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Completed

NCT Number: NCT03179813

Topical Hydrocortisone for Pain and Edema Control After Third Molar Surgery

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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Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vitor Pereira Rodrigues

São Paulo, 04105000, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Hydrocortisone

Procedure

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

Control

Procedure

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

Primary outcomes

  1. Edema

    Time frame: From the preoperative moment to the second postoperative day

    Change in edema measures

Secondary outcomes

  1. 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)

  2. Pain

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

    Subjective evaluation - Visual Analog Scale

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 7, 2017
Registry last updated
Mar 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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