Premedication on Post-endodontic Pain
Effect of Premedication on Post-endodontic Pain in Patients With Symptomatic Irreversible Pulpitis, a Triple-blinded Randomized Control Trial
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2024
CompletedFirst Submitted
Initial submission to the registry
October 30, 2024
CompletedFirst Posted
Study publicly available on registry
November 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
November 4, 2024
November 1, 2024
1.8 years
October 30, 2024
November 1, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
Post-endodontic pain score
Post 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.
6 hours
Post-endodontic pain score
Post 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.
12 hours
Post-endodontic pain score
Post 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.
24 hours
Post-endodontic pain score
Post 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.
48 hours
Study Arms (4)
trypsin-chymotrypsin
EXPERIMENTALIbuprofen
ACTIVE COMPARATORparacetamol
ACTIVE COMPARATORplacebo
PLACEBO COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- Eligibility for root canal treatment Patients diagnosed with symptomatic irreversible pulpitis with normal apical tissue in mandibular molars
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gulf Medical University
Ajman, 4184, United Arab Emirates
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2024
First Posted
November 4, 2024
Study Start
September 1, 2024
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
November 4, 2024
Record last verified: 2024-11