Topical Hydrocortisone for Pain and Edema Control After Third Molar Surgery

Phase 4

Completed

• Conditions: Impacted Third Molar Tooth
• Interventions: Procedure: Hydrocortisone; Procedure: Control

• Registration Number: NCT03179813
• Lead Sponsor: University of Sao Paulo

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2017-05-29
• Study First Submitted QC: 2017-06-06
• Study First Posted: 2017-06-07
• Status Verified: 2017-11
• Primary Completion: 2018-01-03
• Study Completion: 2018-03-01
• Last Update Submitted: 2018-03-06
• Last Update Posted: 2018-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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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;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hydrocortisone group	Hydrocortisone	Intraoperative topical use of hydrocortisone as a irrigation solution in third molar surgery.
Control Group	Control	Intraoperative irrigation with saline solution.

Primary Outcome Measures

Name	Time	Method
Edema	From the preoperative moment to the second postoperative day	Change in edema measures

Secondary Outcome Measures

Name	Time	Method
Pain	Up to 2 days (from the immediate postoperative moment to the second postoperative day)	Subjective evaluation - Visual Analog Scale

Trial Locations

Locations (1)

Vitor Pereira Rodrigues; 🇧🇷 São Paulo, SP, Brazil