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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04319978
Recruitment Status : Not yet recruiting
First Posted : March 24, 2020
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Arfa baig, Dow University of Health Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Impacted Third Molar Tooth Drug: Dexamethasone injection Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

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 Name: 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 Name: Dexa




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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"



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT04319978


Contacts
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Contact: Arfa Baig, FCPS 03353046184 arfa_awan@live.com
Contact: Khadija Sultana, BDS 03412252793 khadijasultana97@gmail.com

Locations
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Pakistan
Dr. Ishrat ul Ebad Khan Institute Of Health Sciences, DUHS, Ojha
Karachi, Sindh, Pakistan, 75330
Contact: Arfa Baig, FCPS    03353046184    arfa_awan@live.com   
Sponsors and Collaborators
Dow University of Health Sciences
Investigators
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Principal Investigator: Arfa Baig, FCPS DIKIOHS, DUHS
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Responsible Party: Arfa baig, Senior Registrar, Dow University of Health Sciences
ClinicalTrials.gov Identifier: NCT04319978    
Other Study ID Numbers: 92 (308) 4448862
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Tooth, Impacted
Tooth Diseases
Stomatognathic Diseases
Dexamethasone
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents