Skip to content

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
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06671743
Enrollment
48
Registered
2024-11-04
Start date
2024-09-01
Completion date
2026-11-01
Last updated
2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premedication

Brief 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.

Interventions

PROCEDURERoot 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.

Sponsors

Gulf Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Eligibility for root canal treatment Patients diagnosed with symptomatic irreversible pulpitis with normal apical tissue in mandibular molars

Exclusion criteria

* • Patient under any medication or analgesic intake for pain management. * Patients with any systemic health issues * Patient allergies to trypsin-chymotrypsin, ibuprofen, and paracetamol * Pregnancy. * Non-restorable teeth. * Immature roots. * Calcifications. * Resorptions.

Design outcomes

Primary

MeasureTime frameDescription
Post-endodontic pain score6 hoursPost operative pain score will be recorded using the visual analogue pain scale, where the patient will mark a point on a 10-cm line representing a continuum from 'no pain' to 'worst pain imaginable.

Countries

United Arab Emirates

Contacts

Primary ContactElsewify
dr.tarek@gmu.ac.ae+971585078876

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026