Efficacy of Chronoterapy in Oral Surgery

Study Overview
=================
Brief Summary
-----------------
Lower third molar extraction is one of the most common treatments in oral surgery practice. It is a treatment with inherent complications such as postoperative pain, swelling or trismus. In order to minimize disconfort after extraction, analgesic and anti-inflammatory medication is prescribed. Recently, it is seen that circadian rhythm may play an important role on drugs metabolism, modulating its effect depending on the moment of administration. The aim of the study is to analyze if dosage modification of a Non Steroideal Anti-Inflammatory (ibuprofen) affects on postoperative pain, swelling and open mouth limitation comparing to the normal dosage.

Detailed Description
-----------------
A randomized crossover split-mouth clinical trial will be performed. After third molar extractions, patients will be prescribed ramdomly in one side wit the normal medication dosage while the contralateral side will be prescribed a modified dosage. Moreover, a blood sample will be obtained to analize the inflammatory profile.

Official Title
-----------------
Efficacy of the Dosage of a Non-steroidal Anti-inflammatory (Ibuprofen) on Inflammation and Postoperative Pain After Lower Third Molar Surgery.

Conditions
-----------------
Tooth, Impacted, Trismus, Pain, Inflammatory Response

Intervention / Treatment
-----------------
* Drug: Ibuprofen 400 mg
* Drug: Ibuprofen 400 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 35 years old Bilateral retained lower third molar Exclusion Criteria: NSAID allergic Contraindication for surgical removal of third molar

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Split-mouth design
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified dosage<br>Ibuprofen pill at morning and afternoon; Placebo at night | Drug: Ibuprofen 400 mg<br>* morning and afternoon<br>* Other names: Modified dosage;|
| Active Comparator: Normal dosage<br>Ibuprofen three times a day: morning, afternoon and night | Drug: Ibuprofen 400 mg<br>* morning, afternoon and night<br>* Other names: Conventional dosage;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative Pain | Postoperative pain with visual analogue scale (VAS) from 0 (no pain) to 10 (maximum pain) | From the day of the surgical procedure to the seventh-day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Swelling | Distance from tragus to pogonion in milimiters | Baseline and post operatory (day 1, day 3, day 7) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Third molar, Chronotherapy, Ibuprofen, Randomized