The Role Of Trinase In Reducing Post-Operative Pain For Patients With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial

Symptomatic irreversible pulpitis is a common endodontic condition characterized by severe inflammatory dental pain. Although root canal treatment (RCT) is effective in removing the inflamed pulp tissue, many patients continue to experience pain during the first 24-48 hours after treatment. Post-operative endodontic pain affects patient comfort, satisfaction, and clinical workflow, making pain control an essential component of evidence-based endodontic care.

Traditional pharmacological methods for managing post-operative dental pain include nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids. While these medications are effective, they are also associated with potential gastrointestinal and systemic adverse effects, especially when used repeatedly. As a result, there is growing interest in alternatives that can reduce inflammation and discomfort while minimizing systemic risks. Enzyme-based anti-inflammatory therapies, including combinations of trypsin, bromelain, and rutin, have been shown in medical and dental literature to provide meaningful reductions in pain, edema, and inflammation following surgical procedures. These proteolytic enzymes act by breaking down inflammatory mediators, reducing tissue permeability, and modulating cytokine responses. Trinase, a formulation containing trypsin, bromelain, and rutin, is widely used in postoperative care in other medical fields, yet its role in managing pain following endodontic procedures has not been adequately studied.

This randomized, double-blind, placebo-controlled clinical trial is designed to evaluate whether administering Trinase before root canal treatment can reduce the intensity of post-operative pain in patients diagnosed with symptomatic irreversible pulpitis. A total of 182 systemically healthy male patients, aged 18 to 50 years, will be recruited from the Endodontics Department at Fayoum University. The study population is limited to male participants to standardize biological pain variability and hormonal influences on pain perception. Eligible patients must present with restorable mandibular molar teeth and moderate to severe preoperative pain confirmed both clinically and radiographically.

Participants will be randomly assigned to one of two equal study arms. The Trinase group will receive a single oral Trinase tablet 30 minutes before treatment. The placebo group will receive a visually identical tablet administered under the same conditions. An assistant not involved in treatment will prepare and code all medication envelopes, ensuring allocation concealment. Both the operator and the participants will be blinded to group assignment.

All treatments will be performed in a single visit using standardized endodontic procedures. After local anesthesia, rubber-dam isolation, and access preparation, canal patency will be confirmed using stainless steel hand files. Working length will be determined electronically and confirmed radiographically. Mechanical instrumentation will be performed using Protaper Next rotary instruments according to manufacturer instructions. Irrigation will be performed using 2.5% sodium hypochlorite and EDTA gel lubricant. Upon completion of cleaning and shaping, canals will be dried, obturated using a modified single-cone technique with resin-based sealer, and restored temporarily with intermediate restorative material. All procedures are performed by a single experienced operator to eliminate inter-operator variability.