Evaluation of the Effects of Pre-operative Deflazacort on Post-operative Pain, Edema and Trismus

Study Overview
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Brief Summary
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Removal of impacted lower third molar teeth is one of the most common oral surgical procedures, and these operations often lead to various complications in patients. Antibiotics, analgesics and/or anti-inflammatory drugs are prescribed for the treatment of complications encountered. Anti-inflammatory is the property of a substance or treatment that reduces inflammation or swelling. Anti-inflammatory drugs make up about half of analgesics, remedying pain by reducing inflammation as opposed to opioids, which affect the central nervous system to block pain signaling to the brain. Based on this information, in this study, it is aimed to evaluate the effects of deflazacort preoperatively on the postoperative pain, swelling and trismus.

Official Title
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Evaluation of the Effects of Pre-operative Deflazacort on Post-operative Pain, Edema and Trismus in Impacted Lower Third Molar Surgery

Conditions
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Impacted Third Molar Tooth

Intervention / Treatment
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* Drug: Deflazacort 30 MG Oral Tablet
* Drug: Sugar pill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: absence of any systemic disease, having bilateral impacted mandibular third molar teeth in a similar position absence of allergy to any of the drugs used in the study, absence of pregnancy/lactating state, no history of any medication use during at least 2 week before the operation. Exclusion Criteria: not regularly coming to the controls, not using their medicines regularly, using any additional medication that may affect the outcome of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deflazacort<br>Deflazacort is a glucocorticoid used as an anti-inflammatory drug. We used deflazacort 30 mg tablet. Patient took a pill once preoperatively (1 hour ago) in third molar surgery. | Drug: Deflazacort 30 MG Oral Tablet<br>* After the taken a deflazacort pill once preoperatively (one hour ago), local anesthesia was obtained using 2 ml articaine hydrochloride 40 mg/ml with epinephrine 0.01 mg/ml . The horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised. In all surgical procedures, bone removal and/or tooth sectioning were performed under sterile saline irrigation. Following the extraction, granulation tissues were removed, and bleeding was controlled. Finally, the mucoperiosteal flap was repositioned by 3.0 silk sutures.<br>* Other names: FLANTADIN 30 MG 10 TABLET;|
| Placebo Comparator: Sugar pill<br>Placebo is an inert substance or treatment which is designed to have no therapeutic value. Patients took sugar pill for plasebo once one hour before operation. | Drug: Sugar pill<br>* Sugar pill<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain | Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain). | Postoperative 1st day | 
| Postoperative Pain | Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain). | Postoperative 2nd day | 
| Postoperative Edema | Postoperative edema was evaluated by the distance between predetermined facial anatomic landmarks (from the mandibular angle to lateral corner of the eye, base of the nose, labial commissura, and soft tissue pogonion) which was measured with using thread and millimeter ruler. | Postoperative 2nd day | 
| Postoperative Trismus | Postoperative trismus was evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper. | Postoperative 2nd day | 
| Postoperative Pain | Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain). | Postoperative 3d day | 
| Postoperative Pain | Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain). | Postoperative 4th day | 
| Postoperative Pain | Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain). | Postoperative 5th day | 
| Postoperative Pain | Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain). | Postoperative 6th day | 
| Postoperative Pain | Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain). | Postoperative 7th day | 
| Postoperative Edema | Postoperative edema was evaluated by the distance between predetermined facial anatomic landmarks (from the mandibular angle to lateral corner of the eye, base of the nose, labial commissura, and soft tissue pogonion) which was measured with using thread and millimeter ruler. | Postoperative 7th day | 
| Postoperative Trismus | Postoperative trismus was evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper. | Postoperative 7th day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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deflazacort, pain, edema, trismus