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

February 25, 2026 updated by: Postgraduate Institute of Dental Sciences Rohtak

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

  1. To compare postoperative facial swelling between the two interventions.
  2. To compare postoperative trismus (maximum interincisal mouth opening).

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).

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Haryana
      • Rohtak, Haryana, India, 124001
        • PGIDS Rohtak

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tumescent Steroid Infiltration with 2% Lidocaine and Adrenaline in Mandibular Third Molar

Participants received 2% lidocaine with adrenaline (1:2,00,000) using standard nerve block techniques. In addition, a 15 ml tumescent steroid solution was infiltrated submucosally after local anesthesia administration, targeting the mucogingival junction on the buccal aspect and the loose distal submucosa adjacent to the third molar.

The tumescent solution comprised normal saline, bupivacaine, dexamethasone (8 mg), hyaluronidase (1500 IU), and adrenaline (1:1000 dilution). Surgical removal was then performed using the same standardized technique as in the control arm. Postoperative medications and instructions were identical to the control arm.
Drug: Tumescent Infiltration (dexamethasone, bupivacaine, adrenaline, hyaluronidase, saline)
A 15 mL tumescent solution containing dexamethasone (8 mg), bupivacaine, adrenaline (1:1000 dilution), hyaluronidase (1500 IU), and normal saline was administered via submucosal infiltration after standard inferior alveolar nerve block using 2% lidocaine with adrenaline (1:2,00,000). The solution was injected at the mucogingival junction on the buccal aspect of the mandibular molars and into the loose distal submucosa adjacent to the impacted third molar prior to surgical extraction. The intervention aimed to reduce postoperative inflammatory sequelae including pain, swelling, and trismus.
Active Comparator: Conventional 2% Lidocaine with Adrenaline in Mandibular Third Molar Surgery
Participants received 2% lidocaine with adrenaline (1:2,00,000) administered via standard inferior alveolar nerve block, lingual nerve block, and long buccal nerve infiltration. No adjunctive anti-inflammatory or tumescent infiltration was administered. Surgical removal of the impacted mandibular third molar was performed using a standardized technique (Ward's/Modified Ward's flap, bone guttering with surgical bur, tooth sectioning when required, irrigation, and suturing). Postoperative medications and instructions were identical to the test arm.
Drug: 2% lignocaine with adr (1:2,00,000)
Standard inferior alveolar nerve block, lingual nerve block, and long buccal nerve infiltration were administered using 2% lidocaine with adrenaline (1:2,00,000). No adjunctive steroid or tumescent infiltration was used in this arm. Surgical removal of the impacted mandibular third molar was performed using a standardized technique including mucoperiosteal flap elevation, bone guttering, tooth sectioning when required, irrigation, and suturing. Postoperative medications and follow-up protocol were identical to the test group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Severity Following Mandibular Third Molar Surgery
Time Frame: Immediate postoperative period, Postoperative Day 1, Day 2, and Day 7
Postoperative pain will be assessed using a 10-point Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain. Pain scores will be recorded at immediate postoperative period and on postoperative Day 1, Day 2, and Day 7. The primary endpoint will be the difference in mean VAS pain scores between the control (2% lidocaine with adrenaline alone) and test (2% lidocaine with adrenaline plus tumescent steroid infiltration) sites, with particular emphasis on postoperative Day 1, when peak inflammatory pain is expected.
Immediate postoperative period, Postoperative Day 1, Day 2, and Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Facial Swelling and Trismus Following Mandibular Third Molar Surgery
Time Frame: Preoperative baseline, Postoperative Day 1, Day 2, and Day 7
Postoperative facial swelling will be measured using standardized linear facial measurements between fixed anatomical landmarks (lateral canthus to gonion, tragus to pogonion, and tragus to angle of mouth) using a flexible measuring scale. Trismus will be assessed by measuring maximum interincisal mouth opening (in millimeters). Measurements will be recorded preoperatively and on postoperative Day 1, Day 2, and Day 7. Intergroup comparisons will be performed between the control (2% lidocaine with adrenaline alone) and test (2% lidocaine with adrenaline plus tumescent steroid infiltration) sites.
Preoperative baseline, Postoperative Day 1, Day 2, and Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Dental Sciences Rohtak

Investigators

  • Study Director: Dr Virendra Singh, MDS, PGIDS Rohtak

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2025

Primary Completion (Actual)

December 23, 2025

Study Completion (Actual)

December 23, 2025

Study Registration Dates

First Submitted

February 22, 2026

First Submitted That Met QC Criteria

February 25, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aanand Niwas Mishra

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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