Clinical Trial

Comparison Of The Effect Of Final Rinse Of Tramadol and Dexamethasone on Post-Endodontic Pain in Teeth With SIP

Enrolling by Invitation
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Record status
This record was last updated June 25, 2025 (before its estimated November 17, 2025 completion). Its status may not reflect the trial's current state.
Summary
Briefly, 105 teeth with symptomatic irreversible pulpitis will be included in the study and randomly allocated to three groups (A, B and C). Pre-Operative pain score using VAS will be taken after which root canal treatment shall be initiated. Group A (35 teeth) will receive normal saline as a final irrigant. 35 teeth each of Groups B and C will receive Dexamethasone and Tramadol Solutions, respectively as final irrigants. Post-operative pain scores will be recorded after 6, 12, 24 and 48 hours after the procedure. Statistical analysis will be performed using SPSS version 26.0. Mean comparison of pre-treatment and post-treatment VAS scores will be done by repeated measure two-way ANOVA. Post-hoc LSD test will be applied for pairwise comparison within and/or between groups. The sample size of 105 subjects (35 including 5 as a drop out per group) is calculated using PASS version 15, based on two sample proportion with 95% confidence of interval and 80% power of test, no pain in dexamethasone (81.7%) and drug2
Trial Details
NCT Number NCT07036237
Lead Sponsor Dow University of Health Sciences
Conditions Post-endodontic Pain
Enrollment 105 participants
Start Date 2025-03-04
Primary Completion 2025-11-17 (estimated)
Study Completion 2025-11-17 (estimated)
Updated on ClinicalTrials.gov 2025-06-25