Dexamethasone Effect on Pain and Edema Following Mandibular 3rd Molar Surgery; Pre-operatively vs Post-operatively

June 6, 2020 updated by: Arfa baig, Dow University of Health Sciences

The Effect of IM Dexamethasone Administered Pre-operatively Versus Post-operatively on Pain and Edema Following Surgical Extraction of Mesio-angularly Impacted Mandibular 3 rd Molars

TThis is a comparative clinical study which will be conducted in OMFS department of DIKIOHS, DUHS Ojha Karachi. In this study the investigators will be comparing the effect of dexamethasone on pain and edema when administered pre-operatively vs post-operatively following surgery of impacted lower 3rd molars. Time duration of this study will be 2 months. A total of 100 patients will be considered in this study which will be equally divided into two groups; group A and group B (50 in each group).Group A will receive dexamethasone 1 hour pre-operatively while group B will receive the same post-operatively. All surgeries will be performed by the same maxillofacial surgeon and duration of surgery will be around 30-45 mins.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To compare the effect of dexamethasone (IM; 8mg) administered pre-operatively versus post-operatively on pain and edema following surgical extraction of mesio-angularly impacted mandibular 3rd molars.

This is a comparative clinical study. This study will be conducted in Oral Maxillofacial Surgery department of DIKIOHS, DUHS Teaching Hospital, Ojha, Karachi, Pakistan. Time duration of this study will be 2 months. A total of 100 patients will be considered in the study (50 in each group). Sample size was calculated through OpenEpi, taking mean values of post-operative 3rd day swelling (cm) of group A (12.15±0.78), group B (13.85±0.78) [Ref #], 95% confidence interval (two sided) and 80% of the power of the test. The sample size came out to be 8 patients (4 in each group). The sampling technique is Convenience Sampling. Patients will be randomly distributed into two groups; Group A & Group B. Group A will receive dexamethasone 8mg Intra-muscularly 1 hour pre-operatively while Group B will receive the same immediately after surgery. All surgeries will be performed by the same maxillofacial surgeon and duration of surgery will be around 30-45 minutes.

Study Type

Interventional

Enrollment (Anticipated)

100

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 Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75330
        • Dr. Ishrat ul Ebad Khan Institute Of Health Sciences, DUHS, Ojha
        • Contact:

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

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients coming to dental OPD of DIKIOHS, DUHS, Ojha with Mesioangular impactions
  • Age of patients: 20-50 years

Exclusion Criteria:

  • Patients with known co-morbidities
  • Patients allergic to dexamethasone
  • Patients with history of recent anti-inflammatory drug intake(NSAIDs, steroids, or antihistamines)
  • Pregnant/lactating females

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: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group A
Group A will receive single dose of dexamethasone IM 8mg 1 hour pre-operatively.
Drug: Dexamethasone injection
Dexamethasone is a synthetic corticosteroid. Dexamethasone is an adequate measure for reducing pain and edema in the post-operative recuperation period following 3rd molar surgery. A single dose of IM 8mg dexamethasone will be used for each patient.
Other Names:
  • Dexa
ACTIVE_COMPARATOR: Group B
Group B will receive a single dose of dexamethasone IM 8mg immediately after surgery.
Drug: Dexamethasone injection
Dexamethasone is a synthetic corticosteroid. Dexamethasone is an adequate measure for reducing pain and edema in the post-operative recuperation period following 3rd molar surgery. A single dose of IM 8mg dexamethasone will be used for each patient.
Other Names:
  • Dexa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Edema of face in the mandibular region
Time Frame: Change in edema will be assessed from baseline at 1st, 3rd and 7th day post-operatively
edema will be assessed using a measuring tape in three facial planes (M1,M2,M3) M1: Tragus of Ear to Corner of Mouth M2: Tragus of Ear to Pogonion M3: Lateral Canthus of Eye to Angle of Mandible.
Change in edema will be assessed from baseline at 1st, 3rd and 7th day post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Intensity of Pain in the extracted site: Visual Analog Scale (VAS)
Time Frame: Change in the intensity of pain will be assessed from baseline to 1st, 3rd and 7th day post-operatively.
Pain will be assessed using Visual Analog Scale (VAS). VAS is a psychometric response scale which can be used as a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. It is graded from 0 to 10; 0 indicating "No pain" while 10 indicating "excruciating/ unbearable pain"
Change in the intensity of pain will be assessed from baseline to 1st, 3rd and 7th day post-operatively.

Collaborators and Investigators

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

Sponsor

Dow University of Health Sciences

Investigators

  • Principal Investigator: Arfa Baig, FCPS, DIKIOHS, DUHS

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 (ANTICIPATED)

July 1, 2020

Primary Completion (ANTICIPATED)

September 1, 2020

Study Completion (ANTICIPATED)

November 1, 2020

Study Registration Dates

First Submitted

March 19, 2020

First Submitted That Met QC Criteria

March 22, 2020

First Posted (ACTUAL)

March 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 9, 2020

Last Update Submitted That Met QC Criteria

June 6, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 92 (308) 4448862

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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