Topical Hydrocortisone for Pain and Edema Control After Third Molar Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-03-01

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Impacted Third Molar Tooth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Hydrocortisone group

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

Group Type EXPERIMENTAL

Hydrocortisone

Intervention Type PROCEDURE

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

Control Group

Intraoperative irrigation with saline solution.

Group Type PLACEBO_COMPARATOR

Control

Intervention Type PROCEDURE

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

Interventions

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Hydrocortisone

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

Intervention Type PROCEDURE

Control

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

Intervention Type PROCEDURE

Eligibility Criteria

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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;

Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes