Topical Hydrocortisone for Pain and Edema Control After Third Molar Surgery

NCT03179813 | Completed Phase 4 DMC

• 1 other identifier: 44657315.4.0000.0075
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Impacted Third Molar Tooth

Keywords

hydrocortisone; third molar; oral surgery; postoperative pain; edema

Outcome Measures

Primary Outcomes (1)

• Edema

  Change in edema measures

  From the preoperative moment to the second postoperative day

Secondary Outcomes (2)

• Pain

  Up to 2 days (amount of analgesic medication intake form the immediate postoperative moment to the second postoperative day)

• Pain

  Up to 2 days (from the immediate postoperative moment to the second postoperative day)

Study Arms (2)

Hydrocortisone group

EXPERIMENTAL

Intraoperative topical use of hydrocortisone as a irrigation solution in third molar surgery.

Procedure: Hydrocortisone

Control Group

PLACEBO COMPARATOR

Intraoperative irrigation with saline solution.

Procedure: Control

Interventions

Hydrocortisone PROCEDURE

During the third molar extraction the hydrocortisone solution will be used in the test group

Hydrocortisone group

Control PROCEDURE

During the third molar extraction the saline solution will be used in the control group

Control Group

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Vitor Pereira Rodrigues

São Paulo, São Paulo, 04105000, Brazil

Location

Related Publications (7)

• 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.

  PMID: 27287853 BACKGROUND

• Herrera-Briones FJ, Prados Sanchez 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.

  PMID: 22902498 BACKGROUND

• 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. doi: 10.1016/j.joms.2006.11.036.

  PMID: 17954317 BACKGROUND

• Ceccheti MM, Negrato GV, Peres MP, Deboni MC, Naclerio-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.

  PMID: 22981094 BACKGROUND

• 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.

  PMID: 24576440 BACKGROUND

• 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.

  PMID: 25249172 BACKGROUND

• 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.

  PMID: 14600686 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Edema

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Study Record Dates

• First Submitted: May 29, 2017
• First Posted: June 7, 2017
• Study Start: May 1, 2017
• Primary Completion: January 3, 2018
• Study Completion: March 1, 2018
• Last Updated: March 7, 2018

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)