NCT06671743

Premedication on Post-endodontic Pain

Effect of Premedication on Post-endodontic Pain in Patients With Symptomatic Irreversible Pulpitis, a Triple-blinded Randomized Control Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Gulf Medical University · Academic / Other
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to compare the efficacy of preoperative administration of alpha-chemo-trypsin, ibuprofen, and acetaminophen in managing post-endodontic pain in patients with symptomatic irreversible pulpitis. The main question it aims to answer is: What is the efficacy of preoperative administration of alpha-chemo-trypsin, ibuprofen, and acetaminophen in managing post-endodontic pain in patients with symptomatic irreversible pulpitis? Participants will undergo root canal treatment after premedication. Researchers will compare \[alpha-chemo-trypsin, ibuprofen, and acetaminophen\] to see the intensity of post-endodontic pain.

Conditions

• Premedication

Interventions

Type	Name	Description
PROCEDURE	Root canal treatment	History of presenting illness will be recorded and vitality testing will be done in addition to pre-operative radiograph. Patient will read and sign the consent form. Pre-operative pain score will be recorded using visual analogue scale. The patient will take the preoperative medication 1 hour prior to the procedure. The patient will receive 1 cartridge of LA with inferior alveolar nerve block (2% lidocaine 1:80000) and a rubber dam will be used for isolation. Access cavity will be prepared and working length will be determined. Cleaning and shaping of the root canal system will be performed followed by obturation using a standardized protocol followed by final coronal restoration. Postoperative pain score will be recorded at the 6, 12, 24, and 48 hours using visual analogue pain scale.

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-07-01
• Completion: 2026-11-01
• First posted: 2024-11-04
• Last updated: 2024-11-04

Locations

1 site across 1 country: United Arab Emirates

Regulatory

• FDA-regulated drug study