drugset / Trial / NCT07436546

Prospective Evaluation of Efficacy of Tumescent Steroid Infiltration in Mandibular Third Molar Surgery: a Split Mouth Randomized Study

NCT07436546

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The aim of this study is to evaluate the efficacy of tumescent solution on post operative sequalae in patients treated for surgical removal of impacted lower third molar. The objectives are Primary Objective 1\. To evaluate post-operative pain severity after surgical removal of impacted lower 3rd molar under Lidocaine 2% with adrenaline with and without Tumescent steroid infiltration. Secondary objectives 1. To evaluate post-operative trismus after surgical removal of impacted lower 3rd molar under Lidocaine 2% with adrenaline with and without Tumescent steroid infiltration 2. To evaluate post operative swelling after surgical removal of impacted lower 3rd molar under Lidocaine 2% with adrenaline with and without Tumescent steroid infiltration

Timeline

Start
2025-03-23
Primary completion
2025-12-23
Completion
2025-12-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified Subcutaneous
Subject Dexamethasone Small molecule 8 mg Subcutaneous
Subject Epinephrine Other / unclassified Subcutaneous
Subject rHuPH20 Protein / enzyme biologic 1500 iu Subcutaneous
Comparator Lidocaine Other / unclassified 2 % Other