Dexamethasone in Lower Third Molar Surgery

April 19, 2019 updated by: Miroslav Andric, University of Belgrade

Effectiveness of Different Application Modalities of Dexamethasone on Clinical Parameters and Quality of Life After Lower Third Molar Surgery

The aim of this randomized double-blind cross over clinical trial is to investigate effectiveness of different routes of applications (intramuscular and submucous at the site of surgery) and doses (4 mg and 8 mg) of Dexamethasone on swelling, trismus, pain and quality of life after lower third molar surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

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

  • Serbia
      • Belgrade, Serbia, 11000
        • School of Dental Medicine

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 to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy patients (ASA I)
  • Bilateral symmetrically impacted lower third molars according to Pel-Gregory's and Winter's classification

Exclusion Criteria:

  • Heavy tobacco smokers
  • Drug and / or alcohol abusers

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
Active Comparator: Intramuscular application
Intramuscular application of 4mg Dexamethasone
Procedure: Intramuscular application
Patient receive 4mg of Dexamethasone by intramuscular application
Experimental: Submucosal application
Submucosal application of 4mg Dexamethasone
Procedure: Submucosal application
Patients receive 4mg of Dexamethasone by submucosal application
Active Comparator: 4mg Dexamethasone submucosal
4mg Dexamethasone submucosal application
Drug: 4mg Dexamethasone submucosal
Patients receive 4mg of submucosal Dexamethasone
Other Names:
  • Dexasone
Experimental: 8mg Dexamethasone submucosal
8mg Dexamethasone submucosal application
Drug: 8mg Dexamethasone submucosal
Patients receive 8mg of submucosal Dexamethasone
Other Names:
  • Dexasone
Active Comparator: 4mg Dexamethasone postoperative
4mg Dexamethasone postoperative application
Procedure: 4mg Dexamethasone preoperative
Patients receive 4mg of Dexamethasone preoperatively
Experimental: 4mg Dexamethasone preoperative
4mg Dexamethasone postoperative application
Procedure: 4mg Dexamethasone postoperative
Patients receive 4mg of Dexamethasone postoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Facial swelling (using 3 facial measurements (in millimeters)
Time Frame: 1 day, 3 day, 7 day

We followed facial swelling 1, 3 and 7 days after intervention.

Swelling in the operation site will be evaluated using 3 facial measurements (in millimeters):

  1. Tragus - Midline.
  2. Tragus - Corner of the mouth
  3. Gonion - Lateral canthus.
1 day, 3 day, 7 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain (visual analog scale)
Time Frame: 1 day, 3 day, 7 day
Postoperative pain will be evaluated using a visual analog scale, 100 mm in length ranging from 0 for " no pain" to 100 for "the worse imaginable pain".
1 day, 3 day, 7 day
Postoperative trismus (difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery)
Time Frame: 1 day, 3 day, 7 day
Postoperative trismus will be measured as the difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery.
1 day, 3 day, 7 day
Postoperative discomfort (25-items custom made questionnaire)
Time Frame: 4 day, 7 day
Postoperative discomfort will be evaluated by filling out the 25-items custom made questionnaire that was designed to asses the patient's perception of adverse effects.
4 day, 7 day

Collaborators and Investigators

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

Sponsor

University of Belgrade

Investigators

  • Principal Investigator: Miroslav M Andric, DDS, PhD, School of Dental Medicine

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

January 1, 2014

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

April 2, 2015

First Submitted That Met QC Criteria

April 14, 2015

First Posted (Estimate)

April 15, 2015

Study Record Updates

Last Update Posted (Actual)

April 22, 2019

Last Update Submitted That Met QC Criteria

April 19, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36/11-2013

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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