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

Impacted Third Molar Tooth Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04319978
• Other study ID #: 92 (308) 4448862
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 2020
• Est. completion date: November 2020

Study information

• Verified date: June 2020
• Source: Dow University of Health Sciences
• Contact: Arfa Baig, FCPS
• Phone: 03353046184
• Email: arfa_awan[@]live.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Impacted Third Molar Tooth
• Tooth, Impacted

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Dr. Ishrat ul Ebad Khan Institute Of Health Sciences, DUHS, Ojha	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Intensity of Pain in the extracted site: Visual Analog Scale (VAS)	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.