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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.

NCT07239505 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2025-12-01

No results posted yet for this study

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.

Conditions

  • Symptomatic Irreversible Pulpitis (SIP)
  • Postoperative Pain After Endodontic Treatment
  • Endodontic Disease
  • Dental Pain

Interventions

DRUG

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.

DRUG

placebo capsule

One identical-appearing placebo tablet administered orally 30 minutes prior to root canal treatment. Used as control.

Sponsors & Collaborators

  • Fayoum University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2025-12-15
Completion
2025-12-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07239505 on ClinicalTrials.gov