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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Facial Swelling and Trismus Following Mandibular Third Molar Surgery | 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. |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Dr Virendra Singh, MDS | PGIDS ROHTAK | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pgids Rohtak | Rohtak | Haryana | 124001 | India |
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The patient, operator and outcome assessor will be masked to the group allocation.
|
| 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. |
|
| Preoperative baseline, Postoperative Day 1, Day 2, and Day 7 |
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002045 | Bupivacaine |
| D004837 | Epinephrine |
| D006821 | Hyaluronoglucosaminidase |
| D012965 | Sodium Chloride |
| D008012 | Lidocaine |
| D000449 | Aldehyde Reductase |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D006026 | Glycoside Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D011133 | Polysaccharide-Lyases |
| D019757 | Carbon-Oxygen Lyases |
| D008190 | Lyases |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000083 | Acetanilides |
| D000074408 | Aldo-Keto Reductases |
| D013401 | Sugar Alcohol Dehydrogenases |
| D002237 | Carbohydrate Dehydrogenases |
| D000429 | Alcohol Oxidoreductases |
| D010088 | Oxidoreductases |
| D064430 | NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases |
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