drugset / Trial / NCT07036237

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

NCT07036237

Enrolling by invitation 105 enrolled Dow University of Health Sciences
RandomizedParallel-groupQuadruple-blindPrevention

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

Timeline

Start
2025-03-04
Primary completion
2025-11-17
Completion
2025-11-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 1 ml Other
Subject Tramadol Other / unclassified 1 ml Other

Indications

No indication recorded.