Impacted Third Molar, Impacted Third Molar Tooth, Third Molar Extraction, Third Molar Extraction Surgery
Conditions
Keywords
impacted third molar, tumescent solution, third molar surgery, disimpaction
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. 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
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).
Interventions
DRUGTumescent 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.
DRUG2% 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.
Sponsors
Postgraduate Institute of Dental Sciences Rohtak
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The patient, operator and outcome assessor will be masked to the group allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Severity Following Mandibular Third Molar Surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Facial Swelling and Trismus Following Mandibular Third Molar Surgery | 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. |
Countries
India
Contacts
STUDY_DIRECTORDr Virendra Singh, MDS
PGIDS ROHTAK
Outcome results
None listed