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Completed

NCT Number: NCT07543146

Effectiveness of Serratiopeptidase After Mandibular Third Molar Surgery

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.

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Key information

Conditions

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

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sharif medical and dental college, jati umra.

Lahore, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Sharif Medical Research Center

Other

Registry information

Official study title

Efficacy of Serratiopeptidase After Surgical Removal of Mesioangular Mandibular Third Molars: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 21, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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