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

NCT07436546 | Completed

• 1 other identifier: Aanand Niwas Mishra
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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

Conditions

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

Keywords

impacted third molar; tumescent solution; third molar surgery; disimpaction

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Severity Following Mandibular Third Molar Surgery

  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 Outcomes (1)

• Postoperative Facial Swelling and Trismus Following Mandibular Third Molar Surgery

  Preoperative baseline, Postoperative Day 1, Day 2, and Day 7

Study Arms (2)

Tumescent Steroid Infiltration with 2% Lidocaine and Adrenaline in Mandibular Third Molar

EXPERIMENTAL

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)

Conventional 2% Lidocaine with Adrenaline in Mandibular Third Molar Surgery

ACTIVE COMPARATOR

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)

Interventions

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.

Tumescent Steroid Infiltration with 2% Lidocaine and Adrenaline in Mandibular Third Molar

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.

Conventional 2% Lidocaine with Adrenaline in Mandibular Third Molar Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Pgids Rohtak

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Interventions

Dexamethasone; Bupivacaine; Epinephrine; Hyaluronoglucosaminidase; Sodium Chloride; Lidocaine; Aldehyde Reductase

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Polysaccharide-Lyases; Carbon-Oxygen Lyases; Lyases; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Acetanilides; Aldo-Keto Reductases; Sugar Alcohol Dehydrogenases; Carbohydrate Dehydrogenases; Alcohol Oxidoreductases; Oxidoreductases; NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases

Study Officials

• Dr Virendra Singh, MDS

  PGIDS ROHTAK

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patient, operator and outcome assessor will be masked to the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2026
• First Posted: February 27, 2026
• Study Start: March 23, 2025
• Primary Completion: December 23, 2025
• Study Completion: December 23, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

IN (1)