Comparative Assessment of Preoperative Versus Postoperative Submucosal Dexamethasone on Postoperative Complications Following Surgical Extraction of Mandibular Third Molar: Randomized Controlled Trial

Study Overview
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Brief Summary
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The goal of this study is to compare the pain, edema and trismus of pre-operative versus post-operative submucosal dexamethasone in lower third molar surgical extraction done in healthy population.This is comparative study, will be conducted in patient indicated for surgical extraction of mandibular third molar at the department of oral and maxillofacial surgery, college of dental surgery, BPKIHS, Nepal. Verbal and written informed consent will be taken. Participants meeting inclusion criteria will be included in the study and will be divided into two groups, group A(pre-operative submucosal 2ml of 4mg/ml dexamethasone will be administered prior to placing an incision in buccal vestibule) and groupB(post-operative submucosal 2ml of 4mg/ml dexamethasone will be administered soon after closure of the incision site).Baseline measurement of interincisal distance for mouth opening, distance between the tragus to corner of mouth, gonion to corner of mouth and outer canthus to gonion as baseline for edema taken prior extraction. Extraction is carried out using standard protocol and postoperative antibiotics and analgesics are given. Rescue analgesic tramadol is prescribed and asked to be taken only pain score exceeds 7.Patient is kept on follow up for 2nd, 5th and 7th days and assessment of pain using numeric visual analogue scale, swelling using facial and trismus using interincial measurements and recorded. Any adverse effect of drugs will be recorded. The data collected will be entered in Microsoft excel sheet. It will then be transferred into SPSS(Statistical package for Social Sciences) for statistical analysis.

Detailed Description
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Introduction:Third molar impaction is a chronic disorder that often necessitates tooth extraction. Impaction is characterized as the inability of a tooth to erupt at its proper location in the dental arch during its usual growth time.The surgical extraction of lower third molars is the most frequent intervention in oral surgery. This procedure is often associated with significant postsurgical sequelae that may have both biological and social impact. Besides severe complications such as dysaesthesia, severe infection, fracture, and dry socket, patients frequently complain of pain, swelling, and limitation in mouth opening (Trismus) throughout the postoperative course due to the inflammatory response following the surgical injury. To control postoperative inflammation and symptoms associated, it is necessary to provide an adequate anti-inflammatory therapy and various medications have been prescribed for the same. For several decades surgeons administered corticosteroids before or just after third molars' surgery to reduce inflammation and associated symptoms after oral surgery. Corticosteroids mechanism of action is the inhibition of the enzyme Phospholipase A2 (PLA 2), which reduces the release of arachidonic acid in the cells of the inflamed area.This will decrease prostaglandins and leukotriene synthesis; therefore reducing the accumulation of neutrophils has been the greatest advantage of corticosteroids compared to non-steroidal anti-inflammatory drugs. The aim of this study was to evaluate the effect of preoperative versus postoperative administration of submucosal Dexamethasone on postoperative discomfort including pain, edema, and trismus following lower third molar surgery in order to allow a better welfare of the patient and to return the patient to the normal activity following the surgery. And to determine the efficacy of single dose 2 ml/8 mg submucosal dexamethasone injection in the buccal vestibule in proximity to the surgical site. Rational:Pain and edema are the most frequent postoperative sequelae to surgical removal of impacted teeth, all of which are due to the local inflammatory response. The inflammation induced by tissue damage is the primary cause of acute postoperative pain after third molar extraction. Edema after third molar surgery is caused by extravasation of fluid by traumatized tissues as a consequence of the disruption or obstruction of lymph arteries, culminating in the termination of lymph drainage, which accumulates in the tissues. Adjunctive use of corticosteroids to decrease tissue mediators of inflammation and reduce fluid transudation and edema is common in surgical procedures. Corticosteroids inhibits the enzyme Phospholipase A2 (PLA 2), which reduces the release of arachidonic acid in the cells of the inflamed area.Dexamethasone has higher potency, lower sodium retaining ability and longer half-life. Long-acting steroids outperform short-acting steroids, and submucosal steroid administration has similar consequences as intravenous and intramuscular routes. Also rate of absorption is highly dependent on the blood flow to the site.Submucosal dexamethasone is quite simple, less invasive, painless, convenient for the surgeon and the patient and offers a low cost solution for the typical discomfort associated with the extraction of impacted lower third molar. Also,submucosal injection offers advantage of concentrating the drug near the surgical area with less systemic absorption and no further manipulation of the tissues.

Official Title
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Randomized Controlled Trial on Assessment of Preoperative Versus Postoperative Submucosal Dexamethasone On Postoperative Complications Following Surgical Extraction Of Mandibular Third Molar.

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinically healthy patients (American Society of Anesthesiology I) with impacted lower third molar. Age ≥18 to ≤ 55 years No history of previous pericoronitis Exclusion Criteria: • Patients who are ASA II to ASA VI. Patients already on corticosteriods through any route. Patients with known allergy to any drugs. Pregnant and lactating females Patient not consenting to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drug arm preoperative<br>receiving pre-operative submucosal dexamethasone 2ml of 4mg/ml solution into buccal vestibule prior to the incision. | Drug: Dexamethasone<br>* Submucosal application<br>* Other names: treatment;|
| Active Comparator: Drug arm postoperative<br>receiving immediately post-operative submucosal dexamethasone 2ml of 4mg/ml solution in the buccal vestibule after placement of last suture. | Drug: Dexamethasone<br>* Submucosal application<br>* Other names: treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PAIN MEASUREMENT POSTOPERATIVELY AFTER SURGICAL EXTRACTION OF 3RD MOLAR | USING NUMERIC PAIN SCORE, 1 BEING LEAST PAINFUL AND 10 BEING WORST PAIN. | BASELINE, SECOND, FIFTH AND SEVENTH POST OPERATIVE DAY | 
| SWELING | facial measurements (outer canthus to gonion, tragus of ear to corner of mouth and corner of mouth to gonion | BASELINE,SECOND, FIFTH AND SEVENTH POSTOPERATIVE DAY | 
| TRISMUS | MEASURING NON-FORCED INTERINCISAL DISTANCE | BASELINE,SECOND, FIFTH AND SEVENTH POSTOPERATIVE DAY |