The Role Of Trinase In Reducing Post-Operative Pain For Patients With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Egypt
Fayoum University
RECRUITING
Al Fayyum
Contact Information
Primary
Ahmed Maged Negm, Associate Professor
ahmed.maged@mgu.edu.eg
00201006600995
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2025-12-15
Participants
Target number of participants: 182
Treatments
Experimental: Trinase group
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.
Placebo_comparator: Placebo group
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.
Related Therapeutic Areas
Sponsors
Leads: Fayoum University

This content was sourced from clinicaltrials.gov

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