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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.

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Minor Trial completed Show 6 more changesShow less
    • Final enrollment: 400 participants (planned 182)
    • Primary and study completion dates changed from estimate of Dec 15, 2025 to Jan 5, 2026
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description shortened, about 12 words
    • Site details revised
  2. Minor Primary and study completion dates: Nov 15, 2025 to Dec 15, 2025v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 400 male patients aged 18 to 50 years who present with moderate to severe tooth pain were randomly assigned to receive either a Trinase tablet or a placebo 30 minutes before treatment. All root canal procedures were performed in a single visit using standard endodontic techniques. Pain levels were measured on a Visual Analogue Scale (VAS) before treatment and at 6, 12, 24, and 48 hours after treatment. Patients recorded 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.
Trial Details
NCT Number NCT07239505
Lead Sponsor Fayoum University
Conditions
(from sponsor)
Symptomatic Irreversible Pulpitis (SIP), Postoperative Pain After Endodontic Treatment, Endodontic Disease, Dental Pain
Related terms Dental Pulp Diseases, Postoperative Pain, Toothache
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov