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.
The Role Of Trinase In Reducing Post-Operative Pain For Patients With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
Fayoum University
182 participants
Aug 1, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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)
- Normal periapical tissue (no radiolucency, pocket depth ≤5 mm, mobility ≤ Grade I)
Exclusion Criteria8
- Medically compromised patients (ASA III or higher)
- 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
- Tooth mobility Grade II or III
- Presence of periapical lesion (radiolucency)
- Female patients (to standardize pain perception and hormonal factors)
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Interventions
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.
One identical-appearing placebo tablet administered orally 30 minutes prior to root canal treatment. Used as control.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07239505