Clinical trial NCT03179813: Topical Hydrocortisone for Pain and Edema Control After Third Molar Surgery
Official title: Topical Hydrocortisone for Pain and Edema Control After Third Molar Surgery: a Clinical, Crossover, Randomized, Double-blind, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Impacted Third Molar Tooth
Keywords: hydrocortisone
third molar
oral surgery
postoperative pain
edema
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2017-06-07
Enrollment: 40
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: 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;

Primary outcomes:
measure: Edema
timeFrame: From the preoperative moment to the second postoperative day
Secondary outcomes:
measure: Pain
timeFrame: Up to 2 days (amount of analgesic medication intake form the immediate postoperative moment to the second postoperative day)
measure: Pain
timeFrame: Up to 2 days (from the immediate postoperative moment to the second postoperative day)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Vitor Pereira Rodrigues
state: SP
Study officials:
References:
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citation: Pourdanesh F, Khayampour A, Jamilian A. Therapeutic effects of local application of dexamethasone during bilateral sagittal split ramus osteotomy surgery. J Oral Maxillofac Surg. 2014 Jul;72(7):1391-4. doi: 10.1016/j.joms.2013.12.025. Epub 2014 Jan 15.
citation: Mahmoud Hashemi H, Mohammadi F, Hasheminasab M, Mahmoud Hashemi A, Zahraei S, Mahmoud Hashemi T. Effect of low-concentration povidone iodine on postoperative complications after third molar surgery: a pilot split-mouth study. J Oral Maxillofac Surg. 2015 Jan;73(1):18-21. doi: 10.1016/j.joms.2014.06.454. Epub 2014 Jul 5.
citation: UStun Y, Erdogan O, Esen E, Karsli ED. Comparison of the effects of 2 doses of methylprednisolone on pain, swelling, and trismus after third molar surgery. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2003 Nov;96(5):535-9. doi: 10.1016/S1079210403004645.