The Effectiveness of Using a Single Post-operative Intramuscular Dexamethasone Injection on Patients with Surgical Extraction of Lower Third Molar

February 22, 2025 updated by: Yassir R. Al-khannaq

The Effectiveness of Using a Single Post-operative Intramuscular Dexamethasone Injection on Patients with Surgical Extraction of Lower Third Molar(Split Mouth Technique)

Evaluating the effectiveness of using a single immediate postoperative intramuscular Dexamethasone injection on pain, swelling, trismus and tissue healing in the first seven days.

Methods: A split mouth technique on 16 patients with bilateral similar impacted mandibular third molar were extracted; one side was given 8mg intramuscular injection of dexamethasone (study group) and the other side wasn't given injection (control group) and compare of the two sides were done in the following seven days.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

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

  • Iraq
      • Baghdad, Iraq
        • Department of Oral and Maxillofacial Surgery, College of Dentistry, University of Baghdad

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

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • bilateral similar impacted lower third molar
  • willing to do surgical extraction

Exclusion Criteria:

  • Patients who are not fulfill the inclusion criteria
  • allergic to dexamethasone
  • who has medical diseases
  • taking any medications
  • pregnant or lactating women

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: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: no intervention
Active Comparator: dexamethasone immediate injection postoperatively
intramuscular injection of a single dose 8mg dexamethasone immediate postoperatively after removal of impacted mandibular third molar
Drug: Dexamethasone
single 8mg post-operative intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post operative pain changes
Time Frame: each participant was seen at 1st, 3rd and 7th post-operative days
measurement of change in pain on visual scale analog from 10 to 1 , 10 mean the worst pain and 1 is least pain
each participant was seen at 1st, 3rd and 7th post-operative days
Change in post operative swelling
Time Frame: each participant was seen at 1st, 3rd and 7th post-operative days
The swelling was measured between two points marked on skin in millimeters using ruler
each participant was seen at 1st, 3rd and 7th post-operative days
Post operative Change in mouth opening
Time Frame: each participant was seen at 1st, 3rd and 7th post-operative days
The distance between upper and lower incisors was measured in millimeters using ruler
each participant was seen at 1st, 3rd and 7th post-operative days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tissue healing
Time Frame: Healing was assessed on the 7th postoperative day
Healing of extraction site was assessed by using Landry, Turnbull and Howley index
Healing was assessed on the 7th postoperative day

Collaborators and Investigators

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

Sponsor

Yassir R. Al-khannaq

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 (Actual)

April 20, 2024

Primary Completion (Actual)

September 15, 2024

Study Completion (Actual)

October 16, 2024

Study Registration Dates

First Submitted

January 30, 2025

First Submitted That Met QC Criteria

January 30, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 22, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 997124

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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