A Randomized Controlled Trial Evaluating Whether Pre-operative Trinase Reduces Post-operative Pain in Patients With Symptomatic Irreversible Pulpitis Compared to Placebo, Using VAS Scores and Analgesic Intake Over 48 Hours.

This study aims to determine whether Trinase, an enzyme-based anti-inflammatory medication, can reduce pain after root canal treatment in patients with symptomatic irreversible pulpitis. A total of 182 male patients aged 18 to 50 years who present with moderate to severe tooth pain will be randomly assigned to receive either a Trinase tablet or a placebo 30 minutes before treatment. All root canal procedures will be performed in a single visit using standard endodontic techniques. Pain levels will be measured on a Visual Analogue Scale (VAS) before treatment and at 6, 12, 24, and 48 hours after treatment. Patients will also record the number of pain-relief tablets they take during the first 48 hours. The goal of the study is to see whether Trinase can lower post-operative pain and reduce the need for analgesic medication compared with placebo. This information may help improve pain management for patients undergoing root canal therapy.

NCT Number	NCT07239505
Lead Sponsor	Fayoum University
Conditions	Symptomatic Irreversible Pulpitis (SIP), Postoperative Pain After Endodontic Treatment, Endodontic Disease, Dental Pain
Enrollment	182 participants
Start Date	2025-08-01
Primary Completion	2025-12-15 (estimated)
Study Completion	2025-12-15 (estimated)
Updated on ClinicalTrials.gov	2025-12-01