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Topical Hydrocortisone for Pain and Edema Control After Third Molar Surgery

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03179813
Enrollment
40
Registered
2017-06-07
Start date
2017-05-01
Completion date
2018-03-01
Last updated
2018-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impacted Third Molar Tooth

Keywords

hydrocortisone, third molar, oral surgery, postoperative pain, edema

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).

Interventions

PROCEDUREHydrocortisone

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

PROCEDUREControl

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

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
Yes

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;

Design outcomes

Primary

MeasureTime frameDescription
EdemaFrom the preoperative moment to the second postoperative dayChange in edema measures

Secondary

MeasureTime frameDescription
PainUp 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)

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026