Topical Hydrocortisone for Pain and Edema Control After Third Molar Surgery

Impacted Third Molar Tooth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03179813
• Other study ID #: 44657315.4.0000.0075
• Status: Completed
• Phase: Phase 4
• First received: May 29, 2017
• Last updated: March 6, 2018
• Start date: May 1, 2017
• Est. completion date: March 1, 2018

Study information

• Verified date: November 2017
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 1, 2018
• Est. primary completion date: January 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Impacted Third Molar Tooth
• Tooth, Impacted

Intervention

Procedure:
• Hydrocortisone
During the third molar extraction the hydrocortisone solution will be used in the test group
• Control
During the third molar extraction the saline solution will be used in the control group

Locations

Country	Name	City	State
Brazil	Vitor Pereira Rodrigues	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (7)

Ceccheti MM, Negrato GV, Peres MP, Deboni MC, Naclério-Homem Mda G. Analgesic and adjuvant anesthetic effect of submucosal tramadol after mandibular third molar surgery. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014 Mar;117(3):e249-54. doi: 10.1016/j.oooo.2012.05.015. Epub 2012 Sep 12. — View Citation

Grossi GB, Maiorana C, Garramone RA, Borgonovo A, Beretta M, Farronato D, Santoro F. Effect of submucosal injection of dexamethasone on postoperative discomfort after third molar surgery: a prospective study. J Oral Maxillofac Surg. 2007 Nov;65(11):2218-26. — View Citation

Herrera-Briones FJ, Prados Sánchez E, Reyes Botella C, Vallecillo Capilla M. Update on the use of corticosteroids in third molar surgery: systematic review of the literature. Oral Surg Oral Med Oral Pathol Oral Radiol. 2013 Nov;116(5):e342-51. doi: 10.1016/j.oooo.2012.02.027. Epub 2012 Aug 17. Review. — View 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. — View Citation

Ngeow WC, Lim D. Do Corticosteroids Still Have a Role in the Management of Third Molar Surgery? Adv Ther. 2016 Jul;33(7):1105-39. doi: 10.1007/s12325-016-0357-y. Epub 2016 Jun 10. Review. — View 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. — View Citation

UStün 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Edema	Change in edema measures	From the preoperative moment to the second postoperative day
Secondary	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)
Secondary	Pain	Subjective evaluation - Visual Analog Scale	Up to 2 days (from the immediate postoperative moment to the second postoperative day)