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 | Recruiting

• 1 other identifier: 102517
• Study Type: interventional
• Target: 182
• 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 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

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 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.

  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 receive one tablet of Trinase (trypsin, bromelain, and rutin) orally 30 minutes before single-visit root canal treatment (RCT). RCT is performed under local anesthesia (2% mepivacaine with 1:100,000 epinephrine), rubber dam isolation, using ProTaper Next rotary files up to X3, 2.5% NaOCl irrigation, EDTA gel, obturation with modified single-cone technique and Adseal resin sealer. Post-operative pain assessed via VAS at 6, 12, 24, 48 hours. Analgesic rescue (Trinase) allowed if needed; consumption recorded.

Drug: Trinase

Placebo group

PLACEBO COMPARATOR

Patients receive one identical-appearing placebo tablet orally 30 minutes before identical single-visit RCT procedure (same anesthesia, instrumentation, irrigation, obturation protocol). Post-operative pain assessed via VAS at 6, 12, 24, 48 hours. Analgesic rescue (Trinase) allowed if needed; consumption 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

RECRUITING

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

Central Study Contacts

Ahmed Maged Negm, Associate Professor

CONTACT

00201006600995; ahmed.maged@mgu.edu.eg

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: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

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

Locations

EG (1)