Prospective Evaluation of Efficacy of Tumescent Steroid Infiltration in Mandibular Third Molar Surgery: a Split Mouth Randomized Study
Prospective Evaluation of Efficacy of Tumescent Steroid Infiltration in Mandibular Third Molar Surgery: a Split Mouth Randomized Study
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
Title
Prospective Evaluation of the Efficacy of Tumescent Steroid Infiltration in Mandibular Third Molar Surgery: A Split-Mouth Randomized Controlled Clinical Trial
Background and Rationale
Surgical removal of impacted mandibular third molars is one of the most frequently performed procedures in oral and maxillofacial surgery. Despite being routine, it is commonly associated with postoperative complications such as pain, facial swelling (edema), and trismus. These sequelae typically peak within the first 24-48 hours and significantly affect patient comfort, oral hygiene, mastication, and quality of life.
Corticosteroids have been widely used via systemic and local routes to minimize postoperative inflammatory morbidity. Submucosal and intramuscular dexamethasone have demonstrated significant reductions in postoperative edema and pain; however, optimal delivery technique remains under investigation.
Tumescent anesthesia, originally developed for liposuction, involves infiltration of a dilute solution containing local anesthetic, vasoconstrictor, and adjunct agents to produce tissue tumescence. This technique enhances hemostasis, prolongs anesthesia, and may reduce inflammatory sequelae. While tumescent anesthesia has been explored in plastic, dermatologic, and orthognathic surgery, its role in impacted mandibular third molar surgery remains inadequately studied.
Therefore, this study was designed to evaluate the efficacy of tumescent steroid infiltration as an adjunct to conventional local anesthesia in reducing postoperative pain, swelling, and trismus following mandibular third molar surgery.
Study Objectives Primary Objective
To evaluate postoperative pain severity following surgical removal of impacted mandibular third molars using:
2% lidocaine with adrenaline alone versus 2% lidocaine with adrenaline combined with tumescent steroid infiltration
Secondary Objectives
Study Design
Type of Study: Prospective, randomized, double-blind, split-mouth controlled clinical trial
Study Setting: Department of Oral and Maxillofacial Surgery, Post Graduate Institute of Dental Sciences (PGIDS), Rohtak, Haryana, India
Blinding: Double-blind (Patient and outcome assessor blinded)
In the split-mouth design, each patient served as their own control. One side was randomly assigned to receive conventional local anesthesia (control), and the contralateral side received local anesthesia with adjunctive tumescent steroid infiltration (test).
Inclusion Criteria - ASA Class I subjects aged over 18 years presenting with bilateral impacted mandibular third molars of similar difficulty indices.
Exclusion Criteria: - Existence of acute infection and/or swelling and pain at the time of surgery with systemic disorders or history of complications associated with local anesthetics.