ClinicalTrials.gg
CompletedNCT07543146Updated Apr 21, 2026

Effectiveness of Serratiopeptidase After Mandibular Third Molar Surgery

An interventional study of Serratiopeptidase and Standard Postoperative Care in Trismus, sponsored by Sharif Medical Research Center. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-21.

Sponsored by Sharif Medical Research Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jun 2025, registered Apr 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Trismus

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03

In context

Trismus

107 studies on the registry are indexed under Trismus; 19 are open to participants now.

This study's enrollment of 110 is above the median of 52 across 99 interventional studies indexed under Trismus.

Browse Trismus studies →

Lead sponsor

Sharif Medical Research Center is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

- Patients aged 18 to 40 years.

Patients requiring surgical removal of a mesioangular impacted mandibular third molar.

Patients who are systemically healthy ().

Patients willing to participate and provide written .

Patients who can comply with postoperative follow-up visits.

Exclusion criteria

Exclusion Criteria:

  • Patients with systemic diseases affecting healing (e.g., diabetes, state).

Pregnant or lactating women.

Patients with known allergy or to serratiopeptidase.

Patients on long-term anti-inflammatory or medication.

Presence of acute infection at the surgical site.

Patients who have taken anti-inflammatory drugs within 48 hours before surgery.

Terms in these criteria, in plain language(5)

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.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
110 participants (actual)

Study arms

  • Experimental
    Serratiopeptidase Group

    Patients in this group received serratiopeptidase postoperatively after surgical removal of a mesioangular mandibular third molar in addition to standard postoperative care.

    Drug: Serratiopeptidase · Other: Standard Postoperative Care

  • Active comparator
    Control Group

    Patients in this group received standard postoperative care without the administration of serratiopeptidase following surgical removal of a mesioangular mandibular third molar.

    Drug: Serratiopeptidase

Interventions

  • DrugSerratiopeptidase

    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.

  • OtherStandard Postoperative Care

    Routine postoperative management following surgical removal of a mesioangular mandibular third molar without serratiopeptidase, including prescribed analgesics, antibiotics if indicated, and postoperative instructions.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Postoperative Day 1, Day 3, and Day 7

07

Study locations

1 site
  • Sharif medical and dental college, jati umra.
    Lahore, Punjab Province, Pakistan
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2025 to primary completion in Sep 2025, 2 months.

Of 57 non-industry interventional studies with no phase under Trismus, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 21. This study's 2 months is below that.

Counting every sponsor, half of 58 studies reached it within 8 months; a quarter within 4 and three quarters within 21.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 14, 2026
First posted
Apr 21, 2026
StartActual
Jun 6, 2025
Primary completionActual
Sep 2, 2025
CompletionActual
Sep 2, 2025
Last update
Apr 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07543146
Lead sponsor
Sharif Medical Research Center
Responsible party
Sponsor
First posted
Apr 21, 2026
Start date
Jun 6, 2025
Primary completion
Sep 2, 2025
Completion
Sep 2, 2025
Last update
Apr 21, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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