Dexamethasone Effect on Pain and Edema Following Mandibular 3rd Molar Surgery; Pre-operatively vs Post-operatively
Primary Purpose
Impacted Third Molar Tooth
Status
Unknown status
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Dexamethasone injection
Sponsored by
About this trial
This is an interventional supportive care trial for Impacted Third Molar Tooth
Eligibility 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
Sites / Locations
- Dr. Ishrat ul Ebad Khan Institute Of Health Sciences, DUHS, Ojha
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
Group A will receive single dose of dexamethasone IM 8mg 1 hour pre-operatively.
Group B will receive a single dose of dexamethasone IM 8mg immediately after surgery.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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"
Full Information
NCT ID
NCT04319978
First Posted
March 19, 2020
Last Updated
June 6, 2020
Sponsor
Dow University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04319978
Brief Title
Dexamethasone Effect on Pain and Edema Following Mandibular 3rd Molar Surgery; Pre-operatively vs Post-operatively
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 2020 (Anticipated)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
November 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences
4. Oversight
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
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Third Molar Tooth
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Group A will receive single dose of dexamethasone IM 8mg 1 hour pre-operatively.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Group B will receive a single dose of dexamethasone IM 8mg immediately after surgery.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone injection
Other Intervention Name(s)
Dexa
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Edema of face in the mandibular region
Description
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.
Time Frame
Change in edema will be assessed from baseline at 1st, 3rd and 7th day post-operatively
Secondary Outcome Measure Information:
Title
Change in Intensity of Pain in the extracted site: Visual Analog Scale (VAS)
Description
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"
Time Frame
Change in the intensity of pain will be assessed from baseline to 1st, 3rd and 7th day post-operatively.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arfa Baig, FCPS
Phone
03353046184
Email
arfa_awan@live.com
First Name & Middle Initial & Last Name or Official Title & Degree
Khadija Sultana, BDS
Phone
03412252793
Email
khadijasultana97@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arfa Baig, FCPS
Organizational Affiliation
DIKIOHS, DUHS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Ishrat ul Ebad Khan Institute Of Health Sciences, DUHS, Ojha
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75330
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arfa Baig, FCPS
Phone
03353046184
Email
arfa_awan@live.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dexamethasone Effect on Pain and Edema Following Mandibular 3rd Molar Surgery; Pre-operatively vs Post-operatively
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