Effectiveness of Serratiopeptidase After Mandibular Third Molar Surgery

April 14, 2026 updated by: Sharif Medical Research Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

- 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
Other: Standard 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.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Postoperative Day 1, Day 3, and Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sharif Medical Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2025

Primary Completion (Actual)

September 2, 2025

Study Completion (Actual)

September 2, 2025

Study Registration Dates

First Submitted

April 14, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMDC/SMRC/245-22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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