Topical Hydrocortisone for Pain and Edema Control After Third Molar Surgery

March 6, 2018 updated by: Vitor Pereira Rodrigues, University of Sao Paulo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 04105000
        • Vitor Pereira Rodrigues

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hydrocortisone group
Intraoperative topical use of hydrocortisone as a irrigation solution in third molar surgery.
Procedure: Hydrocortisone
During the third molar extraction the hydrocortisone solution will be used in the test group
Placebo Comparator: Control Group
Intraoperative irrigation with saline solution.
Procedure: Control
During the third molar extraction the saline solution will be used in the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Edema
Time Frame: From the preoperative moment to the second postoperative day
Change in edema measures
From the preoperative moment to the second postoperative day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Up to 2 days (amount of analgesic medication intake form the immediate postoperative moment to the second postoperative day)
Pain
Time Frame: Up to 2 days (from the immediate postoperative moment to the second postoperative day)
Subjective evaluation - Visual Analog Scale
Up to 2 days (from the immediate postoperative moment to the second postoperative day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Actual)

January 3, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

May 29, 2017

First Submitted That Met QC Criteria

June 6, 2017

First Posted (Actual)

June 7, 2017

Study Record Updates

Last Update Posted (Actual)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 6, 2018

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 44657315.4.0000.0075

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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