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Topical Hydrocortisone for Pain and Edema Control After Third Molar Surgery

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ClinicalTrials.gov Identifier: NCT03179813
Recruitment Status : Completed
First Posted : June 7, 2017
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Vitor Pereira Rodrigues, 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.

Condition or disease Intervention/treatment Phase
Impacted Third Molar Tooth Procedure: Hydrocortisone Procedure: Control Phase 4

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Topical Hydrocortisone for Pain and Edema Control After Third Molar Surgery: a Clinical, Crossover, Randomized, Double-blind, Controlled Study
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : January 3, 2018
Actual Study Completion Date : March 1, 2018


Arm Intervention/treatment
Experimental: Hydrocortisone group
Intraoperative topical use of hydrocortisone as a irrigation solution in third molar surgery.
Procedure: Hydrocortisone
During the third molar extraction the hydrocortisone solution will be used in the test group

Placebo Comparator: Control Group
Intraoperative irrigation with saline solution.
Procedure: Control
During the third molar extraction the saline solution will be used in the control group




Primary Outcome Measures :
  1. Edema [ Time Frame: From the preoperative moment to the second postoperative day ]
    Change in edema measures


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03179813


Locations
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Brazil
Vitor Pereira Rodrigues
São Paulo, SP, Brazil, 04105000
Sponsors and Collaborators
University of Sao Paulo

Publications:

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Responsible Party: Vitor Pereira Rodrigues, PhD candidate, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03179813     History of Changes
Other Study ID Numbers: 44657315.4.0000.0075
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vitor Pereira Rodrigues, University of Sao Paulo:
hydrocortisone
third molar
oral surgery
postoperative pain
edema
Additional relevant MeSH terms:
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Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Tooth, Impacted
Edema
Signs and Symptoms
Tooth Diseases
Stomatognathic Diseases
Pharmaceutical Solutions
Anti-Inflammatory Agents