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

Dow University of Health Sciences

Status and phase: Unknown; Phase 4

Conditions: Impacted Third Molar Tooth

Treatments: Drug: Dexamethasone injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04319978

92 (308) 4448862

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Group A

Active Comparator group

Description:

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

Treatment:

Drug: Dexamethasone injection

Group B

Active Comparator group

Description:

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

Treatment:

Drug: Dexamethasone injection