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

NCT04319978 | Unknown Phase 4 FDA Drug

• 1 other identifier: 92 (308) 4448862
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Impacted Third Molar Tooth

Outcome Measures

Primary Outcomes (1)

• Change in Edema of face in the mandibular region

  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 Outcomes (1)

• Change in Intensity of Pain in the extracted site: Visual Analog Scale (VAS)

  Change in the intensity of pain will be assessed from baseline to 1st, 3rd and 7th day post-operatively.

Study Arms (2)

Group A

ACTIVE COMPARATOR

Group A will receive single dose of dexamethasone IM 8mg 1 hour pre-operatively.

Drug: Dexamethasone injection

Group B

ACTIVE COMPARATOR

Group B will receive a single dose of dexamethasone IM 8mg immediately after surgery.

Drug: Dexamethasone injection

Interventions

Dexamethasone injection DRUG

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.

Also known as: Dexa

Group A; Group B

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dr. Ishrat ul Ebad Khan Institute Of Health Sciences, DUHS, Ojha

Karachi, Sindh, 75330, Pakistan

Location

MeSH Terms

Interventions

Calcium Dobesilate; Absorptiometry, Photon

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Arfa Baig, FCPS

  DIKIOHS, DUHS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arfa Baig, FCPS

CONTACT

03353046184; arfa_awan@live.com

Khadija Sultana, BDS

CONTACT

03412252793; khadijasultana97@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Registrar

Model Details: 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.

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: March 24, 2020
• Study Start: July 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: November 1, 2020
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)