Intraosseous vs Submucosal Injection of Dexamethasone

Not Applicable

Completed

• Conditions: Tooth, Impacted
• Interventions: Other: Intraosseus; Other: Submucoal

• Registration Number: NCT04718077
• Lead Sponsor: Hams Hamed Abdelrahman

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-01
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30
• Status Verified: 2021-01
• Study First Submitted: 2021-01-17
• Study First Submitted QC: 2021-01-17
• Last Update Submitted: 2021-01-17
• Study First Posted: 2021-01-22
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IO dexamethasone injection	Intraosseus	-
SM dexamethasone injection.	Submucoal	-

Primary Outcome Measures

Name	Time	Method
Change in mouth opening	baseline, 1st, 3rd, 7th days	determined by measurement of the maximum inter-incisal distance assessed by using a digital vernier caliper
change in swelling	1st, 3rd, 14th days	assessed by measuring two linear references (horizontal and vertical) with digital vernier caliper; 1. Horizontal reference between the corner of the mouth and the tragus of the ear.; 2. Vertical reference between the lateral canthus and the angle of the mandible.
change in pain scores	1st, 3rd, 7th days	Pain will be assessed by using a visual analog scale (VAS) (13) immediately after surgery and on postoperative days 1, 3, and 7.

Secondary Outcome Measures

Name	Time	Method
change in early healing of periodontal soft tissue wound	1st, 7th, 14th days	The EHS is composed of 3 parameters: 1. Clinical signs of re-epithelization (CSR).; 2. Clinical signs of haemostasis (CSH).; 3. Clinical signs of inflammation (CSI).

Trial Locations

Locations (1)

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt; 🇪🇬 Alexandria, Azarita, Egypt