Dexamethasone in Lower Third Molar Surgery

Study Overview
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Brief Summary
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The aim of this randomized double-blind cross over clinical trial is to investigate effectiveness of different routes of applications (intramuscular and submucous at the site of surgery) and doses (4 mg and 8 mg) of Dexamethasone on swelling, trismus, pain and quality of life after lower third molar surgery.

Official Title
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Effectiveness of Different Application Modalities of Dexamethasone on Clinical Parameters and Quality of Life After Lower Third Molar Surgery

Conditions
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Impacted Third Molar Tooth

Intervention / Treatment
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* Procedure: Intramuscular application
* Procedure: Submucosal application
* Drug: 4mg Dexamethasone submucosal
* Drug: 8mg Dexamethasone submucosal
* Procedure: 4mg Dexamethasone preoperative
* Procedure: 4mg Dexamethasone postoperative


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy patients (ASA I) Bilateral symmetrically impacted lower third molars according to Pel-Gregory's and Winter's classification Exclusion Criteria: Heavy tobacco smokers Drug and / or alcohol abusers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intramuscular application<br>Intramuscular application of 4mg Dexamethasone | Procedure: Intramuscular application<br>* Patient receive 4mg of Dexamethasone by intramuscular application<br>|
| Experimental: Submucosal application<br>Submucosal application of 4mg Dexamethasone | Procedure: Submucosal application<br>* Patients receive 4mg of Dexamethasone by submucosal application<br>|
| Active Comparator: 4mg Dexamethasone submucosal<br>4mg Dexamethasone submucosal application | Drug: 4mg Dexamethasone submucosal<br>* Patients receive 4mg of submucosal Dexamethasone<br>* Other names: Dexasone;|
| Experimental: 8mg Dexamethasone submucosal<br>8mg Dexamethasone submucosal application | Drug: 8mg Dexamethasone submucosal<br>* Patients receive 8mg of submucosal Dexamethasone<br>* Other names: Dexasone;|
| Active Comparator: 4mg Dexamethasone postoperative<br>4mg Dexamethasone postoperative application | Procedure: 4mg Dexamethasone preoperative<br>* Patients receive 4mg of Dexamethasone preoperatively<br>|
| Experimental: 4mg Dexamethasone preoperative<br>4mg Dexamethasone postoperative application | Procedure: 4mg Dexamethasone postoperative<br>* Patients receive 4mg of Dexamethasone postoperatively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facial swelling (using 3 facial measurements (in millimeters) | We followed facial swelling 1, 3 and 7 days after intervention. Swelling in the operation site will be evaluated using 3 facial measurements (in millimeters): Tragus - Midline. Tragus - Corner of the mouth Gonion - Lateral canthus. | 1 day, 3 day, 7 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain (visual analog scale) | Postoperative pain will be evaluated using a visual analog scale, 100 mm in length ranging from 0 for  no pain to 100 for the worse imaginable pain. | 1 day, 3 day, 7 day | 
| Postoperative trismus (difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery) | Postoperative trismus will be measured as the difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery. | 1 day, 3 day, 7 day | 
| Postoperative discomfort (25-items custom made questionnaire) | Postoperative discomfort will be evaluated by filling out the 25-items custom made questionnaire that was designed to asses the patient's perception of adverse effects. | 4 day, 7 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexamethasone, Lower third molar surgery