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 | Completed

• 1 other identifier: 102517
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

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

Keywords

Visual Analogue Scale (VAS); Randomized Controlled Trial; Trinase; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Post-operative pain intensity assessed by Visual Analogue Scale (VAS)

  Pain intensity was 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 were categorized as no pain (0-4 mm), mild (5-44 mm), moderate (45-74 mm), severe (75-100 mm). Pain intensity was measured at baseline and at 6, 12, 24, and 48 hours after root canal treatment.

  Baseline, 6, 12, 24, and 48 hours after root canal treatment

Secondary Outcomes (1)

• Number of analgesic tablets consumed within 48 hours post-treatment

  Within 48 hours post-treatment

Study Arms (2)

Trinase group

EXPERIMENTAL

Patients received one tablet of Trinase (trypsin, bromelain, and rutin) orally 30 minutes before single-visit root canal treatment (RCT). RCT was performed under local anesthesia (2% lidocaine with 1:80,000 epinephrine) using a rubber dam and standard endodontic techniques. Postoperative pain was assessed using the Visual Analogue Scale (VAS) at 6, 12, 24, and 48 hours. Ibuprofen 400 mg was allowed as rescue analgesia if needed, and consumption was recorded.

Drug: Trinase

Placebo group

PLACEBO COMPARATOR

Patients received one identical-appearing placebo tablet orally 30 minutes before single-visit root canal treatment (RCT). RCT was performed using the same anesthesia, instrumentation, irrigation, and obturation protocol as the Trinase group. Postoperative pain was assessed using the Visual Analogue Scale (VAS) at 6, 12, 24, and 48 hours. Ibuprofen 400 mg was allowed as rescue analgesia if needed, and consumption was recorded.

Drug: placebo capsule

Interventions

Trinase DRUG

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.

Trinase group

placebo capsule DRUG

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Fayoum University

Al Fayyum, Faiyum Governorate, 12311, Egypt

Location

Related Links

• Description: Official ClinicalTrials.gov record for this study (NCT number assigned upon submission)

MeSH Terms

Conditions

Dental Pulp Diseases; Toothache; Pain, Postoperative

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both participants and the treating clinician are blinded to allocation. Medication and placebo are packed in identical opaque envelopes prepared by an independent assistant.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Endodontics

Model Details: Participants are randomized into two parallel groups: Trinase vs. placebo.

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: August 1, 2025
• Primary Completion: January 5, 2026
• Study Completion: January 5, 2026
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

EG (1)