Effect of Dexamethasone and Methylprednisolone on Pain, Swelling and Trismus After Third Molar Surgery

May 21, 2012 updated by: Federal University of the Valleys of Jequitinhonha and Mucuri

Preemptive Effect of Dexamethasone and Methylprednisolone on Pain, Swelling and Trismus After Third Molar Surgery: a Split-mouth Randomized Triple-blind Clinical Trial

The main aim of the present study was to investigate the effect of preemptive dexamethasone and methylprednisolone to prevent pain, swelling and limitation in mouth opening following third molar extraction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Third molar surgery is often associated with significant post-surgical sequelae. The trauma caused to soft and bony tissue can result in considerable pain, swelling and trismus. Symptoms begin gradually having a peak 2 days after extraction. The use of corticosteroids such as dexamethasone and methylprednisolone can be a valuable tool when performing moderate to moderately severe oral surgical procedures. No clear consensus have emerged yet regarding patient selection, dosage, timing and type of administration of steroid. In this light, this clinical trial aim to compare the effect of preemptive dexamethasone and methylprednisolone to prevent pain, swelling and limitation in mouth opening following third molar extraction.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Diamantina, Minas Gerais, Brazil, 39100000
        • Universidade Federal dos Vales do Jequitinhonha e Mucuri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with indication of asymptomatic bilateral extractions of lower third molars
  • Aged 18 years or older;
  • Have a good health and no disease;

Exclusion Criteria:

  • Patients with history of any medication treatment within 15 days before the beginning of the research, history of allergy to the drugs, substances or materials used in this study, pregnancy or lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dexamethasone 8mg
Drug: Dexamethasone
Dexamethasone 8mg
Other Names:
  • Dexametasone acetate
EXPERIMENTAL: Methylprednisolone
Methylprednisolone 40mg
Drug: Methylprednisolone
Methylprednisolone 40mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative sequelae following thir molar extraction
Time Frame: up to seven days postoperative
During the postoperative intervals of 24, 48 and 72 hours and seven days, the swelling was determined using linear measures in the face and trismus by maximum mouth opening. The postoperative pain was self-recorded by the patient using visual analogue scale in 72 hours with an interval of eight hours
up to seven days postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
Analgesic consumption; duration of surgery
Time Frame: up to 7 days
up to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of the Valleys of Jequitinhonha and Mucuri

Investigators

  • Principal Investigator: Carlos Eduardo Alcântara, MsC, Federal University of the Valleys of Jequitinhonha and Mucuri

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

May 17, 2012

First Submitted That Met QC Criteria

May 21, 2012

First Posted (ESTIMATE)

May 23, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 23, 2012

Last Update Submitted That Met QC Criteria

May 21, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 053/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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