Study of Trinase to Reduce Pain After Root Canal Treatment in Men Aged 18 to 50 With Symptomatic Irreversible Pulpitis

What this Trial Is About

This research aims to evaluate whether Trinase, an enzyme-based anti-inflammatory medication containing trypsin, bromelain, and rutin, can reduce pain after root canal treatment in male patients diagnosed with symptomatic irreversible pulpitis. The study focuses on 182 healthy male adults aged 18 to 50 years who experience moderate to severe tooth pain. It is designed as a randomized, double-blind, placebo-controlled clinical trial to assess post-operative pain relief and analgesic use following treatment. Participants are randomly assigned to receive either a single oral Trinase tablet or a matching placebo 30 minutes before undergoing a standard single-visit root canal treatment. The procedure involves local anesthesia, rubber dam isolation, mechanical canal cleaning with rotary instruments, irrigation, and canal obturation using a modified technique. All treatments are performed by the same experienced operator to ensure consistency. Both groups follow the same clinical protocol, with only the premedication differing. Patients will record pain intensity on a Visual Analogue Scale VAS at baseline and then at 6, 12, 24, and 48 hours after root canal treatment. They will also document the number of pain-relief tablets taken during this 48-hour period. The study will analyze differences in pain scores and analgesic consumption between the Trinase and placebo groups. The total active participation duration for each participant is about 48 hours post-treatment, with no additional invasive procedures beyond standard care.

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.