Impact of Preemptive Intravenous Ibuprofen on Postoperative Edema and Trismus in the Third Molar Teeth

Study Overview
=================
Brief Summary
-----------------
this study was planned to investigate the antiinflammatory activity of preemptive intravenous ibuprofen on inflammatory complications such as edema and trismus after third molar tooth surgery

Official Title
-----------------
Impact of Preemptive Intravenous Ibuprofen on Postoperative Edema and Trismus in the Third Molar Teeth

Conditions
-----------------
Trismus, Edema

Intervention / Treatment
-----------------
* Drug: arveles
* Drug: intrafen
* Other: placebos


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective 3. Molar tooth extraction Patients between the ages of 20-35 Patients who are symptomatic 3. Molar tooth angular or horizontal settled patients Exclusion Criteria: Patients who refuse to participate in the study Patients under 20 years old, over 35 years old Patients who are allergic to known non-steroidal anti-inflammatory drugs Pregnant patients Patients with severe hepatic insufficiency Patients with severe renal insufficiency

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: arveles<br>800 mg ibuprofen and 50 mg arveles in 150 cc normal saline before operation will be given in 30 minutes. | Drug: arveles<br>* 800 mg ibuprofen and 50 mg dexketoprofen in 150 cc normal saline before operation will be given in 30 minutes. The edema size, mouth opening (trismus) will be recorded in all patients in the preoperative period, postoperative period, postoperative 48th hour and 1 st week.<br>* Other names: dexketoprofen;Drug: intrafen<br>* 800 mg ibuprofen in 150 cc normal saline before operation will be given in 30 minutes.The edema size, mouth opening (trismus) will be recorded in all patients in the preoperative period, postoperative period, postoperative 48th hour and 1 st week.<br>* Other names: ibuprofen i.v.;Other: placebos<br>* 150 cc normal saline before operation will be given in 30 minutes.The edema size, mouth opening (trismus) will be recorded in all patients in the preoperative period, postoperative period, postoperative 48th hour and 1 st week.<br>|
| Active Comparator: intrafen<br>intrafen 800 mg in 150 cc normal saline before operation will be given in 30 minutes. | Drug: arveles<br>* 800 mg ibuprofen and 50 mg dexketoprofen in 150 cc normal saline before operation will be given in 30 minutes. The edema size, mouth opening (trismus) will be recorded in all patients in the preoperative period, postoperative period, postoperative 48th hour and 1 st week.<br>* Other names: dexketoprofen;Drug: intrafen<br>* 800 mg ibuprofen in 150 cc normal saline before operation will be given in 30 minutes.The edema size, mouth opening (trismus) will be recorded in all patients in the preoperative period, postoperative period, postoperative 48th hour and 1 st week.<br>* Other names: ibuprofen i.v.;Other: placebos<br>* 150 cc normal saline before operation will be given in 30 minutes.The edema size, mouth opening (trismus) will be recorded in all patients in the preoperative period, postoperative period, postoperative 48th hour and 1 st week.<br>|
| Placebo Comparator: placebos<br>Pre-operative 150 cc normal saline will be delivered in 30 minutes | Drug: arveles<br>* 800 mg ibuprofen and 50 mg dexketoprofen in 150 cc normal saline before operation will be given in 30 minutes. The edema size, mouth opening (trismus) will be recorded in all patients in the preoperative period, postoperative period, postoperative 48th hour and 1 st week.<br>* Other names: dexketoprofen;Drug: intrafen<br>* 800 mg ibuprofen in 150 cc normal saline before operation will be given in 30 minutes.The edema size, mouth opening (trismus) will be recorded in all patients in the preoperative period, postoperative period, postoperative 48th hour and 1 st week.<br>* Other names: ibuprofen i.v.;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Edema size measured by tape measure method | the effect of preemptive intravenous ibuprofen on postoperative edema size | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum mouth opening measured with vernier caliper | the effect of preemptive intravenous ibuprofen on postoperative trismus rate | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Preemptive intravenous ibuprofen, trismus, edema, Third molar tooth extraction, Antiinflammatory effect