Effectiveness of Serratiopeptidase After Mandibular Third Molar Surgery

NCT07543146 | Completed

• 1 other identifier: SMDC/SMRC/245-22
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Trismus

Outcome Measures

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.

  Postoperative Day 1, Day 3, and Day 7

Study Arms (2)

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.

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.

Drug: Serratiopeptidase

Interventions

Serratiopeptidase DRUG

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.

Control Group; Serratiopeptidase Group

Standard Postoperative Care OTHER

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

Serratiopeptidase Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sharif Medical Research Center: lead

Study Sites (1)

Sharif medical and dental college, jati umra.

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Trismus

Interventions

serratiopeptidase

Condition Hierarchy (Ancestors)

Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start: June 6, 2025
• Primary Completion: September 2, 2025
• Study Completion: September 2, 2025
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

PA (1)