NCT03179813

Topical Hydrocortisone for Pain and Edema Control After Third Molar Surgery

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Accepted

Summary

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

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).

Conditions

• Impacted Third Molar Tooth

Interventions

Type	Name	Description
PROCEDURE	Hydrocortisone	During the third molar extraction the hydrocortisone solution will be used in the test group
PROCEDURE	Control	During the third molar extraction the saline solution will be used in the control group

Timeline

• Start date: 2017-05-01
• Primary completion: 2018-01-03
• Completion: 2018-03-01
• First posted: 2017-06-07
• Last updated: 2018-03-07

Locations

1 site across 1 country: Brazil