Topical Hydrocortisone for Pain and Edema Control After Third Molar Surgery
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|ClinicalTrials.gov Identifier: NCT03179813|
Recruitment Status : Completed
First Posted : June 7, 2017
Last Update Posted : March 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Impacted Third Molar Tooth||Procedure: Hydrocortisone Procedure: Control||Phase 4|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Topical Hydrocortisone for Pain and Edema Control After Third Molar Surgery: a Clinical, Crossover, Randomized, Double-blind, Controlled Study|
|Actual Study Start Date :||May 1, 2017|
|Actual Primary Completion Date :||January 3, 2018|
|Actual Study Completion Date :||March 1, 2018|
Experimental: Hydrocortisone group
Intraoperative topical use of hydrocortisone as a irrigation solution in third molar surgery.
During the third molar extraction the hydrocortisone solution will be used in the test group
Placebo Comparator: Control Group
Intraoperative irrigation with saline solution.
During the third molar extraction the saline solution will be used in the control group
- Edema [ Time Frame: From the preoperative moment to the second postoperative day ]Change in edema measures
- Pain [ Time Frame: Up to 2 days (amount of analgesic medication intake form the immediate postoperative moment to the second postoperative day) ]Quantitative evaluation (amount of analgesic medication intake)
- Pain [ Time Frame: Up to 2 days (from the immediate postoperative moment to the second postoperative day) ]Subjective evaluation - Visual Analog Scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03179813
|Vitor Pereira Rodrigues|
|São Paulo, SP, Brazil, 04105000|