2025 (actual)
- Study completion
- 2 Sep 2025 (actual)
- First posted
- 21 Apr 2026 (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 controlled trial was conducted to compare the effect of serratiopeptidase versus no intervention on postoperative mouth opening, swelling, and trismus following surgical removal of mesioangular mandibular third molars.
Detailed description
A total of 110 patients undergoing surgical extraction of mesioangular mandibular third molars were randomly assigned into two groups. Group A received serratiopeptidase postoperatively, while Group B received no enzyme therapy. Mouth opening was measured postoperatively and compared between the two groups to assess the effectiveness of serratiopeptidase in reducing trismus and postoperative swelling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serratiopeptidase Group | Experimental | Drug: Serratiopeptidase, Other: Standard Postoperative CarePatients in this group received serratiopeptidase postoperatively after surgical removal of a mesioangular mandibular third molar in addition to standard postoperative care. |
| Control Group | Active comparator | Drug: SerratiopeptidasePatients in this group received standard postoperative care without the administration of serratiopeptidase following surgical removal of a mesioangular mandibular third molar. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients aged 18 to 40 years.
- Patients requiring surgical removal of a mesioangular impacted mandibular third molar.
- Patients who are systemically healthy (ASA I or II).
- Patients willing to participate and provide written informed consent.
- Patients who can comply with postoperative follow-up visits.
Key exclusion criteria (6 listed)
- Patients with systemic diseases affecting healing (e.g., diabetes, immunocompromised state).
- Pregnant or lactating women.
- Patients with known allergy or hypersensitivity to serratiopeptidase.
- Patients on long-term anti-inflammatory or steroid medication.
- Presence of acute infection at the surgical site.
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 |
|---|---|---|
| SerratiopeptidaseSerratiopeptidase was administered postoperatively following surgical removal of a mesioangular mandibular third molar as an adjunct to standard postoperative care to reduce postoperative pain, swelling, and inflammation. | Drug | Control Group, Serratiopeptidase Group |
| Standard Postoperative CareRoutine postoperative management following surgical removal of a mesioangular mandibular third molar without serratiopeptidase, including prescribed analgesics, antibiotics if indicated, and postoperative instructions. | Other | Serratiopeptidase Group |
Primary outcome
Postoperative Facial Swelling
Time frame: Postoperative Day 1, Day 3, and Day 7
Change in facial swelling measured using standardized facial measurements between fixed anatomical landmarks following surgical removal of a mesioangular mandibular third molar, comparing the serratiopeptidase group and the control group.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
Related trials for Trismus
Not yet recruiting
Autologous PRP Versus Triamcinolone Acetate in Patients With Oral Submucous Fibrosis
Oral Submucous Fibrosis
Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
Recruiting
Swallowing Rehabilitation Program for Head and Neck Tumor Patients
Head and Neck Cancer (H&N)
RecruitingPhase 2
Web-Based Program in Helping Patients With Head and Neck Cancer Adhere to Swallowing Exercises and Coping Strategies
Throat Carcinoma
Recruiting
Feasibility of Prospective Surveillance and Early Physical Therapy for Trismus
Head and Neck Cancer, Trismus
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serratiopeptidase and Standard Postoperative Care in people with Trismus, run by Sharif Medical Research Center at 1 site in Pakistan.
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: finished, as of the sponsor's last update on 21 Apr 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Facial Swelling (time frame: Postoperative Day 1, Day 3, and Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2026.