Topical Hydrocortisone for Pain and Edema Control After Third Molar Surgery

University of Sao Paulo

Status and phase: Completed; Phase 4

Conditions: Impacted Third Molar Tooth

Treatments: Procedure: Control; Procedure: Hydrocortisone

Study type: Interventional

Funder types: Other

Identifiers

NCT03179813

44657315.4.0000.0075

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: Accepts 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Hydrocortisone group

Experimental group

Description:

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

Treatment:

Procedure: Hydrocortisone

Control Group

Placebo Comparator group

Description:

Intraoperative irrigation with saline solution.

Treatment:

Procedure: Control