Intraosseous vs Submucosal Injection of Dexamethasone

Tooth, Impacted Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04718077
• Other study ID #: Corticosteriod
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: January 2021
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tooth, Impacted

Intervention

Other:
• Intraosseus
IO dexamethasone injection Dexamethasone 4 mg
• Submucoal
SM dexamethasone injection Dexamethasone 4 mg

Locations

Country	Name	City	State
Egypt	Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt	Alexandria	Azarita

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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