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Completed

NCT Number: NCT07436546

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

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

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Key information

Conditions

Impacted Third Molar Impacted Third Molar Tooth Third Molar Extraction Third Molar Extraction Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pgids Rohtak

Rohtak, Haryana, 124001, India

About this study

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

  • To compare postoperative facial swelling between the two interventions.
  • 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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tumescent Infiltration (dexamethasone, bupivacaine, adrenaline, hyaluronidase, saline)

Drug

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.

2% lignocaine with adr (1:2,00,000)

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Postgraduate Institute of Dental Sciences Rohtak

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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