Actively Recruiting
Effect of Premedication on Post-endodontic Pain in Patients With Symptomatic Irreversible Pulpitis, a Triple-blinded Randomized Control Trial
Led by Gulf Medical University · Updated on 2024-11-04
48
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the effects of preoperative use of alpha-chemo-trypsin, ibuprofen, and acetaminophen in controlling pain after root canal treatment in patients with symptomatic irreversible pulpitis. The study seeks to understand which premedication works best to manage post-endodontic pain. It is a randomized, triple-blinded clinical trial sponsored by Gulf Medical University and focuses on adults aged 20 to 50 years. Participants will receive one of the study medications—alpha-chemo-trypsin, ibuprofen, acetaminophen, or a placebo—one hour before undergoing root canal treatment. The procedure includes local anesthesia, access cavity preparation, cleaning and shaping of the root canal, obturation, and final restoration following a standardized protocol. During the study, patients will report their pain levels using a visual analogue scale at 6, 12, 24, and 48 hours after the treatment. Researchers will record preoperative pain scores and monitor post-endodontic pain intensity at these intervals to evaluate the effectiveness of each premedication. The total study duration for each participant corresponds to the follow-up pain assessments within two days after treatment.
CONDITIONS
Brief Title
Premedication on Post-endodontic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eligible for root canal treatment
- Diagnosed with symptomatic irreversible pulpitis with normal apical tissue in mandibular molars
- Aged between 20 and 50 years
- All genders
You will not qualify if you...
- Taking any medication or analgesics for pain management
- Having any systemic health issues
- Allergic to trypsin-chymotrypsin, ibuprofen, or paracetamol
- Pregnant
- Having non-restorable teeth
- Having immature roots
- Presence of calcifications
- Presence of resorptions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure with assessments up to 48 hours post-treatment
Participants receive premedication followed by root canal treatment including anesthesia, cleaning, shaping, obturation, and restoration.
1 premedication and treatment visit with pain assessments at 6, 12, 24, and 48 hours post-treatment
Trial Site Locations
Total: 1 location
1
Gulf Medical University
Ajman, United Arab Emirates, 4184
Actively Recruiting
Research Team
E
Elsewify
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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