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Topical Hydrocortisone for Pain and Edema Control After Third Molar Surgery

Primary Purpose

Impacted Third Molar Tooth

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Hydrocortisone
Control
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impacted Third Molar Tooth focused on measuring hydrocortisone, third molar, oral surgery, postoperative pain, edema

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

  • Vitor Pereira Rodrigues

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hydrocortisone group

Control Group

Arm Description

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

Intraoperative irrigation with saline solution.

Outcomes

Primary Outcome Measures

Edema
Change in edema measures

Secondary Outcome Measures

Pain
Quantitative evaluation (amount of analgesic medication intake)
Pain
Subjective evaluation - Visual Analog Scale

Full Information

First Posted
May 29, 2017
Last Updated
March 6, 2018
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03179813
Brief Title
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

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
January 3, 2018 (Actual)
Study Completion Date
March 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Third Molar Tooth
Keywords
hydrocortisone, third molar, oral surgery, postoperative pain, edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hydrocortisone group
Arm Type
Experimental
Arm Description
Intraoperative topical use of hydrocortisone as a irrigation solution in third molar surgery.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Intraoperative irrigation with saline solution.
Intervention Type
Procedure
Intervention Name(s)
Hydrocortisone
Intervention Description
During the third molar extraction the hydrocortisone solution will be used in the test group
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
During the third molar extraction the saline solution will be used in the control group
Primary Outcome Measure Information:
Title
Edema
Description
Change in edema measures
Time Frame
From the preoperative moment to the second postoperative day
Secondary Outcome Measure Information:
Title
Pain
Description
Quantitative evaluation (amount of analgesic medication intake)
Time Frame
Up to 2 days (amount of analgesic medication intake form the immediate postoperative moment to the second postoperative day)
Title
Pain
Description
Subjective evaluation - Visual Analog Scale
Time Frame
Up to 2 days (from the immediate postoperative moment to the second postoperative day)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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;
Facility Information:
Facility Name
Vitor Pereira Rodrigues
City
São Paulo
State/Province
SP
ZIP/Postal Code
04105000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27287853
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.
Results Reference
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PubMed Identifier
22902498
Citation
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.
Results Reference
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PubMed Identifier
17954317
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. doi: 10.1016/j.joms.2006.11.036.
Results Reference
background
PubMed Identifier
22981094
Citation
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.
Results Reference
background
PubMed Identifier
24576440
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.
Results Reference
background
PubMed Identifier
25249172
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.
Results Reference
background
PubMed Identifier
14600686
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.
Results Reference
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Topical Hydrocortisone for Pain and Edema Control After Third Molar Surgery

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