Intraosseous vs Submucosal Injection of Dexamethasone

Study Overview
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Brief Summary
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Thirty-eight patients were randomly divided into 2 groups; the intraosseous injection group of dexamethasone (4 mg) and the submucosal injection group. All surgeries were performed by one surgeon. Postoperative pain was evaluated by visual analog scale score immediately after surgery and on postoperative days 1, 3, and 7. Swelling (determined using two linear measurements) were assessed just before the surgery and on postoperative days 1, 3, and 7 by using a digital vernier caliper. Early healing of periodontal soft tissue wound was assessed by using Early Wound Healing Score (EHS) which composed of 3 parameters: clinical signs of re-epithelization (CSR), clinical signs of hemostasis (CSH), and clinical signs of inflammation (CSI) and were assessed on postoperative days 1, 7, and 14. Mouth opening (determined by measurement of the maximum inter-incisal distance) were assessed just before the surgery and on postoperative days 1, 3, and 7 by using a digital vernier caliper.

Official Title
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Effectiveness of Intraosseous Injection of Dexamethasone Following Impacted Mandibular Third Molar Removal (Randomized Controlled Clinical Trial)

Conditions
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Tooth, Impacted

Intervention / Treatment
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* Other: Intraosseus
* Other: Submucoal


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Patient complaining of impacted mandibular third molar mesioangular or horizontal, according to the Pell and Gregory classification 1933) Healthy patient (American society of anesthesiologists class I status) Patient age range from 18 to 40 years old. Patient without any local inflammation or pathology. Patient who will able to understand verbal and written instructions. Exclusion criteria Pregnant or breast-feeding women. Patient had anti-inflammatory drugs within 2 weeks before the procedure. Patient under radiotherapy or chemotherapy. Habits (heavy smoking and alcoholic). Allergy to drugs used in this study. Patient under anticoagulant or corticosteroid therapy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IO dexamethasone injection<br> | Other: Intraosseus<br>* IO dexamethasone injection Dexamethasone 4 mg<br>|
| Active Comparator: SM dexamethasone injection.<br> | Other: Submucoal<br>* SM dexamethasone injection Dexamethasone 4 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mouth opening | determined by measurement of the maximum inter-incisal distance assessed by using a digital vernier caliper | baseline, 1st, 3rd, 7th days | 
| change in swelling | assessed by measuring two linear references (horizontal and vertical) with digital vernier caliper Horizontal reference between the corner of the mouth and the tragus of the ear. Vertical reference between the lateral canthus and the angle of the mandible. | 1st, 3rd, 14th days | 
| change in pain scores | Pain will be assessed by using a visual analog scale (VAS) (13) immediately after surgery and on postoperative days 1, 3, and 7. | 1st, 3rd, 7th days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in early healing of periodontal soft tissue wound | The EHS is composed of 3 parameters: Clinical signs of re-epithelization (CSR). Clinical signs of haemostasis (CSH). Clinical signs of inflammation (CSI). | 1st, 7th, 14th days |