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.
Systemically healthy male patients (ASA I or II)
Aged 18 to 50 years
Presenting with symptomatic irreversible pulpitis in a restorable mandibular molar
Preoperative moderate to severe pain (VAS ≥45 mm)
History of allergy or intolerance to Trinase or any of its components (trypsin, bromelain, rutin)
Vertical root fracture
External or internal root resorption
Periodontal pocket depth >5 mm
Parallel
Trinase
DrugOne 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
DrugOne identical-appearing placebo tablet administered orally 30 minutes prior to root canal treatment. Used as control.
Post-operative pain intensity assessed by Visual Analogue Scale (VAS)
Pain intensity recorded by patients on a 10-cm Visual Analogue Scale (VAS) where 0 = no pain and 100 = pain as bad as it could be. Scores categorized as: no pain (0-4 mm), mild (5-44 mm), moderate (45-74 mm), severe (75-100 mm). Measured at baseline and post-operatively.
Number of analgesic tablets consumed within 48 hours post-treatment
Total number of rescue analgesic tablets (Trinase) taken by patients within 48 hours after root canal treatment, as recorded on provided charts during follow-up.
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