Clinical trial NCT04319978: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Impacted Third Molar Tooth
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in Edema of face in the mandibular region
timeFrame: Change in edema will be assessed from baseline at 1st, 3rd and 7th day post-operatively
Secondary outcomes:
measure: Change in Intensity of Pain in the extracted site: Visual Analog Scale (VAS)
timeFrame: Change in the intensity of pain will be assessed from baseline to 1st, 3rd and 7th day post-operatively.
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dr. Ishrat ul Ebad Khan Institute Of Health Sciences, DUHS, Ojha
state: Sindh
Study officials:
affiliation: DIKIOHS, DUHS
name: Arfa Baig, FCPS
role: PRINCIPAL_INVESTIGATOR
References: