Topical Hydrocortisone for Pain and Edema Control After Third Molar Surgery

Study Overview
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Brief Summary
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The investigators set out to develop a clinical trial in order to test the topical use of hydrocortisone as a intraoperative irrigant solution. As this route of administration as well as being low cost and not add new steps to the surgical procedure, can contribute to an improved quality of life in the postoperative period of patients undergoing extraction of third molars.

Detailed Description
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Third molars are the teeth with a higher prevalence of failure in eruption and surgery for extraction of these impacted teeth is one of the most commonly procedures performed by the oral and maxillofacial surgeon. In most cases these are not traumatic procedures, however factors such as patient age, habits, degree of tooth impaction and surgeon experience can influence the surgical trauma and therefore the postoperative period could include swelling and pain of varying magnitudes which can significantly affect the patient's quality of life. The study is designed as a prospective, randomized, placebo-controlled, split-mouth crossover trial. All the patients will be informed of the experimental methodology and signed a institutionally approved consent form. The study is been conducted in compliance with Declaration of Helsinki (1989), and was revised by the Institutional Ethical Committee (protocol 1.167.908).

Official Title
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Topical Hydrocortisone for Pain and Edema Control After Third Molar Surgery: a Clinical, Crossover, Randomized, Double-blind, Controlled Study

Conditions
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Impacted Third Molar Tooth

Intervention / Treatment
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* Procedure: Hydrocortisone
* Procedure: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Health patients of any sex, with symmetric bilateral bone-impacted mandibular third molars requiring surgical removal, and with no history of allergy to the drugs used in this study. Exclusion Criteria: Use of analgesic or anti-inflammatory drugs 24 hours before the surgery. Pregnant or breastfeeding patients, Use of other drugs beyond of that one's prescribed by the researchers;

Ages Eligible for Study
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Minimum Age: 14 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrocortisone group<br>Intraoperative topical use of hydrocortisone as a irrigation solution in third molar surgery. | Procedure: Hydrocortisone<br>* During the third molar extraction the hydrocortisone solution will be used in the test group<br>|
| Placebo Comparator: Control Group<br>Intraoperative irrigation with saline solution. | Procedure: Control<br>* During the third molar extraction the saline solution will be used in the control group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Edema | Change in edema measures | From the preoperative moment to the second postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Quantitative evaluation (amount of analgesic medication intake) | Up to 2 days (amount of analgesic medication intake form the immediate postoperative moment to the second postoperative day) | 
| Pain | Subjective evaluation - Visual Analog Scale | Up to 2 days (from the immediate postoperative moment to the second postoperative day) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hydrocortisone, postoperative pain, edema, third molar, oral surgery