Intraosseous vs Submucosal Injection of Dexamethasone

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

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.

Study Overview

• Status: Completed
• Conditions: Tooth, Impacted
• Intervention / Treatment: Other: Intraosseus; Other: Submucoal

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Azarita
    • Alexandria, Azarita, Egypt, 00203
      • Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IO dexamethasone injection	Other: Intraosseus; IO dexamethasone injection Dexamethasone 4 mg
Active Comparator: SM dexamethasone injection.	Other: Submucoal; SM dexamethasone injection Dexamethasone 4 mg

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: January 17, 2021
• First Submitted That Met QC Criteria: January 17, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 17, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth, Impacted
• Other Study ID Numbers: Corticosteriod

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No