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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.
Sponsor: Fayoum University
Summary
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.
Official title: The Role Of Trinase In Reducing Post-Operative Pain For Patients With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
Key Details
Gender
MALE
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
182
Start Date
2025-08-01
Completion Date
2025-12-15
Last Updated
2025-12-01
Healthy Volunteers
No
Conditions
Interventions
Trinase
One tablet of Trinase (proteolytic enzyme combination: trypsin, bromelain, and rutin) administered orally 30 minutes prior to root canal treatment. Used as premedication to reduce postoperative pain and inflammation.
placebo capsule
One identical-appearing placebo tablet administered orally 30 minutes prior to root canal treatment. Used as control.
Locations (1)
Fayoum University
Al Fayyum, Faiyum Governorate, Egypt